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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)

A pharmaceutical chemist along with documents and a pen involving in Operation Qualification of Steam Sterilizer cum Bung Sterilizer

Content of Steam Sterilizer cum Bung Sterilizer OQ Protocol:

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

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

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECTS / ENGINEERING  
REVIEWED BY PRODUCTION                                          
APPROVED BY QUALITY ASSURANCE  
2.0OVERVIEW:
2.1OBJECTIVE: 
 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.
2.2PURPOSE: 
 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.
2.3SCOPE: 
 The Scope of this protocol is limited to the Operational Qualification of Steam sterilizer cum Steam sterilizer cum Bung sterilizer in XYZ Pharmaceuticals.
2.4RESPONSIBILITY: 
 The following shall be responsible;
Quality Assurance Officer/ExecutiveFor Preparation of Protocol /Execution Projects.
Engineering HeadFor execution.
Production HeadFor execution support.
Quality Assurance HeadFor adequacy and final approval.
2.5EXECUTION TEAM:
 The execution team is responsible for the execution of this protocol. The execution team comprises of:
DEPARTMENT DESIGNATION NAME SIGNATUREDATE  
 PROJECTS/ ENGINEERING          
 PRODUCTION          
 QUALITY ASSURANCE          
3.0ACCEPTANCE CRITERIA:
3.1The equipment should operate according to its specified operating instructions.
3.2We need to verify and check all standard operating procedures (SOPs) for the equipment.
3.3Training is important to all the concerned personnel.
3.4All MOC of the contact parts are to be checked as per the specifications.
3.5All the functionality of equipment components is to be checked.
4.0REVALIDATION 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.
5.0OPERATIONAL QUALIFICATION PROCEDURE:
5.1EQUIPMENT DESCRIPTION:
Equipment NameSteam sterilizer cum Bung Sterilizer
Supplier / ManufacturerPharmalab
Dimension Internal  (WXHXD mm)900 x 900 x 1200 mm
Volume972 liters
ModelPSSD334AB (H)
Job no.2006127
Service it offersSterilization 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.
5.2INSTRUCTION FOR FILLING THE CHECKLIST:
5.2.1In case of compliance of the test use the word ‘Complies’ otherwise use ’Does not comply‘ to indicate non-compliance.
5.2.2For 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.
5.2.3Give detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4Use ‘NA‘ in any column that is blank or not used.
5.3VERIFICATION OF FUNCTIONAL CHECKS:
NAME OF EQUIPMENT
COMPONENT		SPECIFIED FUNCTIONMATCHES 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
5.4VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
COMPONENT OF CONTROL PANELSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
1. Main SwitchTo start the machine.   
2. On-Off switchThe green indicator is for a run of the machine and the red indicator shows that the machine is off.   
3. GuardThe machine will trip if the guard is opened.    
5.5VERIFICATION OF SAFETY FEATURES:
SAFETY FEATURES DESCRIPTIONFUNCTIONVERIFIED BY(SIGN)DATE
1. Door SafetyThe door should not open during the process ON.  
2. Emergency offAll 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. EarthingTo avoid electrical shocks due to leakage current.  
5.6VERIFICATION 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 TITLESOP NUMBERVERIFIED BYDATE
1.    
2.    
3.    
4.    
5.7TRAINING RECORD OF PERSONNEL (S):
Sr. No.Name of PersonnelDesignationSign. & DateTrained ByRemark
1.     
2.     
3.     
4.     
5.     
5.8DEFICIENCY 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:

6.0OPERATIONAL 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.
6.1SUMMARY
 
 
 
 
 
 
 
6.2CONCLUSION
 
 
 
 
 
 
 

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.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  

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