- To lay down a procedure for sterilization of cartridge filter.
- This SOP is applicable for sterilization of cartridge filter pre assembled in filter housings.
- Production Officers / Executive.
- Production Head shall be accountable for the compliance of SOP.
- SOP : Standard Operating Procedure
- MMI : Man Machine Interface
- PLC : Programmable Logic Controller
- Controlled area operation
- Switch ON the machine with the key.
- Ensure that autoclave chamber is dry and temperature is ambient.
- Check the cleaning of chamber and all around the machine.
- Check the availability of soft water, pure steam, plant steam and compressed air.
- Check the pressure of compressed air should not be less then 6.0 kg/cm².
- Open the valve of plant steam supply line and ensure that the pressure of plant steam 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 pressure of pure steam supplied to the autoclave in the pressure gauge is Not Less Than 2 kg/cm².
- Load the cartridge filters pre assembled in filter housings in the Bung processor cum Steam Sterilizer as per validated loading pattern.
- Press the “NST door close switch” to close the door.
- Check the pressure of following mentioned below on front of the panel :
- Jacket Pressure : 0.0 Kg/cm²
- Sterile side gasket : 3.0 Kg/cm²
- Non sterile gasket : 3.0 Kg/cm²
- Chamber pressure : 0.0 Kg/ cm²
- Select the Cycle No. 6 on the MMI of the Bung processor cum Steam Sterilizer. Check and verify the standard parameter of cartridge filter cycle on man machine interface (MMI) as per mentioned below:
- Set Parameter:
|Sr.No||Parameters||Set value of cycle|
|1||Pre Vacuum||-0.500 Bar|
|2||Pre pressure||0.500 Bar|
|3||No of pre pulses||1 No|
|4||Heat up 1||110.0 °C|
|5||Heat up Hold 1||5 min|
|6||Heat up 2||115.0 °C|
|7||Heat up Hold 2||5 min|
|8||Heat up 3||118.0 °C|
|9||Heat up Hold 3||4 min|
|10||Heat up control Band||0.2 °C|
|11||Sterilization Hold temperature||122.0°C|
|12||Sterilization Hold time||25 min|
|13||Temperature control Band||0.2 °C|
|14||Over shoot temperature||124.0 °C|
|15||Sterilization stop temperature||120.9 °C|
|16||Sterilization Reset temperature||120.5 °C|
|17||Post vacuum||-0.700 Bar|
|18||Vacuum Hold Time||15 min|
|19||Post Pressure||-0.100 Bar|
|20||No of post pulses||1 No.|
|21||Process End pressure||-0.050 Bar|
|22||Exhaust ON||5 sec|
|23||Exhaust OFF||55 sec|
- On completion of the sterilization according to the set parameter, indicator of “process end” will glow on sterile side door and the process will stop, displaying the message ‘Process End’ on MMI.
- Check the cycle graph for cartridge Filters load for temperature and time during the sterilization hold.
- If the graph does not match the cycle will be considered invalid. Don’t unload the Cartridge Filters in the aseptic Area. Repeat the sterilization cycle. Inform the deviation to the Quality Assurance Department. Carry out the further processing as per the suggestions from the quality assurance
- Record the cycle details of Operation in the Equipment Logbook as per SOP and Batch production record, get it checked by the Concerned Supervisor / Officer
- Aseptic Area Operation :
- 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 and press the switch to open the sterile side door.
- Aseptic personnel unload the sterilized Cartridge Filters in cooling zone (class 100) as per SOP .
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP