Fluid Bed Processor, Purpose :
Fluid Bed Processor, The purpose of this SOP is to describe the operation and cleaning procedure of Fluid Bed Processor (Model: FBD 5) in order to comply with cGMP standard.
Fluid Bed Processor, Scope :
The scope of the procedure is applicable to the Fluid Bed Processor (Model: FBD 5) at the Product Development area of General block of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
None
Responsibilities:
The roles and responsibility is as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the Fluid Bed Processor (Model: FBD 5).
[][]Maintaining operation and cleaning log book
Officer/ Sr. Officer, 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 Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation, cleaning and maintenance procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. Master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
[][]Machine Assembling
[][]Installation of finger type filter bag.
[][] Attach the filter bag with the filter bag lower clamp and tighten with a screw.
[][]Install compressed air line through pneumatic service unit, turn on the compressed air line and make sure that compressed air is regulated to 6 bar
[][]Release the emergency switch and turn on the main control, to supply electricity to the control panel
[][]Press filter Move down to lower the filter bag holder, clamp the clean filter bag to all hooks of the filter bag holder
[][]Press filter move Up to move to raise the filter bag holder up until in reaches the locking position
[][]Filter ba seal lamp illuminates in green to indicate that the filter bag is in locking position. If the filter bag is not locking in position the filter bag seal lamp illuminates red to indicate that the filter bag is not lock in properly.
[][]Test filter shaking to ensure that filter cleaning mechanism is functional.
Inlet air handling
[][]Inspect that pre-filter unit (EU4) of inlet air handling system is clean and does not clog.
[][]Check that there is no air leakage in the air handling and duct.
[][]Ensure that differential pressure across the medium filter is less than 2.0
[][]Check that differential pressure across the Hepa filter is less than 2.0
Exhaust air handling
[][]Check that there is no air leakage in the inlet air handling and duct
[][]Ensure that differential pressure across the dust collector is less than 2.0
[][]Ensure that differential pressure across the medium filter is less than 2.0
[][]Make sure that before starting the machine the drain valve and other ports are closed.
[][]Pneumatic service unit.
[][]Check lubrication level of air lubricator
[][]Drain water from air filter before the water level exceeds the upper limit.
[][]Inspect that there is no damage with pneumatic service unit and compressed air supply tubes
[][]Regulate main compressed air to approximately 6 bars.
[][]Check critical instrument calibration tags are still valid. If the calibration is expired, send the instruments for re-calibration.
Machine Operation
[][]Release the EMERGENCY SWITCH by pushing and turning it along the arrow head direction. Electricity will be connected to the electric control unit.
[][]Ensure that the main compressed air is regulated to 6 bar.
[][]Twist MAIN CONTROL OFF/ON selector. Then touchscreen would display, the cover page.
[][]Touch anywhere in the screen. This action leads user to Menu screen
[][]Load wet granules or other materials which need to dry into the fluid bed container
[][]Move the fluid bed container to align with the expansion air filter housing. The proximity sensor would locate the trolley position to ensure that it is in the correct position before lifting.
[][]Press CONTAINER button on the menu page. The system would lead user to container lift mode.
[][]At preliminary stage, system status are as follow
[][]Filter bag seal: OUT
[][]Container position: OUT
[][]Press ring seal: OUT
[][]Press CONTAINER UP button to raise the Fluid Bed container up until it is securely attached with the expansion/exhaust air filter housing.
[][]After the fluid bed container lifted to final position, system status would change to
[][]Filter bag seal: OK
[][]Container position: OK
[][]Press ring seal: OK
[][]Press exit to return to main page.
[][]Press DRY button at the Menu page. Dry Process Setting screen should appear on the screen.
[][]Set the following parameter by touching on the screen and push the pop-up numeric keys
[][]Heat Air Temp : Inlet heating air temperature in °C
[][]Overheat Temp : Overheat limit of inlet air in °C
[][]Heat Delay Time : Turn on the exhaust blower without heating for a while
[][]Drying Time : Desired drying time in min (minute). The system count the time only when the heating temperature is reached.
[][]Cooling Time : Time in min (minute) which the exhaust blower remains activated while the heating element is switched OFF.
[][]Filter Shake Interval : The time interval between each filter shaking in min (minute).
[][]Filter Shake Frequency : How many pulses of filter shaking required per interval
[][]After all dry parameters are set, press DRY PROCESS button to get into Dry Process screen.
[][]Press IAV to set the inlet air flap valve opening in % (percentage).
[][]The IAV setting range is 0 – 100 %.
[][]0 % : Fully close
[][]100 % : Fully open.
[][]Push DRY to turn on the exhaust blower and the heating system according to the Dry Parameter
Setting.
[][]For Spry Granulation, peristaltic pump as well as magnetic stirrer should be hook on to the system.
[][]Air Spray Pressure for spray can be set on Air Spray Pressure Regulator. Air Spray Pressure should be set around 0.5 – 1.0 bar (kg/cm2).
[][]SPRAY Pump Speed can set from 0 – 99 rpm at the peristaltic pump.
[][]For SPRAY AUTO, SPRAY direction [FIG.7] will be rotate CW. However, after stop SPRAY AUTO the peristaltic pump will rotate CCW for 5 sec to prevent any spray solution drop.
[][]For SPRAY MANUAL, press SPRAY MANUAL button on Dry Process page, then SPRAY PUMP MANUAL control will pop up. In this page, operator can manually control spray direction CW and CCW by pressing CW/CCW to Start/Stop pump direction. In addition, spray pump can be activate/ deactivate in this page by pressing SPRAY button. To exit SPRAY PUMP MANUAL press X button.
[][]Push SPRAY to turn start peristaltic pump to spray coating material to the granule. When the filter is
shake the Spray will automatically stop.
[][]LIGHT OFF/ON selector [No.10] can be twisted to ON so the spotlight is activated
[][]Drying Time in min (minute). Drying time show both Set Time (Green) and Actual time (Red). Drying time can be also set within this page. System only take into account the time when the actual inlet heating air temperature reaches the setting temperature.
[][]Cooling Time in min (minute). Cooling time show both Set Time (Green) and Actual time (Red). Cooling time can be also set within this page. System automatically turns off heater in the cooling phase.
[][]Heating coil becomes Red color while it is operating. It turns Yellow after inactivated.
[][]Lamp on Filter section turn ON while it is shaking.
[][]When the blower operates, Red lamp on the blower lights up.
[][]If Different pressure indicator that Finger-type filter is clog but it does not reach the shaking interval yet, press SHAKE to activate the filter shaking. To discontinue the filter shaking, repress SHAKE button one more time.
[][]Product sample can be collected through the provided sampling port to check product conditions.
[][]The drying proceeds until the setting time is reached, then the entire system would be automatically shut down.
[][]Press RESET to reset the timer values to zero.
[][]After the process is completed the filter will be shake as per set time and frequency or press SHAKE to clean the Finger type filter for a while
[][]Exit Dry Process and return to Menu page
[][]Press CONTAINER button Container Lift Screen appears on the touchscreen. Select CONTAINER DOWN. Then, seal and pneumatic cylinder system are released. Subsequently, the pneumatic cylinder system would lower the Fluid Bed container down.
[][]Remove Product Temperature Probe from the machine first.
[][]Remove the Fluid Bed container and dried product from the machine
[][]Press GRAPH button. GRAPH Screen appears on the touchscreen. GRAPH Screen record the following value.
[][]Overheat Alarm (ALARM)
[][]Inlet Air Temperature Set Point (SP: IAT)
[][]Inlet Air Temperature Present Value (PV: IAT)
[][]Product Temperature (PD: PDT)
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 exhaust air filter bag
[][]Press FILTER MOVE DOWN on Container Lift screen to lower the filter down. The exhaust filter bag holder will be released from the machine.
[][]Remove the filter bag from the holder.
[][]Use vacuum to remove the remaining product from the filter bag.
[][]Take the filter bag to cleaning area. Clean with potable water, use detergent if necessary
[][]Completely rinse the filter bag to remove any detergent present
[][]Clean with hot water and finally rinse with purified water.
[][]Dry the filter bag and take in a poly bag attach a cleaned label and store in machine change parts cabinet.
Cleaning of Product Container.
[][]Vacuum the remaining product from the product container.
[][]Use clean water to wash the product container and release the filthy water through the sampling valve. Use hot water as necessary
[][]Remove the bottom screen for extensive clean as necessary.
[][]Thoroughly clean the sampling valve and sight glass.
[][]Repeat the cleaning until the product container is completely cleaned.
[][]Rinse with purified water.
[][]Use damped cloth the clean the external surface of the product container
[][]Remove the water droplet with dry and clean cloth, starting with product contact surface first and follow by non-product contact.
[][]Apply heated air from the inlet air supplied through the electrical heater.
[][]Cleaning of expansion/exhaust air filter housing
[][]Vacuum the remaining product from the internal surface.
[][]Use damped cloth the clean the internal surface. Pay special attention to the seal area.
[][]Repeat the cleaning until the unit is totally clean.
[][]Use damped cloth to clean the external surface of the product container.
[][]Remove the water droplet with dry and clean cloth, starting with product contact surface first and follow by non-product contact.
[][]Apply heated air to completely dry both internal and external surface. It is also applicable to apply heated air from the inlet air supplied through the electrical heater.
[][]Inspect inside the Fluid Bed container and the Expansion/Exhaust filter housing chamber for cleanliness.
[][]Enter Dry Mode and use the heated air generated by the inlet air handling to dry the internal surface of the Fluid Bed Processor.
[][]Use damped cloth the clean the external surface of the machine as necessary.
[][]Wipe with dry cloth to remove remaining water from the external surface. Start wiping the critical area first.
[][]Dry the machine with heated air to expedite the drying rate. Otherwise, leaving the machine to dry up in the clean operating room.
[][]Once the cleaning is completed, attach a cleaned label in the machine
Annexure: Fluid Bed Processor
Annexure – I: Operation and cleaning log book.