Objective:
To lay down a procedure for cleaning during media fill trial and decontamination after completion of media fill trials.
Scope:
This SOP describes the procedure for cleaning during media fill trials and decontamination after completion of media fills trials.
Responsibility:
Production Officers / Executive.
Accountability:
Production Head shall be accountable for the compliance of SOP.
Abbreviations
SOP : Standard Operating Procedure.
S.S. : Stainless Steel
LAF : Laminar Air Flow
Procedure:
Daily cleaning in vial filling room during media fill trial campaign
After completion of media fill trial transfer stoppered carboys containing left over media to cool zone through pass box and then to controlled area through steam sterilizer. From controlled area send the carboys to microbiology department for incubation of left over media for further studies.
Dismantle the liquid filling machine parts and transfer them to cool zone through pass box and then to controlled area through steam sterilizer for their cleaning as per SOP and next sterilization.
Transfer the remaining vials, stoppers, to cool zone through pass box and then to controlled area through pass box.
Critically inspect the vial filling & bunging machine and area for any spillage of media. Clean the same with the disinfectant solution.
Thoroughly clean, sanitize and disinfect the in-feed turn table, out-feed turntable and conveyor belt.
Clean, sanitize and disinfect the balance, SS balance table, micro plate exposing stands, view panels, doors. Ceiling, walls and floor of vial filling room as per SOP.
Clean and disinfect the non-detachable parts of vial filling and bunging machine with WFI and disinfectant solution.
Daily cleaning in cool zone
Clean and sanitize the pass box and as per SOP.
Clean and sanitize the view panels, ceiling, doors, walls and floor of cool zone & sampling room as per SOP.
Clean and sanitize the particle counter, SS table, SS rack.
Clean and sanitize steam sterilizer, stand trolley as per SOP.
Transfer all the left over material such as SS tools to the controlled area for cleaning and sterilization through pass box.
Clean and sanitize the LAF, SS pallet, and Pass BOX with WFI soaked mope followed by disinfectant soaked mope.
Daily cleaning in sampling room, sterile passage and air locks
Transfer all the left over material such as spatula, empty sampling bottles and other accessory used in sampling to the controlled area through pass box.
Clean sanitize and disinfect the sampling room, sterile passage and aseptic area entry air lock I, II, III, entry buffer, exit buffer, exit air lock I, II and sump as per SOP.
Decontamination of aseptic area at the end of media fill campaign
First perform the Cleaning in vial filling room during media fill trial campaign, daily cleaning in cool zone & sampling room and daily cleaning in sterile passage and air locks.
Dismantle the liquid filling machine parts and transfer them to cool zone through pass box and then to controlled area through steam sterilizer for their cleaning as per SOP and next sterilization
Critically inspect the vial filling machine and room for any spillage of media droplets and clean the same with disinfectant solution.
Clean the return air riser filters as per SOP.
Clean the pre filters of laminar air flow unit as per SOP.
Dismantle the vial filling & bunging machine as per SOP.
Critically inspect the vial filling & bunging machine parts for any spillage of media. Clean the same with the disinfectant solution.
Transfer all the machine parts to cool zone through pass box and then to controlled area through steam sterilizer for further cleaning and sterilization.
Dismantle the Compressed Air / Nitrogen line filters and clean them as per SOP.
Transfer Compressed Air / Nitrogen line filters to cool zone through pass box and then to controlled area through steam sterilizer for sterilization.
Transfer the micro plate exposing stands to controlled area for further cleaning and sterilization.
Take out the unused hand gloves and destroy them. And send the remaining garment for rewashing and further sterilization.
Take out the remaining goggles and send them for further sanitization.
Replace the sterilium hand disinfectant bottles with fresh bottles.
Clean, sanitize & disinfect the aseptic are as per SOP.
Fumigate the aseptic area for 3 days continuously as per SOP after completion of media fill trials.
Visually inspect the sump, entry-exit airlocks, cross over bench, sampling room LAF, pass boxes, SS table, SS racks, other equipments, walls, ceiling, view panels and floor for cleanliness. If cleaning is not satisfactory than again perform the cleaning as per 5.4 and certify the area for cleanliness.
Inform the microbiology department personals to start monitoring of the area.
Perform surface monitoring.
Monitor the area after decontamination by settle plate and active air sampling.
Further aseptic processing shall be undertaken only after achieving area monitoring counts less than prescribed alert limit for 3 consecutive days.
Daily Controlled area cleaning after media fill trials
Clean and sanitize steam sterilizer, stand trolley as per SOP.
Extensive cleaning of steam sterilizer is to be done in following order.
Prepare 10.0 liters solution of the specified disinfectant in weekly rotation cycle in the required concentrations as per SOP.
Disinfect the sterilizer chamber and drains.
Clean the sterilizer chamber with hot (around 60o C) purified water using a lint free wipe.
Clean, sanitize and disinfect the controlled area as per SOP.
Controlled area cleaning after the media fill trial campaign.
Discard and dispose off the left over mannitol, vials and stoppers material.
Perform the control Daily area cleaning after media fill trials.
Clean the pre filter of Laminar Air Flow Units as per SOP.
Clean the steam sterilizer by following steps.
Record the details of cleaning and sterilization in respective equipment logbook and get it checked by the concerned supervisor / officer.
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History
