Engineering

Atlas Copco Air Compressor , Purpose:

Atlas Copco Air Compressor , The purpose of this SOP is to define the standard operation and maintenance procedure of Atlas Copco Air Compressor and Air Dryer in order to ensure its smooth & trouble-free operation and generation of quality compressed air.

Atlas Copco Air Compressor , Scope:

This Standard Operating Procedure applies to the Atlas Copco Air Compressor (Model: ZT 75) and Air Dryer (Model: CD185+) which is located at the Utility area of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Air Compressor: An air compressor is a device that converts power (usually from an electric motor) into kinetic energy by compressing and pressurizing the ambient air.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the Air Compressor according to the SOP.
[][]To fill up the logbooks related to the air compressor.
[][]To do the maintenance according to the check list.

Manager,  Engineering

[][]To ensure that the operation and maintenance of air compressor are done properly.
[][]To approve any maintenance/plans related to the compressor.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Never touch any piping or components of the compressor during operation.
[][]Use only the correct type and size of hose end fittings and connections. When blowing through a hose or air line, ensure that the open end is held securely.

[][] A free end will whip and may cause injury. Make sure that a hose is fully depressurized before disconnecting it.
[][]Do not apply the air to skin or direct an air stream at people. Never use the air to clean dirt from your clothes. When using the air to clean equipment; do so with extreme caution and wear eye protection.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one checking or working on the machine.
[][]Never operate the machine when there is a possibility of taking in flammable or toxic fumes, vapors or particles.

[][]Never operate the machine below or in excess of its limit ratings.
[][]Keep all bodywork doors shut during operation.
[][]All maintenance work shall only be undertaken when the machine has cooled down.
[][]Before removing any pressurized component, effectively isolate the machine from all sources of pressure and relieve the entire system of pressure.
[][]Never use flammable solvents or carbon tetrachloride for cleaning parts. Take safety precautions against toxic vapors of cleaning liquids.
[][]Never use a light source with open flame for inspecting the interior of a machine, pressure vessel, etc.
[][]Make sure that no tools, loose parts or rags are left in or on the machine.
[][]Do not walk or stand on the roof of the unit.

System Description:

The Atlas Copco Air Compressor and Air Dryer manufactured by Atlas Copco has a capacity of 10.4 m3/min.
[][] Air drawn through an air filter is compressed in low-pressure compressor element and discharged to the intercooler.
[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers.
[][]A check valve is provided downstream of the silencer.
[][]The compressed air leaves the compressor via the air outlet.
[][]The compressor delivers oil-free, pulsation-free air.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
[][]After being compressed in compressor the oil free compressed air will be stored in a receiver tank.
[][]Air will be dried in the desiccant type dryer and then distributed through pipe line to the different production facility.

Operating Procedure:

Operation of compressor:

[][]Initial Start-up of compressor:
[][]Tight up all the flanges, nuts and bolts as instructed in the instruction manual of the compressor.
[][]Check that the gear casing is filled with oil; the level should be in the middle of sight-glass.
[][]The electrical installation must be earthed and protected by fuses in all phases. An isolating switch must be provided.
[][]Switch on the voltage. Start the compressor and stop it immediately. Check for correct direction of rotation (Clockwise) while the motor is coasting to a stop.
[][]An arrow on the gear casing indicates the correct rotation direction. If the rotation direction is wrong, switch off the voltage and reverse two incoming electric lines.
[][]Check the rotation direction of the fan motor. If the rotation direction is wrong, switch off the voltage and reverse the motor’s electrical connection.

[][]Open the air outlet valve.

[][]Switch on the voltage and check that voltage on LED (2) lights up.
[][]Press start button (1). The compressor starts running and automatic operation LED (3) lights up.

Be careful about the following:

[][]When the compressor is stopped and automatic operation LED (3) is alight, the compressor may start automatically.
[][]If the start/stop timer is active, the compressor may start automatically, even if it was stopped manually.

During Operation:

[][]Daily check the display (2) for readings and messages. Normally, the main screen indicates the compressor outlet pressure, the status of the compressor and the functions of the keys below the display.
[][]Always check the display and remedy the trouble if alarm LED (3) is alight or blinks.
[][]Regularly check the actual compressor status by pressing the down key from the main screen.
[][]The Operational Log Sheet (Annexure – I) of air compressor and dryer will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable.

[][]For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure:

[][]Frequently stopping the compressor using the emergency stop button may damage the compressor; only use the emergency stop button in case of emergency.

[][]Press the stop button (1): the compressor will stop and LED (2) will go out.
[][]Close the air outlet valve.
[][]To stop the compressor immediately, press emergency stop button (S2).

 Taking out of operation:

[][]Close the air outlet valve and stop the compressor.
[][]Switch off the voltage and disconnect the compressor from the mains.
[][]Shut down and depressurize all the parts.
[][]Drain oil and condensate circuits.
[][]Disconnect the compressor condensate piping from the condensate drain.

Operation of Air Dryer:

[][]Initial start-up
[][]To start up the dryer for the first time or after a long period of standstill, proceed as follows:
[][]Open the bypass valves of the dryer.
[][]Close the air supply from the compressor towards the dryer by closing the external inlet valve.
[][]Close the external outlet valve.
[][]Remove the silencers to prevent the silencers from getting clogged by the desiccant and wear a dust mask, safety glasses and ear protection. (This is only required at initial start-up or after the desiccant was replaced).
[][]Start the compressor and wait for pressure.
[][]Slowly open the external inlet valve.
[][]Check the connections of the dryer for air leaks and remedy if necessary.
[][]Switch the dryer on by putting main switch S1 in position I.
[][]Let the dryer operate for several hours with the external outlet valve closed.
[][]In case the silencers were removed, refit the silencers.
[][]Gradually open the external outlet valve.
[][]Close the bypass valves of the dryer.

Normal start

[][]If the dryer has not been used for more than 3 months, refer to previous section, In all other cases proceed as follows:
[][]Cut off the air supply from the compressor towards the dryer by closing the external inlet valve.
[][]Close the external outlet valve between the dryer and the dry air consumer.
[][]Start compressor and slowly open the external inlet valve.
[][]Switch the dryer on by putting main switch in position I.
[][]Gradually open the air outlet valve.
[][]Close the bypass valves of the dryer.
[][]Close the external inlet valve in case the compressor needs to be restarted. The high air speed in the start-up phase of the compressor may damage the desiccant.

Shutdown Procedure of Dryer:

[][]To stop the dryer, proceed as follows:
[][]Open the bypass valves of the dryer so that the application will still receive compressed air.
[][]Close the external inlet valve between the compressor and the dryer and the external outlet valve between the dryer and the dry air consumer.
[][]Let the dryer operate for a period without consumption, to depressurize the vessels.
[][]Switch off the dryer by putting main switch to position 0.
[][]If the dryer is stopped for a longer period, keep the external inlet and outlet valve closed to avoid the moisture from entering the dryer.
[][]Under no circumstances must compressed air be allowed to flow through the dryer when the electrical power is switched off. This will result in terminal failure of the desiccant material; causing regeneration will no longer be possible.

Maintenance Procedure:

Safety Instruction:

[][]Hang the Maintenance tag prior to any maintenance activity.
[][]Use protective clothing.
[][]Use proper tools.
[][]Isolate the system electrically and mechanically prior to maintenance.

General Instruction:

[][]Plan and procure spares and manpower prior to the maintenance works.
[][]Only trained personnel are to be engaged in maintenance work.
[][]After finishing the maintenance work, the area & the equipment should be cleaned & tagged out.
[][]Functional/operational checks are to be conducted after maintenance works have been done.
[][]Maintenance Log Book (Annexure – II) has to be filled up by the operator after performing scheduled maintenance.

Maintenance Program:

Daily Maintenance

[][]Clean the machine exterior and its surroundings.
[][]Check that condensate is discharged during loading.
[][]Check the oil level. Before starting, the level should be in the middle of the sight-glass.
[][]Check the display panel for information and service messages.

Weekly Maintenance

[][]Clean the inner side of the machine.
[][]Clean the air filters thoroughly.

Monthly Maintenance

[][]Check for possible leaks.

Quarter Yearly

Maintenance after 2000 hrs

[][]Check for damaged wiring or loose connections.
[][]Replace the air filter cartridge.
[][]Replace the oil filter cartridge.
[][]Check/replace the cooling air inlet filter.
[][]Replace the inlet and outlet filter cartridges of Air Dryer.
[][]Change the lubricating oil.

Maintenance after 4000 hrs

[][]Tighten the bolted connections.
[][]Tighten all the connecting terminals in the switch cabinet/electric motor.
[][]Test the safety valve function.
[][]Replace the silencers of Air Dryer.

Maintenance after 8000 hrs

[][]Perform the maintenance as it is in the Yearly maintenance schedule.
[][]Replace worn parts.

Maintenance after 40000 hrs

[][]Replace desiccant of air dryer.
[][]Revision of inlet valves and actuator.
[][]Replace the check valves.

Other Maintenance

[][]Oil and Oil Filter Change Procedure
[][]Run the compressor until warm.
[][]Press stop button, wait until the compressor has stopped, press emergency stop button (S2) and switch off the voltage to the compressor.
[][]Remove filler plug. Drain the compressor sump by opening drain valve. Close the valve after draining.
[][]Drain the oil cooler by removing its drain plug and vent plug.
[][]Drain the oil of the compressor elements. Yellow-painted drain plugs are provided on both elements.
[][]Remove the oil filter. Clean the filter seat, oil the gasket of the new filter and screw it into place until the gasket contacts the seat. Then tighten by hand.
[][]Fill the compressor sump to the middle of the oil level sight-glass with oil as specified in “Oil specifications”. Reinstall the filler plug.
[][]Switch on the voltage. Unlock the emergency stop button.
[][]Run the compressor for a few minutes. Stop the compressor. If necessary, top up the gear casing with oil to the middle of the sight-glass.

Air Filter Cleaning Procedure:

[][]Stop the compressor and switch off the voltage to the compressor.
[][]Remove the filter.
[][]Clean the filter by passing compressed air through the filter.
[][]After carrying out the service actions of the related service plan, the service warning must be reset.

Annexure:

Annexure – I: Operational Log Sheet.
Annexure – II: Maintenance Log Book of Atlas Copco Air Compressor and Air Dryer.

Lupamat Air Compressor,Purpose:

Lupamat Air Compressor, The purpose of this SOP is to define the standard operation and maintenance procedure of Air Compressor manufactured by Lupamat in order to ensure its smooth & trouble-free operation and generation of quality compressed air.

Lupamat Air Compressor, Scope:

This Standard Operating Procedure applies to the Lupamat Air Compressor of Model – LKV 37/10MI, which is located at the Utility area of General Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Air Compressor: An air compressor is a device that converts power (usually from an electric motor) into kinetic energy by compressing and pressurizing the ambient air.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the Air Compressor according to the SOP.
[][]To fill up the logbooks related to the air compressor.
[][]To do the maintenance according to the check list.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Never touch any piping or components of the compressor during operation.
[][]Use only the correct type and size of hose end fittings and connections. When blowing through a hose or air line, ensure that the open end is held securely. A free end will whip and may cause injury. Make sure that a hose is fully depressurized before disconnecting it.
[][]Do not apply the air to skin or direct an air stream at people. Never use the air to clean dirt from your clothes. When using the air to clean equipment; do so with extreme caution and wear eye protection.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one checking or working on the machine.
[][]Never operate the machine when there is a possibility of taking in flammable or toxic fumes, vapors or particles.

[][]Never operate the machine below or in excess of its limit ratings.
[][]Keep all bodywork doors shut during operation.
[][]All maintenance work shall only be undertaken when the machine has cooled down.
[][]Before removing any pressurized component, effectively isolate the machine from all sources of pressure and relieve the entire system of pressure.
[][]Never use flammable solvents for cleaning parts. Take safety precautions against toxic vapors of cleaning liquids.
[][]Never use a light source with open flame for inspecting the interior of a machine, pressure vessel, etc.
[][]Make sure that no tools, loose parts or rags are left in or on the machine.
[][]Do not walk or stand on the roof of the unit.

System Description:

The air compressor manufactured by Lupamat has a capacity of 5.03 m3/min.
[][] Air drawn through an air filter is mixed with the oil and compressed in screw type compressor.
[][] The compressed air – oil mixture is then passed through the oil separator to separate the oil.
[][]This compressed air is discharged through silencer and after coolers.
[][]The compressed air leaves the compressor via the air outlet.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
After being compressed in compressor the compressed air will be stored in a receiver tank.
[][]Air will be dried in the desiccant type dryer and then distributed through pipe line to the different production facility.

Operating Procedure:

Operation of compressor:

[][]Initial Start-up of compressor:
[][]Tight up all the flanges, nuts and bolts.
[][]Check the oil level inside the tank.
[][]The electrical installation must be earthed.
[][]Close the discharge valve before initial start – up.
[][]Switch on the voltage. Start the compressor by pressing Start Button and stop it immediately.
[][]Check for correct direction of rotation (Clockwise) while the motor is coasting to a stop.
[][]If the rotation direction is wrong, switch off the voltage and reverse two incoming electric lines.
[][]Check the rotation direction of the fan motor. If the rotation direction is wrong, switch off the voltage and reverse the motor’s electrical connection.

Start-up Procedure of compressor:

[][]Open the air outlet valve.
[][]Switch on the main circuit breaker.
[][]Press the Start button. The compressor starts running in automatic mode.

During Operation:

[][]Daily check the display for readings and messages. At the left middle of the main screen the line pressure, air / end pressure, air/oil temperature can be seen. At the middle of right side of the screen total working time, load working time information and the remaining time up to general service maintenance time.
[][]Always check the display and remedy the trouble if alarm is alight or blinks.
[][]The Operational Log Sheet (Annexure – I) of air compressor and dryer will be filled up on every hour by the operator.
[][]Photocopy of the all the approved forms will be used where easily applicable.
[][]For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure:

[][]Press the stop button; the compressor will stop when the outlet pressure is under 1 bar.
[][]If the pressure does not come under 1 bar within 5 minutes the compressor will stop by giving a failure alarm “the compressor cannot be stopped”.
[][]Close the air outlet valve.
[][]Cut the electricity from the main power. When shutting down after a normal day operation, empty out any water that may have stayed within the air tank.
[][]To stop the compressor immediately, press emergency stop button.
[][]Frequently stopping the compressor using the emergency stop button may damage the compressor; only use the emergency stop button in case of emergency.
[][]The compressor cannot be started without resetting the emergency switch.

Operation of Air Dryer:

Starting Procedure

[][]Hold down on-off button for 3 seconds.
[][]With the first start, all leds on the front panel flash one by one.
[][]At first, the hot air gets into dryer, +4 °C or +8°C led flashes. Then refrigerating compressor starts to work and related led flashes.
[][]Condenser fan unit starts only if the refrigerating compressor is running and/or condenser fan temperature is higher than +30°C.
[][] It switches itself “stop” when condenser fan temperature gets lower than +20°C or refrigerating compressor stops.
[][]Cooling process continues until temperature gets down to +2°C and condenser motor stops. Dryer switches itself “STOP” and Because of thermal storage feature of heat exchanger, keeps the heat for a while.
[][]When the heat rises up to +4°C motor starts again. System continues in this way.

Stopping Procedure of Dryer:

[][]To stop the dryer, proceed as follows:
[][]Close the external inlet valve between the compressor and the dryer and the external outlet valve between the dryer and the dry air consumer.
[][]Switch off the dryer by pressing ON/OFF button.
[][]If the dryer is stopped for a longer period, keep the external inlet and outlet valve closed to avoid the moisture from entering the dryer.

Maintenance Procedure:

Safety Instruction:
[][]Hang the Maintenance tag prior to any maintenance activity.
[][]Use protective clothing.
[][]Use proper tools.
[][]Isolate the system electrically and mechanically prior to maintenance.

General Instruction:

[][]Plan and procure spares and manpower prior to the maintenance works.
[][]Only trained personnel are to be engaged in maintenance work.
[][]After finishing the maintenance work, the area & the equipment should be cleaned & tagged out.
[][]Functional/operational checks are to be conducted after maintenance works have been done.
[][]Maintenance Log Book has to be filled up by the operator after performing scheduled maintenance.

Maintenance Program:

Daily Maintenance

[][]Clean the machine exterior and its surroundings.
[][]Check that condensate is discharged during loading.
[][]Check the oil level. Before starting, the level should be in the middle of the sight-glass.
[][]Check the display panel for information and service messages.

Weekly Maintenance

[][]Clean the inner side of the machine.
[][]Clean the air filters thoroughly.
[][]Check for possible leaks.
[][]Clean the condenser unit of Air Dryer with compressed air.
[][]Clean the cooler surface.
[][]Check the tightness of v-belt.

After 3000 hrs

[][]Clean the air filter elements.
[][]Check the viscosity of the oil and change it if necessary.
[][]Check for oil leakage.

After 5000 hrs

[][]Check for damaged wiring or loose connections.
[][]Check and replace the air hoses if necessary.
[][]Check and replace the oil hoses.
[][]Clean the air/oil separator tank.

After 10000 hrs

[][]Clean the intake air filter and change it if necessary.
[][]Clean the intake control valve.
[][]Clean the intake control valve o-ring and rubber pad and change it if necessary.
[][]Clean the air/oil pipe gasket and change it if necessary.
[][]Check the V-belt and change it if necessary.

After 20000 hrs

[][]Replace the electric motor bearings if it is necessary.

Annexure:

Annexure – I: Operational Log Sheet.
Annexure – II: Maintenance Log Book of Air Compressor and Air Dryer.

Diesel Generator, Purpose

Diesel Generator, The purpose of this SOP is to describe the procedure of operation and maintenance of the 1000 KVA diesel generator which is installed in the Generator room of Solid Block of XX Pharmaceuticals Ltd.

Diesel Generator, Scope

This SOP applies to the Cummins generator of Model No.: QST30-G4 and capacity 1000 KVA which is located at General block of XX Pharmaceuticals.

Definitions / Abbreviation:

[][]EHS : Environment Health and Safety
[][]PPE : Personal Protective Equipment
[][]SOP : Standard Operating Procedure

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required
[][]Engage technician/mechanic/operator/supplier in repair and maintenance work

Operators

[][]To operate the generator according to the SOP.
[][]To fill up the logbooks related to the Generator.
[][]To do the maintenance according to the check list.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Hearing protection must be used.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Do not smoke when put fuel in the tank.
[][]Clean away fuel which has been spilt. Material which has been contaminated by fuel must be moved to a safe place.
[][]Do not make adjustment that doesn’t understand.
[][]Do not remove the filler cap or any component of the cooling system while the engine is hot and while the coolant is under pressure, because dangerous hot coolant can be discharged.
[][]Turbochargers operate at high speed and at high temperatures. Keep fingers, tools and debris away from the inlet and outlet ports of the turbocharger and prevent contact with hot surfaces.
[][]Use extreme care if emergency repairs must be made in adverse conditions.
[][]The fuel injector units are actuated by high pressure engine lubricating oil. Do not remove any component of the high pressure system while the engine oil is under pressure, because dangerous oil can be discharged.
[][]Maintenance activity must be carried out by trained technician/operators.
“Under Maintenance” be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Engine Starting Procedure

Pre-Start Check

[][]Before the engine is started the operator should understand fully the reason for the controls and their use. The following check should be done before engine start.
[][]Make a general visual inspection on the engine and alternator. Check if there is any breakage, crack, leakage or looseness.
[][]Check the battery electrolyte level-fill with distilled water as necessary.
[][]Check that there is sufficient coolant level and if necessary, add the correct coolant
[][]Check that there is sufficient lubricating oil in the sump & Viscosity and, if necessary add lubricating oil.
[][]Fill the fuel tank with fuel of the correct specification.
[][]Check the air filter and its connection.
[][]Check the all electrical connections are tight.
[][]Check the condition and tension of the fan end engine alternator belts-tighten as necessary.
[][]Check all hoses for loose connections or deterioration tighten or replace as necessary.
[][]Check the battery connection cables. Take care to tighten the loosened battery terminals with spanner and, cover with special substance and keep clean in order to avoid oxidation
[][]Take out foreign materials such as keys, tools, cleaning wool, papers etc. on the engine and the Alternator.

Engine Start

[][]Reset the emergency stop.
[][]Press the reset button.
[][]Start key turn to the “ON” Position.
[][]After start key turn to “ON” position following are checked:
[][]Check for any abnormal noise or vibration.
[][]Check for fluid leakage or leaks in the exhaust system.
[][]Check the control panel for indications of abnormal operations, particularly abnormally high temperature or low oil pressure. The oil pressure should be in the normal range within about 10 seconds of starting.
[][]Switch the alternator circuit breaker to “ON” (Handle Up).

Caution:

[][]Load can now be applied to the generating set (Normally 2-3 minutes wait from pressing the start button).
[][]The maximum step load can be 70%-100% of rated power depending on the generating set model. Typically we run 80% of rated load.
[][]Do not operate the engine at high speeds without a load.
[][]Do not overload the engine.

Engine Stopping Procedure

[][]Turn off the load by switching output circuit breaker to “OFF” (Handle Down).
[][]Allow the generating set to run without load.
[][]After 2-3 minutes the key turn to the “OFF” position.
[][]In case of an emergency where immediate shutdown is necessary, the emergency stop push button should be pushed immediately without discounting the load.

Preventive Maintenance Planning

[][]The preventive maintenance periods apply to average conditions of operation. The schedule which follows must be applied at the Interval (hours or months) which occur first.

Daily or every 20 Hours after

[][]Visually inspect engine, generator, transfer switch and Control panel.
[][]Clean the machine exterior and its surroundings.
[][]Ensure that the coolant is at the correct level.
[][]Check Oil, Water and fuel leaks.
[][]Check the amount of lubricating oil in the sump.
[][]Check the fuel level in the fuel tank.
[][]Check the lubricating oil pressure at the panel display.
[][]Battery charge level.
[][]Drain Fuel/Water separator.
[][]Inspect the engine fan blades.
[][]Inspect the drive belt.
[][]Drain water from the fuel pre-filter.
[][]Check the intercooler and the coolant radiator for debris.

Weekly Maintenance

[][]Repeat Daily Check.
[][]Fuel level in main tank.
[][]Fuel lines and connections.
[][]Adequate fresh air to engine.
[][]Check hose and connections.
[][]Battery charging alternator belts.
[][]Inspect the engine fan blades.
[][]Inspect the fan belt.
[][]Check oil level (Governor Housing).
[][]Check exhausts leakage.
[][]Tighten connections.
[][]Check Panel display.
[][]Tighten covers.
[][]Check output voltage and frequency
[][]Operation under load.
[][]No unusual sounds.
[][]Terminals and connections normal color.
[][]Doors closed securely.

Monthly Maintenance

[][]Repeat weekly check
[][]Clean the air filters.
[][]Check All fittings, Clamps, fasteners etc
[][]Check generator air outlet

After 6 Months or every 200 Hours

[][]Repeat weekly check
[][]Clean air filters
[][]Change, lubricating oil
[][]Change the lubricating oil filters.
[][]Change, lubricating oil filters
[][]Change, fuel filters
[][]Drain sediment from main tank
[][]Change, lubricating oil
[][]Check, antifreeze
[][]Governor lubricate with grease, bearing of the fan hub.
[][]Check operating alarms and safeties

After 12 Months or 800 Hours

[][]Repeat Maintenance after 200 Hours.
[][]Check and adjust if necessary, the antifreeze.
[][]Test the level of coolant conditioner and adjust if necessary.
[][]Check the condition of the drive belt.
[][]Change the engine lubricating oil.
[][]Change the canister of the lubricating oil filter.
[][]Change the air filter (or earlier if in extremely dusty conditions).
[][]Clean or renew the air filter element Check for damaged wiring or loose connections.
[][]Check radiator hoses for wear and cracks.
[][]Check exterior of radiator for obstructions.
[][]Clean engine.
[][]Generator rotor and stator with compressed air.
[][]Check water circulating pump.
[][]Check Circuit breakers and fuse holders.
[][]After 24 Months or 2,000 Hours
[][]Check the turbocharger bearing clearance
[][]Check the exhaust restriction
[][]Check the valves settings
[][]Check the injectors settings
[][]Check vibration damper
[][]Clean Turbocharger compressor wheel and diffuser.

After every 10000 hours

[][]Overhauling of full generator.
[][]Ensure that the turbocharger impeller and the turbocharger compressor casing are cleaned.
[][]Ensure that the alternator, the starter and the turbocharger are checked.

Annexure

Annexure-I: Maintenance logbook of 1000 KVA diesel generator
Annexure-II : Log sheet for 1000 KVA diesel generator

Purified Water, Purpose:

Purified Water  , The purpose of this SOP is to define the Automatic Operation of Purified Water Generation Plant manufactured by Watertown, China in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Purified Water, Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, China, which is located at the Utility area (roof top) of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]RO: Reverse Osmosis.
[][]EDI: Electro De Ionizer.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To operate the PW plant according to the SOP.
[][]To fill up the logbooks related to the PW plant.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]The PW plant manufactured by Watertown has a capacity of 3000 L/hr. The plant has Raw water pretreatment and RO/EDI sections.
[][]In Raw water pretreatment portions the water is filtered through Multi Grade Filter and Active Carbon Filter respectively. After that, the water is softened with the softeners.
[][]There are two softeners of which one stands by while running another one. The softeners are regenerated by Brine solution. There are two dosing systems in pretreatment section.
[][]One is Clotech (NaClO) and another is Sodium Meta Bi Sulphite (SMBS) dosing.
[][]The NaClO dosing is used to add Chlorine which acts as a disinfectant. This chlorine is removed in the Active Carbon Filter.
[][]The SMBS dosing is used after active carbon filter to remove the remaining chlorine.
[][]After being softened, the water is treated through two stage Reverse Osmosis (RO) system and Electro De Ionizer (EDI).
[][]Finally, the purified water is stored in the PW storage tank.
[][]Two dosing systems are used in this section: Anti Silicant and NaOH dosing.
[][]NaOH dosing is used to control the pH and anti silicant dosing is used to reduce the silica from the water.

Operating Procedure:

[][]Automatic operation of PW plant:

Starting of PW plant:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Enter on that screen.
[][]Then the following screen will appear.
[][]Press “Parameter setting**” button to check the parameters and a box will appear for user ID and Password.
[][]Then the screen will appear to see the parameters. Press “setting2” to see the other parameter settings
[][]Then the screen will appear.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Auto off” button. So, the system will be operated sequentially in automatic mode. In automatic mode the Multi Grade Filter and Active Carbon Filter will be reversely washed and then the RO will be washed.
[][]The softener will be regenerated automatically when the water flow rate is 100 Ton.

[][]After completing reverse washing normal production of PW will start.

During Operation:

[][]To see any alarm press the “Alarm status” button in . Following screen will appear:

[][]By pressing the button “ ” the alarms will be acknowledged and stored in the alarm history. All the alarms in the alarm history can be watched in the “History Alarm” section by pressing the Up and Down arrow.
[][]There is an online data logger which logs the conductivity of water after softener, 1st RO, 2nd RO and EDI.
[][]The real time curve can be seen by pressing the “Real Time Curve” button.
[][]The Daily Operational Log Sheet (Annexure – I) of PW plant will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:

“This is a computer generated report. The format is as per the original approved form.”

Stopping procedure of PW plant:

[][]To stop the plant press “Auto on” button in the “Pretreatment Flowchart status” screen.
[][]Switch off the main breaker to cut the electricity.
[][]Close the line of compressed air and other utilities.

Annexure:

Annexure – I: Daily Operational Log Sheet of PW Plant.

Active Carbon Filter, Purpose:

Active Carbon Filter, The purpose of this SOP is to define the procedure of sanitization of Active Carbon Filter, RO and EDI of Purified Water Generation Plant manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Active Carbon Filter, Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, which is located at the Utility area (roof top) of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]ACF: Active Carbon Filter.
[][]RO: Reverse Osmosis.
[][]EDI: Electro De Ionizer.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Operation & Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To sanitize the ACF, RO and EDI according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be sure that the steam line is insulated.
[][]Do not touch the hot water pipe line with bare hands.
[][]Check that there is no leakage in the steam or hot water line.
[][]Ensure all the utilities before doing any operation.
[][]Ensure that the water level in the water storage tank is at least 35%.

Framework Description:

[][]The PW plant made by Watertown has a limit of 3000 L/hr. The plant has Raw water pretreatment and RD/EDI areas.
[][] In pretreatment segment crude water is sifted through MGF and ACF separately.
[][] Then, at that point, this crude water is gone through the conditioner to lessen the hardness and is at long last treated with the RO and EDI to get the refined water of wanted determinations.
[][]The disinfection of ACF, RO and EDI is finished by utilizing heated water at a temperature of around 80°C.
[][] There are two hotness exchangers in pretreatment area and RO/EDI segment to create the boiling water with the assistance of modern steam.
[][]After disinfection of RO and EDI cooling is done at a temperature of 30 ± 5°C.

Automatic Sanitization Procedure:

Sanitization of ACF:

[][]Close the manual butterfly valve V47-03.
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.

Press Enter on that screen.

[][]Then the following screen will appear. Press “Parameter setting**” button to check the parameters sanitization and a box will appear for user ID and Password.
[][]Then the following screen will appear to see the parameters. Press “setting2” to see the other parameter settings.
[][]Then the screen will appear.
[][]Press the “Exit” button to go to the menu navigation page
[][]Press the “sanitization***” button and give user ID and password to go to the sanitization page.
[][]In the sanitization page press the “Auto ON” button for Automatic operation.
[][]In the sanitization page press “Carbon filter Sanitization” for sanitization of ACF.
[][]Then the following screen will appear. Press the “Carbon filter Sanitization OFF” button to start the sanitization automatically. Normally the sanitization temperature is approx. 80°C for a period of 60 mins.
[][]During sanitization fill up the operation log sheet (Annexure – I).
[][]Natural cooling procedure is used to cool the ACF after sanitization.

Sanitization of 1st stage RO:

[][]Close the manual butterfly valve V50-22.
[][]In the sanitization page (Figure 06) press the “RO I Sanitization” button. Then the following screen will appear. Press “RO I Sanitization OFF” button on that screen to sanitize the 1st stage RO automatically.
[][]The sanitization temperature of 1st RO is as 80 ± 3°C for 60 mins.
[][]After doing sanitization cooling is done at a temperature of 30 ± 5°C by flowing cooling water.
[][]Fill up the operational log sheet (Annexure – I) during sanitization.

Sanitization of 2nd stage RO:

[][]In the sanitization page (Figure 06) press the “RO II Sanitization” button. Then the following screen will appear. Press “RO II Sanitization OFF” button on that screen.
[][]Cooling procedure is as same as it is for 1st stage RO.

Sanitization of EDI:

[][]Close the manual diaphragm valve of bypass line of membrane contactor.
[][]In the sanitization page (Figure 06) press the “EDI Sanitization” button. Then the following screen will appear. Press “EDI Sanitization OFF” button on that screen.
[][]After sanitization RO and EDI are cooled down to 30°C ± 5°C by supplying cooling water.
[][]Fill up the operational log sheet during whole sanitization and cooling period.

Annexure:

Annexure – I: Operational Log Sheet for Sanitization of ACF, RO and EDI

Chiller Operation , Purpose

Chiller Operation, The purpose of this SOP is to define the operation and maintenance procedure of Chillers of XX Pharmaceuticals Ltd.

Chiller Operation , Scope

This SOP applies to the Chillers manufactured by Trane, USA which is located at the roof top area of Sterile and Sterile blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]AHU: Air Handling Unit.

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of chillers.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To engage technician/mechanic/operator/supplier in repair and maintenance work.

Operators/Technician

[][]To operate the chiller according to the SOP.
[][]To fill up the logbooks related to the Chiller.
[][]To do the maintenance job according to the schedule.

Head of Engineering

[][]To ensure that the operation and maintenance of Chiller are done properly.
[][]To approve any maintenance/plans related to the Chiller.

Head of Quality Assurance

[][]To approve this SOP
[][]To ensure overall implementation of this SOP.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. [][]Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]“Under Maintenance” tag must be put while doing maintenance tasks.

System Description:

[][]Chiller is used to produce chilled water which is used in AHU’s cooling coil to cool the air. There are two chillers at the roof top area of Cephalosporin block and two at the roof top area of General Block. Each chiller has capacity of 250 Ton.
[][]The chiller works according to the Vapor Compression Refrigeration Cycle. There is an evaporator (heat exchanger) to chill the water by exchanging heat with the refrigerant. The refrigerant used in this system is R134a.

[][] The vapor refrigerant from the evaporator is sucked into the compressor and compressed to a higher pressure. There is a water cooled condenser to cool the refrigerant. The flow of refrigerant is controlled by using an expansion valve before entering into the evaporator.

Pre-Start Check:

[][]Check the power supply voltage within the utilization range.
[][]Verify that all refrigerant valves are “OPEN”.
[][]Check the chilled water.
[][]Check the Condenser water.
[][]Check cooling Tower water level.
[][]Check the fused-disconnect switch (es) that supplies power to the chilled water pump starter and the condenser water pump starter.
[][]Check all piping for leakage.
[][]Check the chilled water and condense water valve are “OPEN”.
[][]Visually inspect the chilled water pressure and condenser water pressure.
[][]Check the voltage of chiller.

Starting procedure:

[][]Following steps are followed to start the chillers
[][]Turn chiller circuit breaker (Panel Board) handle to “ON” Position.
[][]Start the chilled water pump
[][]Start Condenser water pump.
[][]Check the evaporator water flow.
[][]Check the condenser water flow.
[][]Start the cooling tower fan.
[][]After 10-30 Seconds Figure-I will be displayed.
[][]For checking condenser and evaporator circulating water we have to go to report option and check water flow.
[][]Touch the Report key and check water flow for condenser and chilled water circulating pump and oil temperature (Figure-II).
[][]After checking water flow, check the Setting of parameters.
[][]For setting parameter touch the” Setting” Key. Figure-III.
[][]Go back to Main screen menu and then touch the’ AUTO” key.
[][]After pressing the “AUTO” Figure-IV is displayed.

During Operation:

[][]Fill up the operational log book of chillers while the chillers are running on every 2 hours.

Stopping Procedure:

[][]At first Unlock the screen
[][]Touch the “STOP’’ key on screen.
[][]After stopping the chiller 5-10 minutes later
[][]Stop the condenser water pump.
[][]Stop chilled water circulating pump.
[][]Stop Cooling Tower Fan.

Chiller Preventive Maintenance Procedure:

[][]Use of a periodic maintenance program is important to ensure the best possible unit performance and efficiency.
[][]Fill up the maintenance log sheet of Chillers after doing maintenance.

Daily Maintenance

[][]Check the chiller’s evaporator and condenser pressures, and discharge oil pressure.
[][]Check the oil level in the chiller oil sump.
[][]Clean the chiller outside and surroundings.
[][]Check setting and operation of all controls and safety devices.

Weekly Maintenance

[][]Clean the environment of chiller room.
[][]Clean outside of the chillers, chilled water pumps.
[][]Clean outside of the condenser water pump.
[][]Check the electrical connection.

Monthly Maintenance

[][]Clean all water strainers in both the chilled and condensing water piping system.
[][]Measure the oil pressure drop. Replace oil filter if required.
[][]If operating conditions indicate a refrigerant shortage, leak checks the unit and confirm using soap bubbles.
[][]Repair all leaks.
[][]Check the motor bearing.
[][]Grease all pumps.

Annually Maintenance

[][]Check all isolators of pumps.
[][]Check starter contactors for wear and replace if required.
[][]Check motor winding insulation.
[][]Check motor amps draw.
[][]Clean condenser tubes.
[][]Check water pipeline for any leakage.
[][]Change the chilled water, refill with chemical.
[][]Change the condenser water.
[][]Check the evaporator and condenser flow switches.

Annexure

Annexure-I: Operational log sheet of Chillers
Annexure-II: Maintenance log sheet of Chillers

Operation & Maintenance of AHUS , Purpose

Operation & Maintenance of AHUS , The purpose of this SOP is to define the operation and maintenance procedure of Air Handling Units of Sterile Block of XX Pharmaceuticals Ltd.

Operation & Maintenance of AHUS , Scope

This SOP applies to all the AHUs which are located in the Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]AHU: Air Handling Unit (AHU)
[][]EHS: Environment, Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering (Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of AHUs.
[][]To check the log books.

Operators/Technician

[][]To operate the AHUs according to the SOP.
[][]To do the maintenance job according to the schedule.
[][]To fill up the operation and maintenance log book.

Head of Engineering

[][]To approve any maintenance/plans activities related to the AHUs.

Head of Quality Assurance

[][]To approve this SOP.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. [][]Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) such as masks, safety glass, boots etc. appropriate to the job must be worn.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Maintenance activity must be carried out by trained technician/operators.

Filters:

[][]Filtration is ordinarily positioned first in the AHU to keep every one of the downstream parts clean. Contingent on the grade of filtration required, regularly channels will be organized in (at least two) progressive manages an account with a coarse-grade channel gave before a fine-grade channel, or other “last” filtration medium.

[][] The coarse-grade channel is less expensive to supplant and keep up with, and in this manner safeguards the more costly channels.

Heating and/or cooling coil:

[][]Air taking care of Unit needs to give warming, cooling, or both to change the stockpile air temperature, and dampness level contingent upon the area and the application.

[][] Chilled water from the chiller is gone through a twisting container of the cooling curl, heat trade among water and air. Blades are appended to the cylinders effectively increment the surface for heat move to water from air.

[][]Boiling water from the high temp water age framework is gone through a twisting container of the warming loop, heat trade between boiling water and air.

[][]Blades are appended to the cylinders increment surface for heat move to air.

Blower/Fan/Motor:

[][]In the air handling unit fan/motor is used for supplying or extracts air from room. Depending on the size of AHU more than one fan/motor is installed.

Dampers:

[][]In AHU dampers are provided to control the flow of conditioned air to the room.

Pre-Start Check

[][]Check that the electrical connection is supplied.
Ensure that the chilled water is supplied to the cooling coil.
[][]Ensure that the hot water is supplied to the heating coil.
[][]All maintenance panels are to be closed and check all maintenance panels and locks for perfect position.
[][]Make sure that filters have been installed properly in their places.
[][]Make sure all filters media are installed in correct airflow direction.
[][]Starting Procedure
[][]Power ON for VSD.
[][]Press “Hand” Button.
[][]Press Start Button.

During Operation

[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of AHUs will be filled up once a week by the operator. The reading of magnehelic gauges will be used to monitor whether the filter is blocked.

[][] If the pressure reaches the maximum limit as stated in the filters will be changed or cleaned according to the described procedure in that SOP.

[][] Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure

[][]Press the Stop (Red) button.(See Figure-I)
[][]Power off for VSD.

Preventive Maintenance

[][]At first switch off power supply /isolate the AHU from power supply. The maintenance job is performed by trained personnel. “Under Maintenance” be displayed in a prominent position on a machine
[][]undergoing maintenance work.

Fan/Motor

[][]Check for soiling, corrosion, damage and tendency of excessive vibration.
[][]Check the electrical connection.
[][]Check that all bolts, nuts and flexible connection are securely fixed.
[][]Check that vibration isolator mounts is functioning well.
[][]Inspect for any obstructions or blockages at air intakes and discharges.
[][]Check fan bearing are secured and no undue noise by observe/listen using metal bar as a conductor.
[][]Check noise or knocking from bearing, replace both bearings.
[][]Check fan bearing and lubricate with grease.
[][]Check whether the fan impeller rotates freely.

Drive Belt

[][]Belts that are split or have frayed edges or any other sign of damage must be replaced in full set.
[][]Check the belt tension and alignment, retention and realign if necessary.
[][]Check drive belt, if damage replace belt.

Coil Section

[][]Ensure that coils are cleaned.
[][]Check for any leakage in coil.
[][]Ensure coil fins are not damage when performing dry/wet cleaning.

[][]Check that drain pan and drain trap are free from blockage and water accumulation at pan.

Filter Section:

[][]Disposable filters must be replaced each time when pressure drop reaches the indicated by dirty condition by magnehelic gauges. Washable filters must be cleaned periodically. For filters changing and cleaning procedure follow the SOP..

Dampers:

[][]Check for dirt accumulation, damage, and sign of corrosion.
[][]Clean with cloth or high pressure air.
[][]Check damper blade by turning manually or central control for smooth operation.

Preventive Maintenance Schedule

[][]During maintenance work the equipment must be electrically isolated. After performing maintenance works maintenance log book (as same as Annexure – II) has to be filled up by the operator.

Weekly Maintenance

[][]Check and clean fan
[][]Check Fan for excessive vibration.
[][]Check Fan belt.
[][]Check fan motor bearing.
[][]Check the functioning of auto actuator valves of chilled and hot water line.

Monthly Maintenance

[][]Check and Clean Motor.
[][]Check the belt drive tension.
[][]Check or replace V-belt condition.
[][]Check filter.
[][]Check nuts and bolts and tighten it if necessary.
[][]Grease the motor if necessary.

Quarter yearly Maintenance

[][]Check Vibrator Isolator.
[][]Check the electrical connection.
[][]Check the bearing for motor.
[][]Check drain trap clog.

Half Yearly Maintenance

[][]Check fan bearing.
[][]Check motor bearing.
[][]Check bolt and nut tighten.
[][]Check fin block.
[][]Check coil leakage.
[][]Check dirt accumulation of damper & Heater.
[][]Check sign of damage.
[][]Check position of damper.

Yearly Maintenance

[][]Servicing cooling coil and heating coil.
[][]Check/treat/repair corrosion of coil.
[][]Check/repair Electrical control box.
[][]Check/Replace Circuit Breaker.
[][]Check/replace internal lighting.

Annexure

Annexure-I: Differential Pressure Monitoring Log sheet of AHUs
Annexure-II: Maintenance Log Book of AHUs

HEPA Filter Cleaning , Purpose:

HEPA Filter Cleaning , The purpose of this SOP is to define the cleaning and changing procedure of G4, F7, F9 and HEPA filters of HVAC system of XX Pharmaceuticals Ltd.

HEPA Filter Cleaning , Scope:

This Standard Operating Procedure applies to the G4, F7, F9 and HEPA filters of HVAC system installed at Sterile and Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure
[][]AHU: Air Handling Unit
[][]G4 Filter: G4 filters are used as pre filters inside the AHUs and in low return line of rooms of HVAC system. This is also known as coarse graded filter
[][]F7 and F9 Filter: F7 and F9 filters are used as intermediate filters inside the AHUs of HVAC system. These are factory fabricated and mounted with galvanized steel or plastic frames
[][]HEPA: High Efficiency Particulate Air
[][]DOP: Di – Octyl Phthalate
[][]PAO: Poly Alpha Olefin

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for performing cleaning/changing operation smoothly.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators/Technician

[][]To clean/change the filters according to the SOP.
[][]To fill up the log sheets.

Manager, Engineering

[][]To ensure that the cleaning/changing of filters are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Do not open the doors of AHU while the motor is running.
[][]Do not wash the filters beside the AHUs.
[][]Use personal protective equipment and clothing as necessary at the time of performing cleaning/changing work.
[][]Be careful about the hot water line.

System Description

[][]In HVAC system, the filtration of air is done in three stages to remove the particulates from the air. The stages are: primary, secondary and tertiary stages.

Primary stage:

[][]Coarse graded filters are used in primary stage. The grade of this filter is G4. This type of filter is washable. This is also used in the low return duct line of AHUs. This type of filters are used to remove the coarse particles.

Secondary stage:

[][]After primary stage filtration the air is filtered in secondary stage filter inside the AHUs. Normally, the secondary stage filters are of F7/F9 graded. The bag type F7 filter is washable but cartridge and flat type F7 and F9 filters are not washable. They have to be replaced after being blocked with particles.

Tertiary stage:

[][]The air is finally filtered by the HEPA filters in tertiary stage. In some cases, filtration is done by the HEPA filters after secondary stage inside the AHU followed by terminal HEPA filter. Otherwise, HEPA filter is used only in the terminal of supply duct. These filters are neither washable nor cleanable rather than these are replaced or changed in case they fail the filter integrity test commonly known as DOP/PAO test.
[][]Monitor the differential pressure in the magnehelic gauge across the filters of AHUs in the log sheet.  If the differential pressure is beyond the set limit, then clean/change the filters.

Cleaning Procedure

[][]Cleaning of G4 and F7 (bag type) filters:
[][]Switch off the power of AHU and wait until the motor rotation is fully off.
[][]Open the door of the filter section and unmount the filter from its frame.
[][]Take the filter to the wash area at the roof top of both cephalosporin and general blocks.
[][]Wash the filter with water. Then, use any kind of non ionic cleaning agent to clean the filter.
[][]After cleaning the filters are dried.
[][]During cleaning a lot of dust may come out from the filters. So, use mask, goggles, hand gloves and other clothes to be safe from any harmful dust.
[][]After drying set the filters in the filter frame.
[][]The G4 filters of low return and inside the AHUs are cleaned once a week and every 15 days respectively for periodic maintenance. The F7 (bag type) filters are cleaned once a month.
[][]Fill up the log sheet (Annexure – I) after performing the activities.

Changing Procedure

[][]Changing of G4, F7, F9 filters:
[][]Both the G4 and F7 (bag type) filters are changed when filters cannot filter the air although it has been cleaned.
[][]Monitor the differential pressure across the filters. If the differential pressure across F7 (cartridge and flat type) and F9 filters is more than 500 Pa, the filters have to be changed. Both of these filters are changed once in a year for periodic maintenance.
[][]To change the filters follow the steps 1 to 2 of previous section.
[][]Take the filters to the dispose area.
[][]Destroy the filters in the dispose area abiding by the proper safety rules.
[][]Set a new filter.
[][]Fill up the log sheet (Annexure – II).

Changing the HEPA filters:

[][]The differential pressure across the HEPA filters (fitted inside the AHUs) is monitored. These filters are changed when the differential pressure exceeds 300 Pa.
[][]The integrity test (DOP/PAO) is performed at a defined interval for every HEPA filters. The filter is changed if it fails the test.
[][]To change the HEPA filters follow the previous steps
[][]After replacing the filter fill up the log sheet (Annexure – II).

Annexure:

Annexure – I: Log sheet for cleaning of G4 & F7 (bag type) filters.
Annexure – II: Log sheet for changing of G4, F7, F9 and HEPA filters.

Pure Steam, Purpose:

Pure Steam, The purpose of this SOP is to define the Operation of Pure Steam Generation System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified pure steam.

Pure Steam, Scope:

This Standard Operating Procedure applies to the pure steam generation system manufactured by Watertown, which is located at the Utility area (roof top) of Sterile block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PS: Pure steam.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To operate the system according to the SOP.
[][]To fill up the logbook.

Head of Engineering

[][]To ensure that the operation of PW plant are done properly.

Head of Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burning.
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]Pure steam is generated by heating the purified water. In this plant it is generated during the production of Water For Injection.
[][]So, the main control panel for WFI Generation system and PS is same. Purified water is converted to pure steam by exchanging the heat with the industrial steam in the heat exchanger.
[][]Then, the pure steam is supplied to the user point by opening the pneumatic valve PBV501. The capacity of steam generation is 250 Kg/hr.

Operating Procedure:

Starting of Pure steam generation:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Open the industrial steam inlet valve such that the pressure is within 3-4 bar.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Press Start on that screen
[][]Press User key. After that following screen will appear
[][]Press the “Parameter setting**” button to set the parameters. Following screen will appear:
[][]Give user ID and Password and press OK.
[][]Then the parameter setting screen will appear.
[][]Press on any reading (yellow marked) to change the value if required.
[][]Then press flow chart status on Figure V.
[][]Screen of WFI/PS generation flow chart will appear.
[][]Press the Auto On button to operate the plant automatically.

[][]Open the pneumatic valve PBV501 when the temperature of pure steam reaches the required temperature limit.

During operation:

[][]Check PS temperature.
[][]Check Pure Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if it is found.
[][]The Operational Log Sheet (Annexure – I) of PS generation will be filled up by the operator on hourly basis.

Stopping procedure:

[][]Close the PS valve (PBV501).
[][]Press the Auto Off to stop the plant.
[][]Then switch the power off by turning the circuit breaker to off position.
[][]Close the industrial steam inlet valve.

Annexure:

Annexure – I: Operational Log Sheet of pure steam generation system.

Boiler, Purpose:

Boiler, The purpose of this SOP is to define the standard operation and maintenance procedure of Boiler in order to ensure its smooth & trouble-free operation and generation of steam.

Boiler, Scope:

This SOP is applicable to Cochran Diesel / Gas Boiler which is located at the ground floor of Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Boiler: A boiler is a closed vessel in which water is heated; steam is generated and superheated from any combination of heat from combustible fuels or electricity.
[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]TDS: Total Dissolved Solids.

Responsibilities:

[][]The roles and responsibilities are as follows:

Validation (Engineering) Department

[][]Preparing the SOP and revise it when necessary.

Engineering Department

[][]To provide necessary support for smooth operation & maintenance of boiler.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the Boiler according to the SOP.
[][]To fill up the logbooks related to the Boiler.
[][]To do the maintenance according to the check list.

Manager, Engineering

[][]To ensure that the operation and maintenance of the Boiler.
[][]To approve any maintenance/plans related to the Boiler.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Ensure the control panel is switched off before carrying out any maintenance.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]No unauthorized person is allowed to do any kind of operation or maintenance to the boiler.
[][]The cover doors must be kept closed during operation.
[][]The safety mechanism of the machine must be checked by the operator for reliability in each and every working day.
[][]“Under Maintenance” be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Pre-start Check

[][]To ensure the permanent ventilation of the boiler house (Excluding doors and windows) is capable of supplying sufficient air for combustion and to keep the boiler house cool.
[][]Check all mechanical connections are properly tightened and have not worked loose in transit.
[][]Check direction of rotation of burner fan motor.
[][]To ensure oil / Gas is present.
[][]To ensure fuel / Gas valve is “OPEN”.
[][]To ensure water level in the feed water tank is enough.
[][]To ensure the burner switch on the control panel is OFF.
[][]To ensure feed water pump valve is “OPEN”
[][]To ensure that the fuel / Gas selector switch has selected OIL.
[][]To ensure that the gas isolating valves are closed and the oil isolating valves are open.
[][]The boiler feed pump should be filled with water on its suction side.
[][]The boiler should be filled with softened water.
[][]Ensure the fuel / Gas filters are clean.

Starting Procedure

[][]Main switch turn to “ON” position.
[][]Switch on the feed water pump selector switch (No.1 or No.2 for respective pump selection).
[][]Turn feed water pump control switch to “AUTO” position from “OFF” position.
[][]Turn burner control switch to “LOW” position from “OFF” position.
[][]When boiler steam pressure reaches up to (6.5-7) bar then turn burner control switch to “LOW” position from “OFF” position.

During Operation

[][]All boiler gaskets, valve stuffing boxes and valve gaskets are to be checked periodically during the boiler heat-up.
[][]The boiler pressure gauge should be observed during this heat-up period.
[][]Water analysis after every 12 hours of operation. If feed water is found to be hard any time, stop the boiler immediately. Drain the water from the service tank.
[][]Regenerate the softener and fill up the feed water tank then restart the boiler.
[][]Any excessive sound coming from motors or any moving part.
[][]All valves, joints, head-hole and manhole covers are leak tight.
[][]The water level is correct and steady.
[][]Steady steam pressure is maintained.
[][]Check Safety valve.
[][]Check fuel pressure.
[][] The Operational Log Sheet (Annexure – I) of boiler will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:

“This is a computer generated report. The format is as per the original approved form.”

Boiler Stopping Procedure

[][]Turn burner control switch to “OFF” position.
[][]Turn feed water pump control switch to “OFF” position.
[][]Fuel / Gas valve is off.
[][]In case of an emergency where immediate shutdown is necessary, the emergency stop push button should be pushed immediately.

Preventive Maintenance Planning

[][]During maintenance works the equipment must be electrically isolated. After performing maintenance works maintenance log book (as same as Annexure – II) has to be filled up by the operator. The schedule which follows must be applied at the Interval which occurs first.

Daily Maintenance

[][]Ensure that the fuel filters are clean.
[][]Check the water level.
[][]Clean the viewing glass
[][]Check the operating pressures.
[][]The boiler feed pump should be filled with water on its suction side.
[][]The boiler should be filled with softened water.
[][]Check the quality of feed water.
[][]Check the safety valve.

Weekly Maintenance

[][]Clean the flame sensor & viewing glasses.
[][]Check the water level is properly controlled.
[][]Check the low level & extra low level alarms by reducing the water level.

Monthly Maintenance

[][]Clean igniter assembly.
[][]Drain the feed water tank to remove the sediment.
[][]Clean the burner nozzle & ignition electrodes.
[][]Check oil / Gas leaks.

Quarterly Maintenance

[][]Clean electrical contacts of all relays & tighten loose connection if any.
[][]Check the water pump seal non-return valve.
[][]Check & clean the furnace if required.
[][]Service burner unit.
[][]Check door and furnace seals.
[][]Visual check of refractory’s.
[][]Check control panel.
[][]Set-up combustion.
[][]Check safety interlocks.
[][]Drain & clean the water service tank.
[][]Check the feed water pump.
[][]Check the seals of the feed water pump.
[][]Clean the blower fan blades

Half Yearly Maintenance

[][]Check the valves for leakages; lap them if found leakage.
[][]Lubricate the bearing of water pump.
[][]Check the sealing of Manhole, head holes & clean out door of smoke box.

Annually Maintenance

[][]Check the burner position, adjust if required.
[][]Clean the boiler tubes with brush.
[][]Clean the combustion chamber.
[][]Overhaul the valves.
[][]Check the door refractory for any damage, repair if necessary.
[][]Check the door seal to make sure that there is no gas leakage.
[][]Clean the water side of the boiler thoroughly.

Annexure:

Annexure – I: Operational Log sheet of Boiler.
Annexure – II: Maintenance Log sheet of Boiler.

Dehumidifier Operation and Maintenance, Purpose:

Dehumidifier Operation and Maintenance, The purpose of this SOP is to define the operation and maintenance procedure of dehumidifiers of HVAC systems of Sterile and Solid of XX Pharmaceuticals Ltd.

Dehumidifier Operation and Maintenance, Scope:

This Standard Operating Procedure applies to the dehumidifiers of HVAC system installed at Sterile and Solid Block of XX  Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]AHU: Air Handling Unit.

[][]Dehumidifier: A dehumidifier is an equipment of HVAC system which reduces the level of humidity in the air. This basic dehumidification process uses a special humidity absorbing material called a desiccant, which is exposed to the air to be conditioned.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operator

[][]To operate the system according to the SOP.
[][]To fill up the log sheets.

GM, Engineering

[][]To ensure that the system is operated properly.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Do not touch the steam line with bare hands.
[][]Perform any kind of maintenance after switching off electrical power and also after cooling of hot pipe line.
[][]Use personal protective equipment and clothing as necessary at the time of performing maintenance work.
[][]Put the “UNDER MAINTENANCE” tag on an easily visible place of the equipment before performing maintenance.

System Description

[][]In an HVAC system a dehumidifier is used to reduce the humidity of air. There are various ways to dehumidify the air. Desiccant type dehumidifier is commonly used in HVAC system of pharmaceutical industry.
[][]A chemical (normally silica gel) is used as a desiccant which adsorbs the moisture in the air. The air to be conditioned is passed through the bed of silica gel which adsorbs the moisture.
[][]This silica gel is again regenerated using the heated air. The heated air is produced by using steam in the heat exchanger or by electrical heater.

Pre-start check

[][]Check that the related AHU of the dehumidifier is switched on.
[][]The steam pressure in the steam header should be between 2 to 4 bar.

Starting Procedure

[][]Switch on the main circuit breaker.
[][]Check the power indicating light.
[][]Turn the selector switch to “MANUAL” mode to run the dehumidifier using manual mode. “AUTO” position is selected to run the dehumidifier in automatic mode.

During Operation

[][]During operation, the indicating light “OPERATION” becomes on.
[][]Check the rotational direction of motor and bed of silica gel. It should be in clockwise direction.
[][]Check if there is any alarm in the alarm indicator and resolve it.

Stopping Procedure

[][]Turn the selector switch to off (O) position to switch off the dehumidifier.
[][]Switch off the main circuit breaker.

Preventive Maintenance of Dehumidifier

[][]Perform any kind of maintenance after switching off the electrical power and cooling of electrical heater.
[][]Fill up the log book after performing preventive maintenance (according to Annexure – I and Annexure – II).
[][]Perform preventive maintenance according to the following schedule:

Monthly

[][]Check the filters and clean if necessary.

Half yearly

[][]Check the rotor drive and clean with compressed air if it is necessary.
[][]Check that the rotor sealing is in the right position and not damaged.

Yearly

[][]Check the rotor bearing.
[][]Check the rotor surface.
[][]Check the motors for any abnormal sound.

After 3 years

[][]Change the silica gel.

Annexure:

Annexure – I: Log sheet for preventive maintenance of Dehumidifier

Chilled Water Circulating Pumps , Purpose:

Chilled Water Circulating Pumps , The purpose of this SOP is to define the operating procedure of chilled water and cooling water circulating pumps of HVAC system of XX Pharmaceuticals Ltd.

Chilled Water Circulating Pumps , Scope:

This Standard Operating Procedure applies to the chilled and cooling water circulating pumps installed at the roof top area of Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:
VSD: Variable Speed Driver.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.
[][]Engineering (Maintenance) Department
[][]To provide necessary support for smooth operation of the system.

Operator

[][]To operate the system according to the SOP.

Manager, Engineering

[][]To ensure that the system is operated properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Annexure:

N/A

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant.
[][]In HVAC system, chilled water is used to cool the air inside the AHUs. This chilled water is produced in chiller and circulated from chiller to heat exchanger of AHUs through pumps. This acts as a closed loop.
[][]In cooling tower, the cooling water is circulated from cooling tower to the condenser of chiller through pumps.

Pre-start check

[][]Ensure that pipeline is filled with water. If there is not sufficient water, the pump may be damaged.

Starting Procedure

For VSD
[][]Switch on main circuit breaker to give electrical power to VSD.
[][]Press the  “HAND” button and then press the Green button on VSD to start the pumps.

[][]Press the green button to start the pump. During operation check for any alarm (RED indicating light)
#Stopping Procedure
#For VSD
[][]Switch off the pump by pressing the red button on VSD.
[][]Switch off the main circuit breaker.
[][]For Star Delta connection
[][]Press the RED button to switch OFF the pump.
[][]Switch off the main circuit breaker.

Cooling Tower , Purpose

Cooling Tower , The purpose of this SOP is to define the operation and maintenance procedure of Cooling Towers of XX Pharmaceuticals Ltd.

Cooling Tower , Scope

This SOP applies to the cooling towers, installed at the roof top area of Solid and Sterile Blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of cooling towers.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.
[][]To engage technician/mechanic/operator/supplier in repair and maintenance work.

Operators/Technician

[][]To operate the cooling tower according to the SOP.
[][]To do the maintenance job according to the schedule.

Head of Engineering

[][]To ensure that the operation and maintenance of cooling towers are done properly.
[][]To approve any maintenance plans related to the cooling towers.

Head of Quality Assurance

[][]To approve this SOP
[][]To ensure overall implementation of this SOP.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant.

Specific attention must be paid to the following:

[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]“Under Maintenance” tag be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Pre-Start Check

[][]Inspect all wiring connections to be sure they are clean and tight.
[][]Check the power supply voltage within the utilization range.
[][]Check cooling Tower basin water level.
[][]Check the fused-disconnect switch(es) that supplies power to the condenser water pump starter.
[][]Start Condenser water pump.
[][]Start the cooling tower fan.
[][]Check all piping for leakage.
[][]Check the condense water valve are “OPEN”.
[][]Visually inspect the condenser water pressure.
[][]Check condense water modulating butterfly valve position.
[][]Check the condense water line make-up water tank water level.

[][]Starting procedure
[][]Power ON for VSD.
[][]Press “Hand” Button.
[][]Press Start Button.

Stopping Procedure

[][]Press the Stop (Red) button.(See Figure-I)
[][]Power off for VSD.

Preventive Maintenance schedule

[][]Use of a periodic maintenance program is important to ensure the best possible unit performance and efficiency. Fill up the Annexure – I and II after completing the maintenance tasks accordingly.

Daily Maintenance

[][]Check the condense water pressure,
[][]Check cooling towers basin water level.
[][]Clean the cooling towers outside and surroundings.

Weekly Maintenance

[][]Current drawn by the fan motor.
[][]Check cooling tower fan rotation.
[][]Unusual noise, vibration, and so forth.

Monthly Maintenance

[][]Check and clean strainer.
[][]Clean Fan blade.
[][]Check the Belt tension.
[][]Clean the Internal side of the cooling Tower.
[][]Check and adjust sump water level.
[][]Check and adjust blow-down.
[][]Inspect water distribution.
[][]Clean the cooling towers Fins.
[][]Change the cooling water, refill with chemical.
[][]Grease the cooling tower motor.
[][]Clean the Y-strainer of chilled water and condenser water line.

Annually Maintenance

[][]Check/clean all parts of cooling tower.
[][]Clean cooling tower basin.
[][]Clean cooling tower fins.
[][]Check setting and operation of all controls and safety devices.
[][]Check starter contactors for wear and replace if required.
[][]Check motor winding insulation.
[][]Check motor amps draw.
[][]Check and adjust the water flow.
[][]Change the water of chilled water line.

Annexure

Annexure-I: Maintenance Log sheet of Cooling Tower

HVAC System Filters Numbering, Purpose:

HVAC System Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of terminals/filters of HVAC system of XX Pharmaceuticals Limited.

HVAC System Filters Numbering, Scope:

All types of filters, diffusers and return risers/grilles of HVAC system of both Solid and Sterile Blocks are covered by this SOP.

Definitions / Abbreviation:

[][]HVAC: Heating Ventilation and Air Conditioning.
[][]HEPA: High Efficiency Particulate Air.
[][]AHU: Air Handling Unit.

Responsibilities:

[][]The roles and responsibility are as follows:

Engineering Person(related to HVAC)

[][]To fill up the request form (Annexure – 1) to get the ID of newly fitted filters/diffusers/return grilles.
[][]To inform validation (engineering) department if there is any replacement of terminals/filters.

Engineering (Validation) Department

[][]To give the ID of filters/diffusers/return grilles.
[][]To maintain a register for terminals/filters of HVAC system.

Functional Head

[][]To ensure that all the terminals/filters of HVAC system are numbered according to this SOP and any inclusion or exclusion is reported to the Validation (Engineering) department.

Head of Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

[][]Supply Diffuser and Filter Numbering
[][]Filters will be numbered using the following convention:
[][]AAAA – BBBB – CCC – XXX
Where,
[][]AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant.
[][]BBB/BB/B: 3/2/1 characters to indicate the diffuser and filter.
[][]For a diffuser and filter combination the code will be ‘DF’. If there is a swirl diffuser and filter, the character will be ‘SDF’.
[][]For a supply terminal without filter, the code will be only ‘D’ for diffuser. Only ‘F’ is used for the filters inside the AHUs.
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter.
[][] First 2/3 characters indicate the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]The character will be 000 in case of having no filter with the supply diffuser.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter in an area.
For an example, a terminal flat type HEPA filter of grade H13 of Production Area of Sterile Block will be numbered according to the following way:

SPRD – DF – H13F – 001

001=Sequential Number for that area

H13F=H13 Grade and Flat type filter.

DF =Diffuser and Filter

SPRD=Sterile Production Area

Return Grille/Riser, Filter and Exhaust Grille Numbering

[][]All diffusers and return grilles of HVAC system of the plant will be numbered using the following convention:
AAAA – BBB – CCC – XXX
Where,
AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant.
[][]BBB: 3 characters of which first 2 characters indicate either low return riser or high return.

[][]Last character indicates filter or grille. ‘RR’ or ‘HR’ is used to indicate the low return riser and ceiling return respectively. ‘

[][]F’ and ‘G’ is be used for last character to indicate the filter and grille correspondingly. For exhaust grille the code will be 2 letters ‘EG’.
[][]CCC: 3 characters to indicate the filter grade and type of filter.

[][]If there is no filter in the return, the character will be 000.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of terminals/filters of a particular area.
[][]For an example, a low return riser of production area of general block with a G4 bag type filter is identified according to the following way:

PRD – RRF – G4B – 001

001=Sequential Number.

G4B=Filter grade and type

RRF =Low return riser with filter

PRD=Solid Block Production Area

[][]All terminals/filters of HVAC system will be tagged containing ID number. Format of filter identification tag is as follows:

[][]ID Number##

[][]The length and height of the box is 4.0 inch and 0.4 inch respectively. Arial font of size 10 shall be used for all the letters.
[][]A register of Terminal/Filter ID will be reserved in the validation (Engineering) department. (See Annexure – III).

[][]To get the ID of newly installed filters/terminals, the request form for ID (Annexure – II) will be filled up by the respective engineers and sent to the validation (engineering) department. Validation department will provide the sticker of ID and photocopy of the request form after giving new ID.
[][]If a Terminal/Filter is replaced with a new one, the new ID no. will be provided and the previous ID no. will not be used again.
[][]If any filter of new grade (which is not listed in the Annexure – I) is installed, the new filter will be added in the Annexure – I by handwriting of Head of QA with signature and date without reviewing the whole SOP. The Annexure – I will be added on the next version of this SOP.
[][]Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easier to handle, the exact format of the approved form can be used (except the approval sign) with the following notes as footer:

[][]“This is a computer generated report. The format is as per the original approved form”

Annexure:

Annexure-I : Code for Grade and Type of Filters.
Annexure-II : Request Form for ID Number of New Terminal/Filter of HVAC system.
Annexure-III : Register of Terminal/Filter of HVAC system.

Purified Water System Sanitization, Purpose:

Purified Water System Sanitization , The purpose of this SOP is to define the sanitization procedure of purified water distribution system in automatic mode.

Scope:

Purified Water System Sanitization , This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both Solid and Sterile Blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PQ: Performance Qualification.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.
[][]To inform PW user departments not to open the valves during sanitization.

Operators

[][]To operate the system according to the SOP.
[][]To fill up the logbooks.

Head of Engineering

[][]To ensure that the operation of PW plant are done properly.

Head of Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:

[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 40% water level in the PW storage tank before starting sanitization.

System Description:

[][]There are two distribution systems of purified water in cephalosporin and general block. There is a shell and tube type heat exchanger in distribution loop to sanitize the system.
[][]During sanitization, purified water is heated using industrial steam at a temperature of 80–90⁰C. Then, this hot water is circulated through distribution loop for a period of 60 minutes.
[][]Cooling is done after sanitization at a temperature of 40⁰C using chilled water.

Sanitization Procedure:

Prestart check:

[][]Ensure minimum 3 bar industrial steam pressure before starting sanitization.
[][]Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line and inform all the PW user departments not to open the valve during sanitization period
[][]Check the water level in the PW storage tank. It has to be minimum 40%.

Starting of Sanitization system in automatic mode:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Then the following screen will appear. Press “Control flow”.

[][]Press the “Sanitization OFF” and give user ID and password.

[][]Press the “Sanitization OFF” again to start the system in automatic mode.

During Sanitization:

[][]During sanitization PW is circulated through the distribution line at a temperature of 80–90⁰C. After cooling the sanitization will be automatically stopped when the water temperature decreases to 40⁰C.
[][]Fill up the log sheet (Annexure – I) at 30 minutes interval after starting the cycle of sanitization.

Sanitization Frequency:

[][]After successful completion of chemical and microbiological tests of PQ (phase-1, phase-2 and phase-3 study) of PW system, the sanitization frequency has been finalized to 14 days interval.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.
[][]The distribution loop of General Block will either be sanitized prior to cephalosporin block’s loop or will be sanitized both at a time.

Annexure:

Annexure – I: Operational Log Sheet of Sanitization of PW distribution system

Purified Water Generation Plant, Purpose:

Purified Water Generation Plant, The purpose of this SOP is to define the Manual Operation of Purified Water Generation Plant manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Purified Water Generation Plant, Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, which is located at the Utility area (roof top) of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]RO: Reverse Osmosis.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.

Operators

[][]To operate the PW plant according to the SOP.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

Operating Procedure:

[][]Manual operation of PW plant:
[][]Starting of PW plant:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Enter on that screen.
[][]Then the following screen will appear.
[][]Press “Parameter setting**” button to check the parameters and a box will appear for user ID and Password.
[][]Then the following screen will appear to see the parameters. Press “setting2” to see the other parameter settings.
[][]Then the following screen will appear.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Manual off” button. In Manual mode the Multi Grade Filter and Active Carbon Filter will be reversely washed and then the RO will be washed by manually on Valve and pump. The softener generation also will be done manually.
[][]Reverse Washing of Multi grade filter:
[][]Active carbon filter reverse washing:
[][]Softener Regeneration:
[][]Manual Operation In RO:
[][]Press on RO Flow chart on Screen and will show following screen
[][]After 5-10 min on pump PU51-01,PU51-02,PU52
[][]Do reverse washing as it is stated for 3 minutes.
[][]Then open the valves XV51-09, XV51-06, XV52-10, XV52-09, XV52-06 and XV60-01.
[][]During Operation:
[][]To see any alarm press the “Alarm status” button in Figure 05. Following screen will appear:
[][]By pressing the button “ ” the alarms will be acknowledged and stored in the alarm history. All the alarms in the alarm history can be watched in the “History Alarm” section by pressing the Up and Down arrow.
[][]There is an online data logger which logs the conductivity of water after softener, 1st RO, 2nd RO and EDI.
[][]The real time curve can be seen by pressing the “Real Time Curve” button in Figure 05.

Stopping procedure of PW plant:

[][]To Stop Pump PU51-01,PU51-02,PU52
[][]To stop valves.
[][]After that press “Manual on” button in the “Pretreatment Flowchart status” screen (Figure 05) for stopping manual mode.
[][]Switch off the main breaker to cut the electricity.
[][]Close the line of compressed air and other utilities.

Annexure:

N/A

Purified Water Generation, Purpose:

Purified Water Generation, The purpose of this SOP is to define the Maintenance procedure of Purified Water Generation and Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Purified Water Generation, Scope:

This Standard Operating Procedure applies to the PW Generation and Distribution systems manufactured by Watertown. The Generation system of purified water is located at the utility area (roof top).

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]RO: Reverse Osmosis.
[][]EDI: Electro De Ionizer.
[][]ACF: Activated Carbon Filter.
[][]MGF: Multi Grade Filter.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for maintenance of the system.
[][]To ensure that the operators are responsible to carry out the maintenance tasks and fill up the logbooks.

Operators

[][]To perform the maintenance of the system according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the maintenance of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Hang the Maintenance tag prior to any maintenance activity.

System Description:

[][]The PW is produced from feed water through various processes. In pretreatment portion the feed water is passed through the MGF, ACF, softener and 5 micron cartridge filter. Then the pretreated water is passed through 1st and 2nd stage RO and finally through EDI. In RD/EDI section there is another 5 micron cartridge filter after 1st RO.

[][] There are four chemical dosing systems in PW Generation system such as chlorine dosing, SMBS dosing, Anti Scalant dosing and pH correction dosing. There is a PW storage tank of capacity 5000L in Solid Block.

[][]Also, there is a PW Distribution loop in the Liquid Block which contains a 3000L PW storage tank. There is a user point in the PW distribution loop system of Solid to supply the PW in the PW storage tank of Liquid Block.

Maintenance Procedure:

[][]Filter Cleaning procedure: The cartridge filter is cleaned when the filter is blocked and the pressure rises. Normally, an alarm is generated on the PLC due to high pressure (greater than 0.3MPa).
The cartridge filter is dismantled from the filter housing. Then wash the filter by passing the normal water through the filter in backward direction.
[][]Sanitize the ACF after every 14 days according to the SOP.
[][]Sanitize the 1st RO, 2nd RO and EDI after 6 months according to the SOP.
[][]Sanitize the PW distribution system after every 14 days according to the SOP.
[][]Clean the dosing tanks on every 2 weeks. At first, empty the dosing tank and wash it by PW.
[][]The maintenance schedule of PW Generation and Distribution system is given below:

[][]Daily maintenance
>>Check for any leakage.
[][]Bi monthly
>>Clean the dosing tanks.
[][]Monthly
>>Shoot clean for panel board.
[][]Yearly
>>Tighten all the nuts and bolts.
>>Check all electrical connections.
[][]After two years
>>Change the gasket of the valves.
>>Check the pneumatic pipes and change if it is necessary.
>>High pressure (greater than 0.3 MPa) across the cartridge pre filter
>>Wash the cartridge pre filter.

Annexure:

Annexure – I: Maintenance Log Sheet of PW Generation and Distribution system

Purified Water Distribution System , Purpose:

Purified Water Distribution , The purpose of this SOP is to define the Operation of Purified Water Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Purified Water Distribution, Scope:

This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both General and Cephalosporin Blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To operate the system according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

Both the Generation and Distribution system of PW plant has been installed by Watertown. In PW distribution system purified water is circulated by a booster pump. There are a flow transmitter and a conductivity transmitter in the return line of PW which show the flow rate and conductivity of PW. The system can be operated using both the manual and automatic mode.

Operating Procedure:

[][]Automatic operation of PW Distribution system:

Starting of PW Distribution system:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Automatic Cycle OFF” and give user ID and password.
[][]Press the “Automatic Cycle OFF” again to start the system in automatic mode. When the system is started, the “Automatic Cycle OFF” turns into “Automatic Cycle ON” and the booster pump becomes ON.

During Operation:

[][]To see any alarm press the “Alarm” in Figure 02.
[][]By pressing the “ ” the alarms will be acknowledged and stored in the alarm history.
[][]Press the “Parameters Set” to see and change the set parameter.
[][]The Daily Operational Log Sheet (Annexure – I and II) of PW distribution system will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping of PW distribution system:

[][]Press the “Automatic Cycle ON” of on HMI. The booster pump will shut down.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency press the emergency switch.

Manual operation of PW distribution system:

[][]Starting of PW distribution system:
[][]Follow the steps of one to five of section
[][]Press the “Manual Cycle OFF” and give user ID and password on HMI (figure 02). Again press the “Manual Cycle OFF” and it turns to “Manual Cycle ON”.
[][]Switch ON the booster pump, pneumatic valves of vent filter and return line by pressing the ON button of each component on HMI.

Stopping procedure of PW distribution system:

[][]Switch off the booster pump and pneumatic valves of vent filter and return line.
[][]Press the “Manual Cycle ON”.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency, press the emergency switch.

Annexure:

Annexure – I: Operational Log Sheet of PW Distribution system

Reverse Washing, Purpose:

Reverse Washing, The purpose of this SOP is to define the Reverse washing of MGF, ACF and regeneration of softener of PW Generation system in manual mode.

Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, which is located at the Utility area (roof top) of General Block of Labaid Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]MGF: Multi Grade Filter.
[][]ACF: Active Carbon Filter.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation)

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.

Operators

[][]To operate the PW plant according to the SOP.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

Operating Procedure:

Manual Reverse Washing of MGF:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Enter on that screen.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Manual off” button and give USER ID and Password.
[][]On Valve by pressing on Valve position on screen (figure-05) XV44-04, XV44-05, and XV20-02.
[][]Set frequency (0-50Hz) PU30B/PU30A.
[][]ON Pump by pressing on pump position.
[][]After 5-10 min off the pump by pressing on pump position.
[][]On valve by pressing on valve position on screen XV44-01, XV44-03.
[][]Pump ON.
[][]Reverse washing of MGF is performed for 10 minutes. Depositing and observe washing of MGF is performed for 2 minutes and 5 minutes respectively.

Active Carbon Filter Reverse Washing:

[][]OFF Valve XV44-03
[][]ON Valve XV44-02
[][]ON Valve XV45-04,XV45-05
[][]After 5-10 min Pump off.
[][]On Valve XV45-01,XV45-03
[][]After 0-10 min OFF valve XV45-03
[][]On Valve XV45-02
[][]After 5-10 min will go to softener operation.
[][]The time for reverse washing, depositing and observe washing is as same as MGF.

Softener Regeneration:

[][]For back washing of softener A ON the valve XV50-04A and XV50-05A. Backwashing will be performed for 10 minutes.
[][]After backwashing during regeneration ON the valves XV50-01A, XV50-15, XV50-14A, XV50-03A. Regeneration will be performed for 50 minutes.
[][]For observe washing ON the valves XV50-01A, XV50-03A. Observe washing will be performed for 50 minutes.
[][]Backwashing, regeneration and observe washing procedure of softener B is same as softener B.

Reverse Washing of RO:

[][]Press on RO Flow chart on Screen and will show following screen
[][]After 5-10 min on pump PU51-01,PU51-02,PU52
[][]On valve XV51-07, XV51-05, XV52-06, XV52-07 and XV52-05.

Annexure:

N/A

Purified Water Distribution System, Purpose:

Purified Water Distribution System, The purpose of this SOP is to define the sanitization procedure of purified water distribution system in manual mode.

Purified Water Distribution System, Scope:

This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of  XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation according to the SOP.
[][]To inform PW user departments not to open the valves during sanitization.

Operators

[][]To operate the system according to the SOP.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 35% water level in the PW storage tank before doing sanitization.

System Description:

[][]There are two distribution systems of purified water in cephalosporin and general block. There is a shell and tube type heat exchanger in distribution loop to sanitize the system. During sanitization, purified water is heated using industrial steam at a temperature of 80⁰C. Then this hot water is circulated through distribution loop for a period of 60 minutes. Cooling is done after sanitization at a temperature of 40⁰C using chilled water.

Sanitization Procedure:

Prestart check:

[][]Ensure minimum 3 bar industrial steam pressure before starting sanitization.
[][]Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line and inform all the PW user departments not to open the valve during sanitization period.
[][]Check the water level in the PW storage tank. It has to be minimum 35%.
[][]Open the steam inlet valve manually before starting sanitization

Starting of Sanitization system in manual mode:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press “ENTER” on HMI.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Manual Cycle OFF” and give user ID and password.
[][]Press the “Manual Cycle OFF” again to start the system in manual mode.
[][]Open the vent valve and PW inlet valve of storage tank and switch ON the distribution pump by pressing the ON button on HMI.
[][]Open the pneumatic valve of steam inlet and condensate outlet of heat exchanger. See the next figure:

#Open the valves and start the pump

#Open the valves to start sanitization.

[][]Press the “Sanitization OFF” button to start the sanitization.
[][]Wait until the temperature of PW increases up to 80⁰C. When the temperature reaches at 80⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the PW through the distribution loop for an hour.

[][]Cool down the temperature of PW less than 40 deg.C. Fill up the log sheet during sanitization on every 30 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.
[][]Sanitization Frequency:
[][]Initially, the sanitization will be performed after every 20 days.
[][]Sanitization frequency will be finally determined after completion of phase – 3 of performance qualification of PW.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

WFI generation system operation, Purpose

WFI generation system operation, The purpose of this procedure is to provide directions for operating the WFI generation System.

WFI generation system operation, Scope

This SOP applies to the WFI generation system which is located at the roof top area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]HMI: Human Machine Interface

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators/Technician

[][]To operate the WFI generation system according to the SOP.
[][]To fill up the logbooks related to the PW plant.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure

Precautions:

[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burns.
[][]The piping system is under pressure .Causing an open in the systems pressurized piping without taking suitable precaution may release medium pressure (60+psig).
[][]Running the pump without water in it will burn out the motor after only a few seconds, and it may cause the pump to seize as well.

Operation of WFI generation Plant

[][]Starting Procedure of WFI Generation System:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Start on that screen.
[][]Press User key. After that following screen will appear
[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show the following screen.

Automatic Operation:

[][]After parameter setting, Back to previous screen and Press on “flow chart status”. If there is no need to parameter setting avoid the procedure.After pressing the flow chart status key following figure will be shown below. After that Press on the “Auto” for on the system in automatic operation.

Manual operation:

After parameter setting, Back to previous screen and Press on “Flowchart Status” for ON the system for manual operation. If there is no need to parameter setting avoids the procedure. After pressing the flowchart status key figure-III will be shown. If the system is on in Automatic mode must off the system. Press on the “Manual” for on the system in manual mode. After that ON Pump (PU01), ON valve PASV501, PASV201, and PDMV402.Other controlling Valve operate Operator according to the condition of the system.

Check during operation

[][]Check WFI Temperature.
[][]Check Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI generation system will be filled up by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

[][]Stopping Procedure of WFI distribution System

Automatic Operation:

[][]if plant is running on Automatic mode then stops the system by pressing on the key Auto. Then power off by turning to off position in circuit breaker.

Manual Operation:

[][]At first turn off the pump. After that stop valve PASV50, PASV201, and PDMV402. The system stop by pressing on the key Manual. Then power off by turning to off position in circuit breaker.

Annexure

Annexure-I: Operational Log sheet of WFI Generation System.

WFI distribution system, Purpose

WFI distribution system, The purpose of this procedure is to provide directions for operating the WFI Distribution System

WFI distribution system, Scope

This SOP applies to the WFI distribution system which is located at the roof top area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators/Technician

[][]To operate the WFI distribution system according to the SOP.
[][]To fill up the logbooks related to the PW plant.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure

Precautions:

[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burns.
[][]The piping system is under pressure. Causing an open in the systems pressurized piping without taking suitable precaution may release medium pressure (60+psig).
[][]Running the pump without water in it will burn out the motor after only a few seconds, and it may cause the pump to seize as well.
[][]There is one electrical panel for the distribution system. The PLC panel has 110V power in it. Precautions should be taken to avoid contact with the 110V power line. The remainder of the panel is at 24V.
[][]The panel inside is installed a VFD. It has an external power. It is unsafe to open the panel with power (415V) ON. Only knowledgeable service technicians should operate the VFD.

System Description

[][]Distribution skid and distribution piping will contribute to WFI distribution system.
[][]Distribution skid
[][]Distribution pump, system, sampling valves, instruments and control panel will be mounted on skid. The skid frame is constructed from 304 grade stainless steel.

Pump:

[][]Pump will be designed and selected according to cGMP requirement for velocity, flow and contact parts. Pressure gauge at the discharge will monitor the pressure.

Three way Pneumatic valve:

[][]Flow diverter valves are provided at the supply line and return line of distribution system. If conductivity of water is greater than the set point of conductivity transmitter provided at supply & return line of distribution system, drain port of this valve will open and in turn will not allow quality deteriorated water to go to the point of use & to the system.

Distribution Piping

[][]The whole distribution system is fabricated and installed as per cGMP. Distribution system is fabricated out of SS316L tubes and tube fittings (sanitary type). The distribution loop consists of 5 user points. The user point valves are zero dead leg valves. Orifice plates are provided at each point of use to maintain specific flow. The return line of distribution system is connected back to the top of the storage tank with the spray ball provided inside the tank.

Operation of WFI Plant

[][]Starting Procedure of WFI Distribution System:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.

[][]The HMI becomes ON and screen will appear.

[][]Over the window Touch this[ENTER] key

[][]Press Enter on that screen . After that a screen will appear

[][]Over the screen Press on “Parameter set” for Parameter Set.

[][]Press on “Alarm” for Alarm check

[][]Press on “Control Flow” for ON the system

[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show a screen.

[][]Press on BACK for return of the previous screen

Automatic Operation:

[][]After parameter setting, Back to previous screen and Press on “Control Flow”. If there is no need to parameter setting avoid the above procedure .After pressing the Control Flow key a screen will appear.

Two option will show the screen

1.0 “Automatic Cycle”

2.0 Press on “Manual cycle”

[][]Press on the “Automatic cycle” for on the system in automatic operation.

Manual operation:

[][]After parameter setting, Back to previous screen and Press on “Control Flow” for ON the system for manual operation. If there is no need to parameter setting avoids the above procedure  . After pressing the ‘Control Flow’  will be shown. If the system is on in Automatic mode must off the system. Press on the Manual cycle for on the system in manual mode. After that ON Pump (PU300), ON WFI inlet valve in WFI tank.

Check during operation

[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI distribution system will be filled up by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure of WFI distribution System

[][]Automatic Operation: if plant is running on Atomatic mode then stops the system by pressing on the key Automatic cycle. Then power off by turning to off position in circuit breaker.
[][]Manual Operation: At first turn off the circulating pump and WFI inlet valve from distribution loop. After that stops the system by pressing on the key Manual cycle. Then power off by turning to off position in circuit breaker.

Annexure

Annexure I Operational log Sheet of WFI Distribution System

WFI Generation and Distribution, Purpose:

WFI Generation and Distribution, The purpose of this SOP is to define the Maintenance of WFI Generation & Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation.

WFI Generation and Distribution, Scope:

This Standard Operating Procedure applies to the WFI Generation & Distribution system manufactured by Watertown, which is located at the Utility area (roof top) of Cephalosporin Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure
[][]WFI: Water For Injection
[][]HMI: Human Machine Interface
[][]PTFE: Poly Tetra Fluro Ethin

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth maintenance of the system.
[][]To ensure that the operators are responsible to carry out the maintenance and fill up the logbook.

Operators/Technician

[][]To perform maintenance of the system according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the maintenance of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:

[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.

Maintenance Schedule:

[][]The maintenance schedule of WFI generation and distribution system is given below:

Daily maintenance

[][]Check for any leakage in steam line or WFI line.

After 800 hrs.

[][]Check and clean the filter/strainer.
[][]Check and clean the steam traps.
[][]Check the safety valve.
[][]Clean the storage tanks.

After 8000 hrs.

[][]Check the PTFE gaskets on the membrane valve and replace it if necessary.
[][]Check the diaphragm valves and change the diaphragm if it is necessary.
[][]Check the gaskets of heat exchangers.
[][]Check the mechanical seals of pump.
[][]Change the vent filter cartridge.

Annexure:

Annexure – I: Maintenance Log Sheet of WFI Generation and Distribution system 

ETP Operation, Purpose:

ETP Operation, The purpose of this SOP is to define the standard operating procedure of Effluent Treatment Plant of XX Pharmaceuticals Ltd.

ETP Operation, Scope:

This Standard Operating Procedure applies to the Effluent Treatment Plant of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]ETP: Effluent Treatment Plant.
[][]PPE: Personal Protective Equipment.
[][]PAC: Poly Aluminum Chloride.
[][]MGF: Multi Grade Filter.
[][]ACF: Activated Carbon Filter.

Responsibilities:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and regular checking of the critical components.

Operators

[][]To operate the ETP according to this SOP.

Manager, Engineering

[][]To ensure that the operation of ETP are done properly.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Handle the chemicals by wearing PPE.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]The capacity of ETP is 12000 Ltr/hr. The effluents from the Solid and Liquid block come into the neutralization and equalization tanks respectively via bar screen chambers. In the bar screen chamber the floating material or solid material is filtered. A dosing of lime is provided in the neutralization tank if pH correction is needed.

[][]Also, the effluents are aerated in these tanks with air which is provided by the blowers. After being neutralized in the neutralization tank the effluents goes to equalization tank and then the effluent is transferred to flocculation tank through effluent transfer pumps.
[][]A dosing of PAC is provided in flocculation tank to flocculate all the effluents. Poly electrolyte dosing is provided in the transferring pipe of effluents from flocculation tank to lamella. After lamella the effluent is passed to the aeration tank.
[][]In aeration tank the effluents are aerated with air. A dosing of NaOH is provided if it is necessary. There is a buffer tank after aeration tank where one kg of urea will be provided after every 3 months of operation.
[][]There is a line under the buffer tank to transfer the sludge to underground sludge tank and then to sludge pit by sludge transfer pump.
[][]Clear water from buffer tank is stored in the clear water tank. There are two pumps to transfer the clear water to final storage tank through MGF and ACF. One pump is used at a time.

Operating Procedure:

Starting of ETP:

[][]Perform backwash of Multi Grade Filter for 15 minutes and Active Carbon Filter for 15 minutes daily before starting the plant by clean water.
[][]Switch ON the main breaker.
[][]Switch On the Blower A/B, effluent transfer pump 1/2 (alternative), Clean water transfer pump 1/2 (alternate) and keep the position of each switch in Auto mode. The dosing pumps of lime, PAC and polyelectrolyte are synchronized with the effluent transfer pumps. When the effluent transfer pumps are switched on those dosing pumps are started and vice versa. The dosing pump of NaOH is started manually when necessary.
[][]There are two float switches in the equalization and clear water tanks. When the equalization tank level will be high the effluent transfer pump will be switched on automatically and effluents will be transferred to flocculation tank.
[][]At that time, the Polyelectrolyte, PAC and lime dosing will be started automatically. If the equalization tank level becomes low, the pump will be switched off automatically.
[][]If the clean water tank level becomes high, the clean water transfer pump will be switched on and effluent transfer pump will be switched off automatically. When the level of clean water tank becomes low the clean water transfer pump will be switched off and effluent transfer pump will be switched on automatically.
[][]The effluent is transferred from flocculation tank to clear water tank via lamella, aeration tank and buffer tank by overflow of each tank.
[][]The blowers are changed over automatically after 10 minutes of operation if the main switch remains in Auto position.
[][]After 8 days of operation switch ON the sludge transfer pump to transfer the sludge to the sludge pit.

During operation:

[][]During operation fill up the operational log sheet (Annexure – I) on every hour.
[][]Check the dosing tank level.

Stopping procedure:

[][]Switch OFF the effluent transfer pumps and blowers.
[][]Switch OFF the clear water transfer pumps.
[][]Switch OFF the dosing pumps.

Annexure:

Annexure – I: Daily Operational Log Sheet of ETP.

WFI Distribution, Purpose:

WFI Distribution, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in automatic mode.

WFI Distribution, Scope:

This Standard Operating Procedure applies to the WFI Distribution system manufactured by Watertown, China located at the Utility area  of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]HMI: Human Machine Interface.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.
[][]To inform WFI user departments not to open the valves during sterilization.

Operators

[][]To operate the system according to the SOP.
[][]To fill up the logbooks properly.

Manager, Engineering

[][]To ensure that the operation of WFI plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.

[][]Inform the respective departments i.e. Production, Microbiology, Quality Control not to open any valve of distribution line during sterilization.
[][]Ensure at least 40% water level is present in the WFI storage tank before doing sterilization.

System Description:

[][]The WFI distribution system is sterilized at a temperature of 121⁰C. WFI is heated up by using industrial steam. Heated WFI is circulated for 1 hour. After completing the sterilization distribution line is cooled down. The cooling temperature is 90⁰C. Chilled water is used to cool the WFI.

Sterilization Procedure:

Prestart check:
[][]Ensure minimum 3 bar industrial steam pressure before starting sterilization.
[][] Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line.
[][]Starting of Sterilization system in automatic mode:
[][]Open the steam inlet valve manually before starting sterilization.
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press ENTER on HMI.
[][]Then a page will be displayed on HMI and press “Control flow”.
[][]Press the “Sanitization OFF” and give user ID and password.
[][]Press the “Sanitization OFF” again to start the system in automatic mode.

During Sterilization:

[][]During sterilization WFI is circulated through the distribution line at minimum 121oC.
[][]Fill up the log sheet (Annexure – I) during sterilization after every 20 minutes.
[][]Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:

“This is a computer generated report. The format is as per the original approved form.”

After Sterilization:

[][]Drain all the water from the user points.
[][]Fill up the WFI storage tank with fresh WFI by running WFI Generation system.

Sterilization Frequency:

[][]The sterilization of WFI loop will be performed every 30 days.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

Annexure – I: Operational Log Sheet of Sterilization of WFI distribution system.

Storage Tanks Cleaning, Purpose:

Storage Tanks Cleaning, The purpose of this SOP is to define the cleaning procedure of all the intermediate storage tanks and final storage tanks of PW and WFI generation and distribution systems of XX Pharmaceuticals Ltd.

Storage Tanks Cleaning, Scope:

This Standard Operating Procedure applies to the intermediate and final storage tanks of PW and WFI generation and distribution systems  of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]PW: Purified Water.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth cleaning of the tanks.
[][]To ensure that the operators are responsible to carry out the cleaning and fill up the logbook.

Operators/technician

[][]To perform cleaning of the system according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the cleaning procedure of all the storage tanks are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about handling of toxic chemicals.
[][]Be careful when climbing using a ladder to reach at the top of the tank.

Cleaning Procedure:

[][]The cleaning procedure of intermediate and final storage tanks of both PW and WFI generation and distribution systems are stated below:
[][]Open the tip of the tank about 2 hours before cleaning.
[][]Close the inlet valve of the tank.
[][]Open the discharge valve at the bottom of the tank and make the tank empty.
[][]Wash the inside wall and ground floor of the tank with bleaching powder with the help of nylon brush.
[][]Spray fresh water into the wall thoroughly to remove dirt from the wall.
[][]Clean the level sensor of the tank.
[][]Drain out the dirty water.
[][]After successful completion of the cleaning procedure, dry inside of the tank.
[][]Storage tank is now ready for use.
[][]After cleaning of PW intermediate and final storage tanks record the cleaning in the Annexure – I. Also, for WFI storage tank record the cleaning in the Annexure – I
[][]The tanks will be cleaned after 800 hrs of operation of the plant.

Annexure:

N/A

WFI Distribution System Sterilization, Purpose:

WFI Distribution System Sterilization, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in manual mode.

WFI Distribution System Sterilization, Scope:

This Standard Operating Procedure applies to the WFI Distribution systems manufactured by Watertown, which is located at the Utility area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]HMI: Human Machine Interface.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation according to the SOP.
[][]To inform WFI user departments not to open the valves during sterilization.

Operators

[][]To operate the system according to the SOP.

Manager, Engineering

[][]To ensure that the operation of WFI plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Be careful about hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sterilization.
[][]Ensure at least 40% water level in the WFI storage tank before doing sterilization.

System Description:

[][]The WFI distribution system is sterilized at a temperature of 121⁰C. WFI is heated up by using industrial steam. Heated WFI is circulated for 1 hour. After completing the sterilization distribution line is cooled down. The cooling temperature is 90⁰C. Chilled water is used to cool the WFI.

Sterilization Procedure:

Prestart check:
[][]Ensure minimum 3 bar industrial steam pressure before starting sterilization.
[][] Chilled water temperature has to be less than 10⁰C.
[][] Close all the valves of distribution line and inform all the WFI user departments not to open the valve during sterilization period.
[][]Check the water level in the WFI storage tank. It has to be minimum 40%.
[][]Open the steam inlet valve manually before starting sterilization.

Starting of Sterilization system in manual mode:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press ENTER on HMI.
[][] Then a page will be displayed on HMI and press “Control flow”.
[][] Press the “Manual Cycle OFF” and give user ID and password.
[][]Press the “Manual Cycle OFF” again to start the system in manual mode.
[][]Open the vent valve and WFI return valve of storage tank and switch ON the distribution pump by pressing the ON button on HMI.
[][]Open the pneumatic valve of steam inlet and condensate drain valve.
[][]Press the “Sanitization OFF” button to start the sterilization.
[][]Wait until the temperature of WFI increases up to 121⁰C. When the temperature reaches at 121⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the WFI through the distribution loop for an hour.

Sterilization Period:

[][]During sterilization WFI is circulated through the distribution line at 121 ⁰C. If the temperature drops then open the steam inlet and condensate outlet valve to heat up the WFI.
[][]Fill up the log sheet (Annexure – I ) during sterilization every 20 minutes.

 Cooling Period:

[][]After completion of sterilization, switch OFF all the steam valves.
[][]Switch ON the pneumatic valves of cooling water in and cooling water out by pressing the ON button on HMI.
[][]Cool down the temperature of WFI less than 90 deg.C. Fill up the log sheet (Annexure – I ) during total sterilization period on every 20 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.

After Sterilization:

[][]Drain all the water from the user points.
[][]Fill up the WFI storage tank with fresh WFI by running WFI Generation system.

Sterilization Frequency:

[][]The sterilization of WFI loop will be performed every 30 days.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

N/A

HEPA Filters Numbering, Purpose:

HEPA Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of G4, F5, F7, F9 and HEPA filters of any machine (except HVAC system) of XX Pharmaceuticals Ltd.

HEPA Filters Numbering, Scope:

The G4, F5, F7, F9 and HEPA filters of any machine of all area of XX Pharmaceuticals Ltd are covered by this SOP.

Definitions / Abbreviation:

[][]N/A

Responsibilities:

[][]The roles and responsibility are as follows:

Engineering Person

[][]To fill up the request form (Annexure – 1) to get the ID of filters of newly installed machines.
[][]To inform validation (engineering) department if there is any replacement of filters.

Engineering (Validation) Department

[][]To give the ID of filters.

Functional Head

[][]To ensure that all the filters of machines are numbered according to this SOP and any Inclusion or Exclusion will be reported to the Validation (Engineering) department within 7 days of Inclusion/Exclusion.

Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Filter Numbering

[][]Filters will be numbered using the following convention:
AAAA – BBB – CCC – XXX
Where,
[][]AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant. (See the Annexure – I )
[][]BBB: 3 digits numerical code to indicate the machine. (See the Annexure – II)
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter (see Annexure – I). First 2/3 characters indicates the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter of that machine.
[][]For an example, a flat type HEPA filter of grade H14 of Dispensing booth of production area of Solid Block will be numbered according to the following way:

SPRD – 030 – H14F – 001

[][]001 =Sequential Number for that filter

[][]H14F=H14 Grade and Flat type HEPA filter.

[][]030=Numerical code of dispensing booth

[][]SPRD=Solid Production Area

[][]All G4, F5, F7, F9 and HEPA filters of Machines will be tagged containing ID number. Format of filter identification tag is as follows:

ID Number:

[][]The length and height of the box is 4.0 inch and 0.4 inch respectively. Arial font of size 10 shall be used for all the letters. A register ID numbers of filters will be maintained by the validation (Engg.) department.

[][]To get the ID of newly installed filters, the request form for ID (Annexure – II) will be filled up by the respective engineers and sent to the validation (engineering) department. Validation department will provide the sticker of ID and photocopy of the request form after giving new ID.

[][]If a Filter is replaced with a new one, the ID of previous one will be used for the new filter. For this, the respective engineering person will inform the validation (engineering) department and validation engineer will update the Filter list with the newly fitted one and replacement will be noted in the remarks section.

[][]If any filter of new grade (which is not in the list of Annexure – I) is installed, the Annexure – I will be updated by handwriting of Manager, QA with signature and date. The new grade filter will be added on the next version of SOP.

[][]Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easier to handle, the exact format of the approved form can be used (except the approval sign) with the following notes as footer:

“This is a computer generated report. The format is as per the original approved form”

Annexure:

Annexure-I : Code for Grade and Type of Filters.
Annexure-II : Request Form for ID Number of filters.
Annexure–III: Register of filters.

Gas Generator, Purpose:

Gas Generator, The purpose of this SOP is to define the operation and maintenance of the 1500 KW gas generator of XX Pharmaceuticals Ltd.

Gas Generator, Scope:

This SOP applies to the Cummins generator of capacity 1500 KW (Model: QST30-G4) which is located at General block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]EHS : Environment Health and Safety
[][]PPE : Personal Protective Equipment
[][]SOP : Standard Operating Procedure

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required
[][]Engage technician/mechanic/operator/supplier in repair and maintenance work

Operators

[][]To operate the generator according to the SOP.
[][]To fill up the logbooks related to the Generator.
[][]To do the maintenance according to the check list.

Head of Engineering

[][]To ensure that the operation and maintenance of generator are done properly.
[][]To approve any maintenance/plans related to the generator.

Head of Quality Assurance

[][]To approve this SOP
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. [][]Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Hearing protection must be used.

[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Do not smoke when put fuel in the tank.
[][]Do not make adjustment that doesn’t understand.
[][]Do not remove the filler cap or any component of the cooling system while the engine is hot and while the coolant is under pressure, because dangerous hot coolant can be discharged.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]“Under Maintenance” be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Engine Starting Procedure

Pre-Start Check

[][]Before the engine is started the operator should understand fully the reason for the controls and their use. The following check should be done before engine start.
[][]Check whether the Gas pressure is 10 psi or not.
[][]Make a general visual inspection on the engine and alternator. Check if there is any breakage, crack, leakage or looseness.
[][]Check the battery electrolyte level-fill with distilled water as necessary.
[][]Check that there is sufficient coolant level and if necessary, add the correct coolant.
[][]Check that there is sufficient lubricating oil in the sump & Viscosity and, if necessary add lubricating oil.
[][]Check the air filter and its connection.
[][]Check the all electrical connections are tight.
[][]Check the condition and tension of the fan end engine alternator belts-tighten as necessary.
[][]Check all hoses for loose connections or deterioration tighten or replace as necessary.
[][]Check the battery connection cables. Take care to tighten the loosened battery terminals with spanner and, cover with special substance and keep clean in order to avoid oxidation.
[][]Take out foreign materials such as keys, tools, cleaning wool, papers etc. on the engine and the Alternator.

Engine Start

[][]Reset the emergency stop.
[][]Press the reset button.
[][]Start key turn to the “ON” Position
[][]After start key turn to “ON” position following are checked:
[][]Check for any abnormal noise or vibration.
[][]Check for fluid leakage or leaks in the exhaust system.
[][]Check the control panel for indications of abnormal operations, particularly abnormally high temperature or low oil pressure. The oil pressure should be in the normal range within about 10 seconds of starting.
[][]Switch the alternator circuit breaker to “ON” (Handle Up).

Caution:

[][]Load can now be applied to the generating set (Normally 2-3 minutes wait from pressing the start button). The maximum step load can be 70%-100% of rated power depending on the generating set model. Typically we run 80% of rated load.
[][]Do not operate the engine at high speeds without a load.
[][]Do not overload the engine.

Engine Stopping Procedure

[][]Reduce the load gradually to the range of 0 – 50 kW.
[][]Turn off the load by switching output circuit breaker to “OFF” (Handle Down).
[][]Allow the generating set to run without load.
[][]After 2-3 minutes the key turn to the “OFF” position.
[][]In case of an emergency where immediate shutdown is necessary, the emergency stop push button should be pushed immediately without discounting the load.

Preventive Maintenance Planning

The preventive maintenance periods apply to average conditions of operation. The schedule which follows must be applied at the Interval (hours or months) which occur first.

Maintenance Interval with Maintenance action to be taken

Daily Maintenance

[][]Visually inspect engine, generator, transfer switch and Control panel.
[][]Clean the machine exterior and its surroundings.
[][]Ensure that the coolant is at the correct level.
[][]Check Oil, Water leaks.
[][]Check the amount of lubricating oil in the sump.
[][]Check the lubricating oil pressure at the panel display.
[][]Check the battery charge level.
[][]Check the air inlet filters.
[][]Drain air tank moisture and sediment.
[][]Inspect the engine fan blades.
[][]Inspect the drive belt.
[][]Check the intercooler and the coolant radiator for debris.
[][]Inspect and check the generator load and power factor.
[][]Check the voltage and frequency frequently

Weekly Maintenance

[][]Repeat Daily Check.
[][]Check Fuel lines and connections.
[][]Check for adequate fresh air to engine.
[][]Check hose and connections.
[][]Check battery charging alternator belts.
[][]Inspect the engine fan blades.
[][]Inspect the fan belt.
[][]Check oil level (Governor Housing).
[][]Check exhausts leakage.
[][]Tighten connections.
[][]Check Panel display.
[][]Tighten covers.
[][]Check output voltage and frequency.
[][]Inspect operation under load.
[][]Check for any unusual sounds.
[][]Terminals and connections normal color.
[][]Check if doors closed securely.

Monthly Maintenance

[][]Repeat weekly check.
[][]Clean the air filters.
[][]Check All fittings, Clamps, fasteners etc.
[][]Check generator air outlet.

After every 2500 Hours

[][]Tapped adjustment.
[][]Change lubricating oil.
[][]Change the lubricating oil filters.
[][]Change spin on filter.
[][]Change Air filter.

After every 16000 hours

[][]Change lubricating oil.
[][]Change the lubricating oil filters.
[][]Change spark plug cables.
[][]Clean/replace Gas filters and check/replace fuel hoses.
[][]Clean/replace air filter elements.
[][]Check for any leakage on engine, line and drains.
[][]Check crankcase venting valve and the crankcase pressure.
[][]Check/replace of all engine compensators.
[][]Check pumps and heat exchangers/radiator/cooling tower.
[][]Check engine starting battery, starting motor/starting system.
[][]Check/adjust valve clearances.
[][]Check engine safety controls, protection.

[][]Visually check turbocharger.
[][]Check push roads, cylinder head valve springs and valve heights.
[][]Check engine support, base rail level and anti-vibration pads
[][]Check air intake/exhaust system.
[][]Check engine governor.
[][]Check for any vibration or noise of engine
[][]Check cable termination.
[][]Check Genset control panel and instruments.
[][]Check performance and parameters of Genset during operation.

After every 32000 Hours

[][]Overhauling of engine
[][]Ensure that the turbocharger impeller and the turbocharger compressor casing are cleaned
[][]Ensure that the alternator, the starter and the turbocharger are checked
[][]Check the turbocharger bearing clearance.
[][]Check the exhaust restriction.
[][]Check the valves settings.
[][]Check, adjust and replace the ignition system spark plugs.
[][]Check vibration damper.
[][]Clean Turbocharger compressor wheel and diffuser.

After every 64000 Hours

Overhauling of full generator.
Ensure that the turbocharger impeller and the turbocharger compressor casing are cleaned.
Ensure that the alternator, the starter and the turbocharger are checked.

Annexure:

Annexure-I: Maintenance logbook of 1500 KW gas generator
Annexure-II: Log sheet for 1500 KW gas generator

Filter cleaning procedure, Purpose:

Filter cleaning procedure, The purpose of this SOP is to define the cleaning procedure of filters of various process machines of Production, Product Development and Warehouse departments.

Scope:

This Standard Operating Procedure applies to the fluid bed dryers, coating machines, dust collectors of tablet compression machine, laminar air flow unit, dispensing and sampling booths of production, product development and warehouse department which are located of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]FBD: Fluid Bed Dryer.
[][]HEPA: High Efficiency Particulate Air.
[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]W.C: Water column (pressure unit).
[][]PD: Product Development.
[][]PAO: Poly Alpha Olefin.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support to the technician for cleaning the filters.
[][]To check that the filters are properly cleaned/changed.
[][]To check that the log book is properly filled.

Technician

[][]To clean/change the filters when necessary.

Head of Engineering

[][]To ensure filters are cleaned/changed according to the SOP.

Head of Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use all Personal Protective Equipments such as goggles, masks, hand gloves etc. during cleaning/changing the filters.
[][]Disconnect the electrical power before opening the filters.
[][]Ensure all utilities before doing any kind of cleaning/changing task.

Cleaning and Changing procedure:

[][]Filters of FBD: There are five types of filters in FBD such as pre filter, medium filter, HEPA filter, product retaining filters and the cartridge filters of dust collector.
[][]To clean the cartridge filters and pre filters following procedures are followed:

Dismantle the filter from the filter housing.

[][]Clean the filters using compressed air at a pressure of 1-2 bar.
[][]Then take the filters to the filter cleaning area  and keep the filters drowning in the potable water for 2-3 hours.
[][]Then take out the filters from the water and partial drying is done by blowing compressed air at a pressure of 1-2 bar.
[][]After that, dry the filters under the sunlight.
[][]Finally, compressed air is used after sunlight to remove any dirt from the filters.
[][]Fix the filter into the filter housing.
[][]The pre filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]The cartridge filters are cleaned if the differential pressure is equal to or more than 4 in. of W.C. An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The medium filters and HEPA filters of inlet air handling unit are checked on every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]The product retaining filters are cleaned through production SOP.
[][]Filters of Coating machine: There are four types of filters in the coating machine such as: pre filter, medium filter, HEPA filter and cartridge filters of dust collector
[][]The cleaning procedure of pre filter and cartridge filter of dust collector is as same as it is described in the previous section The filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]An exchange of the filters is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filters is worn out.
[][]The medium filter and HEPA filters of inlet air handling unit are checked every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]Filters of Dust Collector of Tablet Compression machine: They are cleaned using compressed air at a pressure of 1-2 bar after each batch of operation. Full cleaning (as per the procedure described in the previous section is done after 5 batches of operation.

Filters of Dispensing and Sampling Booth:

[][]There are pre filter, medium and HEPA filters in dispensing and sampling booths.
[][]The pre filters are cleaned on every month according to the procedure described in the previous section.
[][] The medium filters are cleaned using compressed air at a pressure of 1-2 bar when the differential pressure across the filter is equal to or more than 250 Pa.
[][]An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The HEPA filters are changed when the differential pressure across the filter is equal to or more than 400 Pa.

Filters of Laminar Air Flow unit of Dialysis Fluid area:

[][]There are two types of filters in the Laminar Air Flow unit such as: Pre filter and HEPA filter.
[][] The cleaning procedure of pre filter is as same as it is described in the previous section .
[][]The pre filter will be cleaned after every 15days.
[][]The HEPA filter will be checked on every month and will be changed if the differential pressure exceeds 250 Pa.
[][]An exchange is only required, if dirt is visible or any part of the filters is worn out.
[][]The filter integrity test (PAO test) of all the HEPA filters will be performed on every year.
[][]The filters will be changed in case of failure to meet the acceptance criteria of this test.
The technician will fill up the log books of filter cleaning/changing after cleaning or changing the filters.

Annexure:

Annexure – I: Log book of cleaning the filters of process machines
Annexure – II: Log book of changing the filters of process machines

Color Coding, Purpose:

Color Coding, The purpose of this SOP is to define the color coding procedures of utility lines  of XX Pharmaceuticals Ltd.

Color Coding, Scope:

This SOP covers the color coding procedure of utility lines in Production, PD, QC and Microbiology area of of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water
[][]CA: Compressed Air
[][]WFI: Water For Injection
[][]Elec: Electric line
[][]PoW: Potable water
[][]HW: Hot potable water
[][]NT: Nitrogen line
[][]PD: Product Development
[][]CWFI: Cold Water For Injection

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.
[][]Identification of the utility lines with the assistance of Engineering persons.

Engineering (Maintenance)

[][]To put on the labels on respective utility lines.

Respective department

[][]To ensure that the labels are properly maintained.
[][]To inform the engineering department if any label is torn or harmed by any means.

Head of Engineering

[][]To ensure that all the utility lines are properly labeled.

Head of Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Annexure:

N/A

Procedure:

Cleaning and Changing procedure:

[][]The list of utility lines which are to be marked is as follows:
[][]Purified water Potable water
[][]Cold Water For Injection
[][]Hot potable water
[][]Water for injection
[][]Compressed air Pure steam
[][]Nitrogen line
[][]Electric cable

The color coding procedure of each line is described below:

Purified water:

[][]All Purified Water lines must be tagged using an arrow head, Dark green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURIFIED WATER” must be written in the middle of the tag and the font would be Cambria, bold, and black color on white background as well. The sample of the tag is shown below:

Potable Water:

[][]All Potable Water lines must be tagged using an arrow head, light green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Hot Potable Water:

[][]All Hot Potable Water lines must be tagged using an arrow head, light green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “HOT POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold black color on white background as well.

Water For Injection:

[][]All WFI lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Compressed air:

[][]All Compressed Air lines must be tagged using an arrow head, dark blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “COMPRESSED AIR” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Pure Steam:

[][]All Pure Steam lines must be tagged using an arrow head, ash colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Nitrogen:

[][]All Nitrogen lines must be tagged using an arrow head, light blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “NITROGEN” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Electric line:

[][]All electric lines must be tagged using an arrow head, red colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “ELECTRIC CABLE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Cold Water For Injection:

[][]All Cold Water For Injection lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a light blue color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Chilled Water:

[][]All Chilled water lines must be tagged using an arrow head, blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “CHILLED WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Pure Steam condensate:

[][]All Pure Steam condensate lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a yellow color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM CONDENSATE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

[][]All the tags will be put on the utility lines by the respective engineer.
[][]The tag will be maintained properly by the respective departmental persons. If the tag is torn or harmed by any means, the engineering department must be informed to replace it.

AC Store Room, Purpose:

AC Store Room, The purpose of this SOP is to define the standard operating and maintenance procedure of AC store room in order to ensure its smooth & trouble-free operation.

AC Store Room, Scope:

This Standard Operating Procedure applies to the AC store rooms  of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]AC: Air Conditioner.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of AC  room.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the AC room according to the SOP.
[][]To do the maintenance according to the check list and fill up the maintenance log book.

Manager, Engineering

[][]To ensure that the operation and maintenance of air compressor are done properly.
[][]To approve any maintenance/plans related to the compressor.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use personal protective equipment before doing any kind of maintenance.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one doing any kind of maintenance of machine.
[][]Switch off the power before doing maintenance.

[][]Keep the door shut while the AC is running.

System Description:

[][]There are two split type AC in the AC store room to maintain the desired temperature. The capacity of each AC is 2.5 ton. Each cooling unit consists of one indoor unit and one out door unit. The operation of AC is remote controlled. The desired temperature is set using the remote.
[][]Two ACs do not run at a time. While one runs another one stands by.

Operating Procedure:

[][]Starting of AC of AC store room:
[][]Insert the plug of AC into the power socket and switch ON the power.
[][]Press the button on the remote to switch ON the AC.
[][]Set the desired temperature by pressing up and down arrow key.
[][]Select the AUTO or COOL mode by pressing the button.

During Operation:

[][]During operation the temperature of AC store room is controlled automatically in automatic mode.
[][]The AC of AC store room is kept running 24 hrs. When one AC runs another one stands by.

Stopping procedure:

[][]Press button to switch OFF the AC.
[][]Unplug the plug from the power socket.

Maintenance Program:

Monthly Maintenance

[][]Check the current consumption of Compressor.
[][]Clean the filter.
[][]Clean the evaporator coil by blower.
[][]Clean the outdoor unit.
[][]Check and clean the blower.
[][]Check the refrigerant pressure. The pressure should be 50 – 60 psi. If the gas pressure is lower, recharge with new refrigerant.
[][]Check for any icing over the evaporator coil.

Half yearly Maintenance

[][]Overhauling of the whole machine.

Annexure:

Annexure I Equipment Use Log Book
Annexure – II: Maintenance of AC store room

Cold Room, Purpose:

Cold Room, The purpose of this SOP is to define the standard operation and maintenance procedure of Cold room in order to ensure its smooth & trouble-free operation.

Cold Room, Scope:

This Standard Operating Procedure applies to the Cold rooms which are located at General and Cephalosporin Block.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of cold room.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the cold room according to the SOP.
[][]To do the maintenance according to the check list and fill up the maintenance log book.

Head of Engineering

[][]To ensure that the operation and maintenance of air compressor are done properly.
[][]To approve any maintenance/plans related to the compressor.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

 Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use personal protective equipment before doing any kind of maintenance.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one checking or working on the control panel of the machine.
[][]Keep the door shut during operation.

System Description:

[][]The Cold room of both Cephalosporin and General Block has been manufactured by Frigair.
[][]The raw materials are stored in the room at a temperature of 2 – 8 ⁰C. There is a split type AC of capacity 5 ton to maintain the temperature.
[][]The indoor unit contains evaporator, blower etc.
[][] The outdoor unit contains compressor, condenser, oil separator, filter dryer etc. There is a data logger to monitor the temperature of cold room for 24 hrs.

Operating Procedure:

Starting of Cold room:

[][]Switch ON the main switch. The Yellow and blue indicator will be ON.
[][]Then switch ON the blower by turning the switch to ON position. The blue indicator light will be ON.
[][]After 5 minutes compressor will be ON automatically. The BLUE indicating light will be ON.
[][]To set the required lower temperature, press the SET button. Then press up and down arrow button to set the required temperature.
[][] The temperature band is programmed as 5.5⁰C i.e if the lower temperature is set at 2.5 ⁰C, the higher temperature will be automatically set at 8.0⁰C.

During Operation:

[][]During operation check for any alarm. If the compressor and blower trip then the trip light will be ON and buzzer will give alarm.
[][]If the temperature of cold room becomes very much lower, the CC Heater will be ON and compressor will be OFF.
[][]In that case, the CC heater indicating light will be ON.
[][]In case of icing, the compressor, blower will be OFF and CC heater will be ON. The Defrost indicating light will be ON.
[][]Check the temperature in the display of monitor.
[][]Check the data logger. Change the page once a week because one page is used for a week.

Stopping procedure:

[][]Switch off the compressor by turning the switch to OFF position. The indicating light will be OFF.
[][]Then switch off the blower by turning the switch to OFF position. The indicating light will be OFF.
[][]Switch off the main switch. The Yellow and Blue indicating light will be OFF.

Maintenance Interval/ Maintenance action to be taken

Daily Maintenance

>>Check for any alarm.
>>Check whether all the equipments operate sequentially.

Weekly Maintenance

>>Clean the outdoor unit.
>>Clean the blower.
>>Clean the drain pan of indoor unit.

Monthly Maintenance

>>Check the refrigerant pressure.
>>The pressure should be 50 – 60 psi.
>>If the gas pressure is lower, recharge with new refrigerant.

Annexure:

Annexure I Equipment Use Log Book
Annexure – II: Maintenance log book of Cold room