- To lay down a procedure for sterilization of miscellaneous Items.
- This SOP is applicable for sterilization of Miscellaneous Items.
- Officers/above (Production-Injectable) is responsible for sterilization of Miscellaneous Items.
- Production Head is accountable for the implementation and compliance of this SOP.
- SOP : Standard Operating Procedure
- MMI : Man Machine Interface
- PLC : Programmable Logic Controller
- ltr : liter
- Controlled area operation
- Miscellaneous items load consists of following items: Pressure vessel 10 ltr, Pressure vessel 50 ltr, S.S. buckets, Sponge pieces, lint free duster, S.S. Spoons, S.S. forceps, scoop, Measuring cylinder, Exposure stands, silicon tubings, cartridge filters, housing of cartridge filters, S.S. trays, waste bins etc.
- Cartridge filters to be sterilized in miscellaneous Items load are air filters and disinfectant filtration filters used in the cooling room, No product filter should be sterilized in miscellaneous items load.
- 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 that pressure of compressed air should not be less than 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 all the miscellaneous Items in the Bung processor cum Steam Sterilizer as per validated loading pattern.
- Check all items as per “Checklist for miscellaneous items load”.
- 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 miscellaneous Items 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 miscellaneous Items 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 miscellaneous Items 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 operation time details in equipment log book as per SOP on equipment operation, cleaning and maintenance of log book – Injectable and get it checked by production officer
- Critical Area Operation :
- At the completion of sterilization cycle, light of Process End indicator will glow.
- Ensure that Non sterile side door is closed before opening the door of sterile side and press the switch to open the sterile side door.
- Aseptic area personnel shall unload the sterilized miscellaneous Items in cooling zone (class 100) as per SOP on Operation on Bung processor cum steam sterilizer.
- Forms and Records:
- Checklist for miscellaneous items load – Annexure-1
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP
Check list for miscellaneous items load
Load No :
|Sr. no||Items Description||Max Allowable Qty||Qty loaded||Loaded by||Checked by|
|1||Pressure vessel 20 ltrs.||1|
|2||Pressure vessel 50 ltrs||1|
|5||Lint Free duster||10|
|13||Housing for Cartridge filters||4|