- To lay down a procedure for operation of Bung processor cum steam sterilizer.
- This SOP is applicable for operation of Bung processor cum steam sterilizer.
- Production operator / technician – responsible for Operation on Bung processor cum steam sterilizer.
- Production officer / Executive – to ensure that Operation on Bung processor cum steam sterilizer is carried out as per SOP.
- Production Head and QA Head shall be accountable for the compliance of SOP.
- SOP: Standard Operating Procedure
- WFI: Water for Injection
- MMI: Man Machine Interface PLC : Programmable Logic controller
- Check that the Bung processor cum steam sterilizer area and the chamber are visibly clean and no remnants of the previous load are present
- Open the valve of plant steam supply line and ensure that the plant steam pressure supplied to the autoclave in the pressure gauge is not less than 2 kg/cm².
- Open the valve on pure steam supply line and ensure that the pure steam pressure supplied to the autoclave in the pressure gauge is Not Less Than 2 kg/cm².
- Open the valve on purified water supply line and ensure that the purified water pressure supplied to the autoclave in the pressure gauge is Not Less Than 5 kg/cm².
- Open the valve on water for injection supply line and ensure that the water for injection pressure supplied to the autoclave in the pressure gauge is not less than 5 kg/cm².
- Open the valve on process air supply line and ensure that the process air supply pressure supplied to the autoclave in the pressure gauge is Not Less Than 0 kg/cm².
- Open the valve and ensure incoming Compressed air line is Not Less Than 0 kg/cm².
- Cleaning of the Bung processor cum steam sterilizer shall be done every day before start the machine as per SOP
- Automatic operation;
- Switch on the electric supply to control panel by selecting the key switch to ON position.
- Ensure that the aseptic area side door is closed as indicated by the indicator lamp on the control panel towards cooling zone.
- Ensure that the autoclave have passed the vacuum Leak Test performed as per SOP, before starting the sterilization cycle.
- Start the process recorder and enter the batch details in the MMI as described below :
- Batch Data
- Sterilizer No:
- Batch No.:
- Operator Code:
- Print Interval:60 sec
- Select the cycle No. on the control panel of the autoclave as per the respective SOP Nos
|Vacuum Leak Test|
|2||Bowie – dick Test|
|3||Sterilization of Media|
|Sterilization of Garments|
|Sterilization of Powder Filling Machine Parts & liquid filling machine parts|
|Sterilization of Miscellaneous components|
|5||Washing, siliconization and sterilization of Rubber stopper|
Sterilization of Cartridge filter
- On completion of the sterilization according to the set parameter, indicator of “process end” will glow and the process will stop, displaying the message ‘Batch stop’.Check the parameter in man machine interface (MMI) as per the Load cycle no. mentioned in respective SOP for the loaded material.
- Start the sterilization cycle by pressing the “START” push button on the control panel, simultaneously the process recorder will start automatically by displaying the message batch start (automatic)
- Check the thermograph of process recorder for the cycle parameter as per the respective SOP’s of the material being sterilized.
- On completion of the cycle and the aseptic area personnel unload the sterilized material.
- Aseptic AREA:
- After completion of cycle light of ‘process End’ is glow.
- Ensure that Non sterile side door is close before open the door of sterile side.
- Press the ‘St Door open’ switch to open door of sterile side then door is open slowly.
- Unload the sterilized material and press the ‘ST Door close’ switch to close the sterile side door. The door is close slowly.
- SHUT DOWN:
- After completion of process shut down the machine by key.
- Clean the machine as per SOP.
- Record the operation and cleaning details in the Equipment log book format and Batch Production Record and get it checked by the production officer/supervisor.
|Date||Load Description||Batch No||Operation||Preventive Maintenance /
|From||To||Operated By||Checked By||From||To||Done By||Checked By||From||To||Done By||Checked By|
REMARKS IF ANY:
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production
Date Revision Number
Reason for Revision
– 00 New SOP