- Objective:
- To lay down a procedure for sterilization of vial filling and bunging machine parts.
- Scope
- This SOP is applicable for sterilization of vial filling and bunging machine parts.
- Responsibility
- Production Officers/ Executive.
- Accountability
- Production Head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- Procedure
- Controlled Area Operation.
- Load the trolley with washed machine parts as per the attached validated loading pattern and diagram.
- Operate the sterilizer as per SOP.
| S.No. | Parameters | Set value in cycle |
| 01. | Pre vacuum | -0.500 bar |
| 02. | Pre pressure | 0.500 bar |
| 03. | No. of pre pulses | 3 |
| 04. | Heat up 1 / Hold 1 | 110 0 C / 5 min |
| 05. | Heat up 2 / Hold 2 | 115.0 0 C / 5 min |
| 06. | Heat up 3 / Hold 3 | 118.0 0 C /4 min |
| 07. | Heat up controlled band | 0.2 0 C |
| 08. | Sterilization hold temperature | 122.0 0 C |
| 09 | Sterilization hold time | 25 min |
| 10. | Temperature control band | 0.2 0 C |
| 11. | Overshoot temperature | 124 0 C |
| 12. | Sterilizations stop temperature | 120.9 0 C |
| 13. | Sterilization reset temperature | 120.5 0 C |
| 14. | Post vacuum | -0.700 bar |
| 15. | Vacuum hold time | 10 min |
| 16. | Post pressure | -0.100 bar |
| 17. | No. of post pulses | 3 |
| 18. | Process end pressure | -0.050 bar |
| 19. | Exhaust on | 5 sec |
| 20. | Exhaust off | 55 sec |
- On Completion of the cycle, check the cycle thermograph against the Master chart for Vial Filling & bunging machine parts load, for Temperature and time during the sterilization hold
- Check the temperature control chart for the steam sterilization cycle parameters.
- No. of Vacuum Pulses : 01
- Vacuum for Pulsing : -0.500 bar
- Steam Pressure for Pulsing : 0.500 bar
- Sterilization Temperature Range : 1210C to 1240C
- During Sterilization Hold Period
- Sterilization Hold Time : 25 minutes
- Sterilization pressure during : Not Less Than 1.110 bar
- Sterilization hold time
- Vacuum Cycle : 30 minutes
- If the thermograph of the cycle matches the Master chart, inform the Critical Area Personnel for unloading of the Sterilized Vial filling & bunging machine parts. Attach the Thermograph in the Batch Production Record (BPR)
- If the thermograph does not match the Master chart the cycle will be considered invalid. Do not unload the Vial Filling & bunging machine parts 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 Log book as per SOP and the Batch production record, get it checked by the Concerned Officer.
- Aseptic area operation
- Unload the trolley in cooling zone (class 100 area) containing the vial filling & bunging machine parts.
- Transfer the sterilized vial filling & bunging machine parts to the vial filling room through dynamic pass box (between cooling zone & vial filling room).
- 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
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