Operation Qualification of Steam Sterilizer cum Bung Sterilizer (Protocol)

The purpose of the Operation Qualification of Steam sterilizer cum Bung sterilizer protocol is to establish documentary evidence to ensure that the installed Steam sterilizer cum Bung sterilizer will operate reproducibly and consistently within its full dynamic range of operation according to the specifications of the manufacturer.

Related Topic: Installation Qualification of Steam Sterilizer cum Bung Processor (Protocol)

Content of Steam Sterilizer cum Bung Sterilizer OQ Protocol:

SERIAL NO.	ITEM DESCRIPTION
1.0	PROTOCOL APPROVAL
2.0	OVERVIEW:
2.1	Objective
2.2	Purpose
2.3	Scope
2.4	Responsibility
2.5	Execution Team
3.0	ACCEPTANCE CRITERIA
4.0	REVALIDATION CRITERIA:
5.0	OPERATIONAL QUALIFICATION PROCEDURE
5.1	Equipment Description
5.2	Instruction for Filling the Checklist
5.3	Verification of Functional Checks
5.4	Verification of Key Functionality of Control Panel
5.5	Verification of Safety Feature (S)
5.6	Verification of Standard Operating Procedure
5.7	Training Record Of Personnel (S)
5.8	Deficiency And Corrective Action(s) Report(s)
6. 0	OPERATIONAL QUALIFICATION FINAL REPORT
6.1	Summary
6.2	Conclusion
6.3	Final Report approval

1.0	PROTOCOL APPROVAL:

This Operational Qualification Protocol of Steam sterilizer cum Bung sterilizer has been reviewed and approved by the following persons:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

2.0

OVERVIEW:

2.1	OBJECTIVE:
	To perform the Operational Qualification Steam sterilizer cum Bung sterilizer to be used for sterilizing the various types of dry goods products such as filter housing and cartridges, machine parts, textiles, rubber stoppers, products in pouches, products in ampoules or vials, etc.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the installed Steam sterilizer cum Bung sterilizer will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications.
2.3	SCOPE:
	The Scope of this protocol is limited to the Operational Qualification of Steam sterilizer cum Steam sterilizer cum Bung sterilizer in XYZ Pharmaceuticals.
2.4	RESPONSIBILITY:
	The following shall be responsible;
Quality Assurance Officer/Executive	For Preparation of Protocol /Execution Projects.
Engineering Head	For execution.
Production Head	For execution support.
Quality Assurance Head	For adequacy and final approval.

2.5	EXECUTION TEAM:
	The execution team is responsible for the execution of this protocol. The execution team comprises of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The equipment should operate according to its specified operating instructions.
3.2	We need to verify and check all standard operating procedures (SOPs) for the equipment.
3.3	Training is important to all the concerned personnel.
3.4	All MOC of the contact parts are to be checked as per the specifications.
3.5	All the functionality of equipment components is to be checked.

4.0	REVALIDATION CRITERIA:
	The Steam sterilizer cum Steam sterilizer cum Bung sterilizer has to be revalidated if:
	💡Any major changes in system components affect the system’s performance. 💡After major breakdown maintenance is carried out. 💡As per the revalidation date and schedule.

5.0	OPERATIONAL QUALIFICATION PROCEDURE:
5.1	EQUIPMENT DESCRIPTION:

Equipment Name	Steam sterilizer cum Bung Sterilizer
Supplier / Manufacturer	Pharmalab
Dimension Internal  (WXHXD mm)	900 x 900 x 1200 mm
Volume	972 liters
Model	PSSD334AB (H)
Job no.	2006127
Service it offers	Sterilization of machine parts, rubber stoppers, Garments, etc.

Steam sterilizer cum Bung sterilizer comprises of following components:

1. Validation gland adaptor 2. Sampling valve 3. Safety valve 4. Compound pressure gauge 5. 2-Way pneumatic valve 6. Pressure gauge 7. Air pressure switch 8. Air vacuum switch 9. Jacket pressure switch 10. Float-type steam trap 11. Pressure transmitter 12. Vacuum pump 13. Vent filter with housing 14. Air pressure regulator 15. Gasket air pressure regulator 16. Non return valve 17. Needle valve 18. Ball valve 19. Temperature sensor 20. Strainer 21. Solenoid valve 22. Door limit switch 23. Door safety switch 24. Printer 25. Chart recorder 26. Air agitation regulator with gauge 27. Float switch 28. Circulation water pump 29. Recirculation filter with housing 30. Drum motor 31. Dosing pump 32. Control panel

Steam sterilizer cum Bung processor is designed to sterilize various types of dry goods products such as filter housing and cartridges, machine parts, textiles, rubber stoppers, products in pouches, products in ampoules or vials, etc.

5.2	INSTRUCTION FOR FILLING THE CHECKLIST:
5.2.1	In case of compliance of the test use the word ‘Complies’ otherwise use ’Does not comply‘ to indicate non-compliance.
5.2.2	For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity.
5.2.3	Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4	Use ‘NA‘ in any column that is blank or not used.

5.3	VERIFICATION OF FUNCTIONAL CHECKS:

NAME OF EQUIPMENT COMPONENT	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION (YES / NO)	VERIFIED BY (SIGN)	DATE
1. Validation gland adaptor
2. Sampling valve
3. Safety valve
4. Compound pressure gauge
5. 2-Way pneumatic valve
6. Pressure gauge
7. Air pressure switch
8. Air vacuum switch
9. Jacket pressure switch
10. Float-type pressure switch
11. Pressure transmitter
12. Vacuum pump

13. Vent filter with housing
14. Air pressure regulator
15. Gasket air pressure regulator
16. Non return valve
17. Needle valve
18. Ball valve
19. Temperature sensor
20. Strainer
21. Solenoid valve
22. Door limit switch
23. Door safety switch
24. Printer
25. Chart recorder
26. Air agitation regulator with gauge
27. Float switch
28. Circulation water pump
29. Recirculation filter with housing
30. Drum motor
31. Dosing pump
32. Control panel

5.4	VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:

COMPONENT OF CONTROL PANEL	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
1. Main Switch	To start the machine.
2. On-Off switch	The green indicator is for a run of the machine and the red indicator shows that the machine is off.
3. Guard	The machine will trip if the guard is opened.

5.5	VERIFICATION OF SAFETY FEATURES:

SAFETY FEATURES DESCRIPTION	FUNCTION	VERIFIED BY(SIGN)	DATE
1. Door Safety	The door should not open during the process ON.
2. Emergency off	All output should get off except door gasket sealing if the emergency is pressed.
3. Control temperature sensor faulty.	If there is any problem with the control temperature sensor machine should stop.
4. Chamber safety against overpressure of the steam.	PLC should cut off the steam supply when the steam pressure is over.
5. Jacket safety against overpressure of the steam.	The safety valve should open when the steam pressure is over.
4. Earthing	To avoid electrical shocks due to leakage current.

5.6	VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP):

The following Standard Operating Procedures were verified as important for the effective performance of Steam sterilizer cum Bung sterilizer operation.

Sr. No.	SOP TITLE	SOP NUMBER	VERIFIED BY	DATE
1.
2.
3.
4.

5.7	TRAINING RECORD OF PERSONNEL (S):

Sr. No.	Name of Personnel	Designation	Sign. & Date	Trained By	Remark
1.
2.
3.
4.
5.

5.8	DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S):
The following deficiency was identified and corrective actions were taken in consultation with the validation team.

Description of deficiency:

Corrective action(s) taken:

 Reviewed By:

 Date:

6.0	OPERATIONAL QUALIFICATION FINAL REPORT:

The validation team to prepare a summary report shall review all the OQ data sheets and discrepancy reports. The summary of OQ shall be used to draw conclusion for approval of the installation qualification report.

6.1	SUMMARY
6.2	CONCLUSION

6.3 FINAL REPORT APPROVAL:

It has been verified that all tests required by the Steam sterilizer cum Bung sterilizer protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. It verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of Steam sterilizer cum Bung sterilizer have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE