Injection -Line clearance SOP
Objective:
To lay down the procedure for line clearance of manufacturing and warehouse areas.
Scope:
This SOP is applicable for line clearance of production (Injection), and warehouse activities held at the Formulation plant.
Responsibility:
The operator/Supervisor shall be responsible for proper cleaning of equipment / area.
Warehouse/ Production Chemist/ Officer shall be responsible for checking the cleanliness of the area / equipment.
IPQA Officer shall be responsible for giving Line Clearance.
Accountability:
Head-Q.A
General Procedure for line clearance (To be followed for every area)
The production person shall check for cleanliness & intimate the IPQA for Line Clearance.
IPQA person shall visually ensure the cleaning of the entire area and equipment after every product/batch changeover
IPQA person shall ensure that there are no traces of labels, powder/material of the previous product.
IPQA person shall ensure that the room temperature and relative humidity are as per specified limits.
IPQA person shall ensure that the room differential pressure is as per the specified limit.
IPQA person shall ensure that AHU return riser filters are cleaned after every product changeover.
The IPQA person shall ensure that all the documents related to environmental monitoring, area cleaning, equipment logbooks, area particle count records, etc. are completed till date.
IPQA shall ensure that all the measuring devices installed in the equipment are calibrated and calibration tags are available.
After verification of all required checkpoints, IPQA personnel shall give the line clearance. Record the line clearance observation in the batch manufacturing record
Line clearance for Dispensing
Check and ensure that the area /equipment is visually clean & the “CLEANED” label is attached to the equipment.
Ensure the temperature and relative humidity are within the specified limit.
Ensure that RLAF is working properly
Ensure that the weighing balances are calibrated.
Ensure that the riser filters are cleaned after every product changeover.
Check the raw material/packing material for name, material codes, appearance, A.R. No., Expiry/retest date, etc.
Line clearance for Bung Processor cum Steam-Sterilizer
Ensure that the bung processor room is free from water spillage and remnants of previous products / Batches.
Ensure that the critical area side door is closed as indicated by the indicator lamp on the control panel.
Check that the chamber and area are visibly clean and no remnants of the previous batch /product are present in the sterilization chamber and trolley.
Dynamic Pass box of the room is working properly for the movement of material.
Line clearance of vial washing machine.
Ensure that the vial washing area is visibly clean and free from water spillage and no vials of the previous batch/product are present.
Check below the machine, inside the machine, and outfeed of the machine for the presence of any broken glass pieces/leftover glass vials.
Check that the re-circulated water tank, WFI tank & Purified water tank are empty and visually clean.
Check the pressure of re-circulated water, WFI, and purified water as mentioned in BMR
Line clearance for Dry heat sterilization tunnel
Check that the sterilizing tunnel and the area are visibly clean and no vials of the previous batch /product are present on the conveyor.
Check below and inside of the sterilizing tunnel for the presence of any leftover glass vials / broken glass piece.
Check the cleanliness of the conveyor by wiping the surface of the conveyor with a white lint free wipe. Check the wipe for the presence of any coloration.
Ensure that the damper of the sterilizing zone is adjusted as per the size of the vials.
Line clearance of Vial filling and bunging machine
Ensure that the room temperature, relative humidity, and room differential pressure are as per specified limits.
Ensure that all the personnel working in the area shall wear secondary gowns, goggles, hand gloves etc. specified for filling area.
Dynamic Pass box of the room is working properly for the movement of material.
Ensure that weighing balances are calibrated.
Ensure that the vial filling room and filling machine parts are visibly clean and no remnants of the previous batch /product are present.
Check on/below the in feed and out feed turntable for the presence of any broken/left over vials of the previous batch /product.
Check that the raw material of the previous product is not present in the room.
Check the status tag on the nitrogen, compressed air & vacuum line filters.
Ensure that the rinse water sample report of vial filing machine is cleared by the Quality Control department for residual contact of previous processed product in case of product change over.
Ensure that all the cleaning procedures have been followed prior to line clearance and recorded. Non-viable particle counts (in static condition) of filling and cooling area shall also be checked.
Ensure that AHU return riser filters are cleaned after every product changeover.
If the breakdown is more than 5 minutes, then line clearance should be taken again.
Line clearance for sealing machine
Ensure that the sealing machine and sealing area are visibly clean and that no seals, vials, or stoppers of the previous batch /product are present.
Dynamic Pass box of the room is working properly for the movement of material.
Ensure that no rejection of the previous batch/ product is present in the room.
Check the hopper chute conveyor on/below the machine and inside the panel for the presence of any broken/leftover vials, stoppers, and seals of the previous batch/product.
Line clearance for visual inspection, labeling & Packing
Ensure that all the filled and sealed vials of the previous batch /product have been removed from the visual inspection machine.
Ensure that no broken/leftover remnants of the previous batch/product are present on/below the visual inspection machine.
Ensure that the personnel involved in visual inspection wear hand gloves.
Ensure that the lights of the visual inspection machine are working.
Ensure that the labeling machine is visually cleaned and no labels of the previous batch /product are present.
Ensure that the weighing balances are calibrated.
Ensure that no label/cartons/insert/intermediate boxes corrugated boxes of the previous batch /product are present on/ below the packing line.
Check that the conveyor belt is clean.
Change the status tag on the machine for the new batch/product.
Record the line clearance observation in the batch production record.
Checklist For Line Clearance for DISPENSING
Check and ensure that the area /equipment is visually clean & A “CLEANED” label is attached to the equipment
Ensure the area is free from previous products and unwanted materials
Ensure the temperature and relative humidity are within the specified limit
Ensure the differential pressure of the area is within the specified limit
Check the proper gowning of personnel
Check the present status of a label which shows the details of the activity
Ensure that RLAF is working properly
Ensure that the weighing balances are calibrated
Check the raw material/packing material for name, material codes, appearance, A.R. No., Expiry/retest date, etc.
Ensure that the riser filters are cleaned after every product changeover.
LINE CLEARANCE CHECKLIST FOR BUNG PROCESSOR
Check and ensure that the area /equipment is visually clean & the “CLEANED” label is attached to the equipment.
Ensure the area is free from previous products and unwanted materials.
Ensure the temperature and relative humidity are within the specified limit
Ensure the differential pressure of the area is within the specified limit.
Check the proper gowning of personnel.
Check the present status label which shows the details of the activity.
Ensure that the riser filters are cleaned after every product changeover.
LINE CLEARANCE CHECKLIST FOR VIAL WASHING AND STERILIZING TUNNEL
Check and ensure that the area /equipment is visually clean & the “CLEANED” label is attached to the equipment.
Ensure the area is free from previous products and unwanted materials.
Ensure the temperature and relative humidity are within the specified limit.
Ensure the differential pressure of the area is within the specified limit.
Check the proper gowning of personnel.
Check the present status label which shows the details of the activity.
Ensure riser filters are cleaned after every product changeover.
Ensure the availability of BMR and fill up to the previous stage.
LINE CLEARANCE CHECKLIST FOR VIAL FILLING AND BUNGING
Check and ensure that the area/equipment is visually clean & the “CLEANED” label is attached to the equipment.
Ensure the area is free from previous products and unwanted materials.
Ensure the temperature and relative humidity are within the specified limit
Ensure the differential pressure of the area is within the specified limit.
Check the proper gowning of personnel.
Ensure the swab analysis of the equipment to be used has passed.
Check the present status label which shows the details of the activity.
Ensure riser filters are cleaned after every product changeover.
Ensure the availability of BMR and fill up to the previous stage.
Ensure that the area cleaning has been done as per the defined procedure and that non-viable particle counts (in static conditions) are within the limit.
Ensure the dynamic pass box attached to the area is working for material movement.
LINE CLEARANCE CHECKLIST FOR VIAL SEALING
Check and ensure that the area /equipment is visually clean & the “CLEANED” label is attached to the equipment.
Check the area is free from previous products and unwanted materials.
Ensure the temperature and relative humidity are within the specified limit
Ensure the differential pressure of the area is within the specified limit.
Check the proper gowning of personnel.
Check the present status label which shows the details of the activity.
Ensure that the equipment Logbook is filled up to the previous stage.
LINE CLEARANCE CHECKLIST FOR VISUAL INSPECTION, LABELING, AND PACKING
Check and ensure that the area/equipment is visually clean & the “CLEANED” label is attached to the equipment.
Check the area is free from previous products and unwanted materials.
Ensure the temperature is within the specified limit
Check the present status label which shows the details of ongoing activity.
Verify the issued secondary and tertiary packaging material concerning BPR.
Check the carton, outer, label, and shipper coding for its Batch No., Mfg. date, Exp. date, M.R.P. etc.
Ensure the conveyor belt is free from any previous product and unwanted material.
Ensure that the coded secondary packing materials are kept in cleaned plastic carats with a status label attached.
Ensure the REJECTED LABELED container is available for rejected strip/blister
Ensure that the weighing balances are calibrated.
Check and ensure the carton weighing range slip is placed near the weighing balance.