High Speed Mixer Granulator, Purpose:
High Speed Mixer Granulator, The purpose of this SOP is to define the operation and cleaning procedure of high speed mixer granulator.
High Speed Mixer Granulator, Scope:
This SOP is applicable for operation and cleaning procedure of High Speed Mixer Granulator in product development of XX Pharmaceuticals Ltd.
Definition / Abbreviation:
None
Responsibilities:
The roles and responsibility are as follows:
Operator / Supervisor Product Development
[][]Operation and cleaning of the High speed mixer granulator
[][]Maintaining operation and cleaning log book
Executive / Sr. Executive Product Development
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
Manager, Quality Assurance, Manager
[][]Ensure that the SOP reflects actual operation and cleaning procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
[][]Machine Assembling
[][]Before operation assemble the machine change parts that are necessary for certain type of operation.
[][]Install the filter bag at the machine lid cover port for air discharge and install the filter bag housing. Attach the shaking ring with the filter bag.
[][]Ensure that the discharge port is closed.
[][]Install the feed hopper at the lid cover of the machine. Check for the proper working of the valve.
Machine Operation
[][]Install the compressed air line in the machine, open the compressed air valve and observe that the air pressure is not more than 4 Bar.
[][]Turn the machine ON/OFF switch (main switch at the right down corner of the machine) to ON. Control panel light will illuminate and the machine is ON
[][]Lift the lid cover manually to upward and fill with sufficient quantity of raw material (3-6 kgs)
[][]Down the lid cover manually and lock with the manual locking devices by pressing the locks downward. Check for the proper locking of the lead cover.
[][]Turn the pilot lamp switch right to ON the lamp and left to OFF the lamp
[][]Set the mixing time (as desired) at the electric timer unit manually. Timer display shows the time in XX min and XX Sec mode. Press the upper button (▲) of timer unit to increase the time and down button (▼) to decrease.
[][]Set the agitator and chopper RPM to desired value through the speed adjust nobs in the control panel. Rotate clockwise to increase the RPM and anticlockwise to decrease the RPM.
[][]Press the agitator ON button (green) to start the agitator and chopper ON button (green) to start the chopper. Look for the actual speed of the agitator and chopper at the display. [][]Adjust where adjustment is necessary.
[][]To OFF the agitator or chopper, push the agitator or chopper OFF button (red).
[][]To add binder solution or water, OFF the agitator and chopper. Pour the solution in to the feed hopper. ON the agitator or chopper as required and pull the feed hopper valve upward. [][]Push back the valve after the whole solution is added.
[][]To run the process more than its predetermined time. Reset the time after completion of the process. ON agitator and chopper again.
[][]To stop the machine immediately, Push the emergency button backward, machine will be stopped immediately. To release from emergency stop, rotate the emergency button clockwise and pull inward, light will illuminate and the machine is started.
[][]To check the granules during process. OFF the agitator and chopper. Shake the filter bag through filter bag housing. Wait at least for 1 minute to allow the powders to settle down and lift the machine lid cover manually.
[][]To discharge the granules after process completion of process. Rotate the discharge valve (at the back of the machine) clockwise, discharge chute will open automatically. To close the discharge chute rotate the valve anticlockwise.
[][]Place a poly bag or bowl at the discharge port to hold the discharging granules.
[][]Granules can be discharged both automatically and manually. Choice of the discharging process will depend on the granules condition.
[][]To discharge the granules automatically push the agitator ON button (green) by keeping the discharge valve open. When granules are discharged Push the OFF button (red). Open the lid cover and manually scavenge the remaining granules through the discharge port.
[][]To discharge the granules manually open the lid cover of the machine and manually pass the granules through the opening of discharge unit. Scavenge all granules manually.
[][]Turn the pilot limp button left to Off the pilot lamp.
Machine Dismantling
[][]Turn the machine ON/OFF button to OFF. The machine light will be OFF
[][]Remove the filter bag housing and the filter bag of the machine
[][]Remove the feed hopper from the machine
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Cleaning of filter bag housing and feed hopper
[][]Clean the filter bag housing with clean markin cloth to remove solid and semisolid dusts
[][]Clean with potable water by rubbing with a cloth.
[][]Clean with damp cloth to remove any dust adhering to the parts.
[][]Clean with hot water and then with purified water.
[][]Soak with a clean dried markin cloth to remove the water from the parts
[][]Allow removal of all water and dry with compressed air.
[][]Wrap with poly bag, attach “CLEANED” label and store in the accessories cabinet.
Cleaning of filter bag
[][]Clean the filter bag with potable water.
[][]Soak the filter bag in detergent water and retain for 30 minutes
[][]Wash the filter bag 3 times by rubbing with potable water
[][]Wash the filter bag with hot water and finally with purified water.
[][]Squeeze the filter bag to remove water and allow to dry in the wash bay
[][]After drying take the filter bag in a poly bag, attach “CLEANED” label and store in the accessories cabinet.
Cleaning of the main machine
[][]Place the drainage tank under the discharge valve and make sure that the discharge port is closed.
[][]Make sure that air purging is between 1-2 bar.
[][]Open the lid and fill purified water until the chopper is flooded with water. Make sure that water bubbles come out from each shaft seals indicating that compressed air is supplied through the seals to protect water from penetrating into the driving unit.
[][]Close the lid and activate both agitator and chopper. Ensure that both agitator and chopper operate as normal.
[][]Be sure no purified water comes out through the lid seal.
[][]After a while, check inside the machine whether the product left in the bowl is dissolved into the purified water.
[][]Continue the agitator and chopper operation as necessary.
[][]Open the discharge valve to remove filthy water from the bowl into the tank
[][]Clean the inner parts, agitator and chopper of the machine with a damp cloth to remove any insoluble particle
[][]Rewash the machine with potable water in same procedure
[][]Rewash the machine with hot water and then with purified water following same procedure
[][]Clean the discharge valve, bowl and external surface with damp cloths.
[][]Wipe the water droplets with clean and dry cloth, and allow the machine to dry with compressed air.
Annexure:
Annexure – I: Operation and cleaning log book.