SOP for sterilization of media.
Pharma Editor
October 16, 2016
Production
1,823 Views
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SOP for sterilization of media.
- Objective:
- To lay down a procedure for sterilization of media.
- Scope:
- This SOP is applicable for sterilization of media.
- Responsibility:
- Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP.
- Accountability:
- Production Head and QA Head shall be accountable for the compliance of SOP.
- Abbreviations
- 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 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 all the prepared media carboy in the Bung processor cum Steam Sterilizer as per validated loading pattern.
- Press the “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.3 on the MMI of the Bung processor cum Steam Sterilizer.Check and verify the standard parameter of sterilization of media on man machine interface (MMI) as per mentioned below:
- Set Parameter:
| Sr.No |
Parameters |
Set value of cycle |
| 1 |
Heat up 1 |
110.0 °C |
| 2 |
Heat up Hold 1 |
4 min |
| 3 |
Heat up 2 |
115.0 °C |
| 4 |
Heat up Hold 2 |
4 min |
| 5 |
Heat up 3 |
118.0 °C |
| 6 |
Heat up Hold 3 |
4 min |
| 7 |
Heat up control Band |
0.4 °C |
| 8 |
Sterilization Hold temperature |
122.0°C |
| 9 |
Sterilization Hold time |
60 min |
| 10 |
Temperature control Band |
0.2 °C |
| 11 |
Over shoot temperature |
124.0 °C |
| 12 |
Sterilization stop temperature |
120.9 °C |
| 13 |
Sterilization Reset temperature |
120.5 °C |
| 14 |
Process End pressure |
-0.050 Bar |
| 15 |
Exhaust ON |
5 sec |
| 16 |
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 sterilization of media 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 sterilized media carboy 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 media carboy in cooling zone (class 100) as per SOP.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
| Date |
Revision Number |
Reason for Revision
|
| – |
00 |
New SOP |
