Operational Qualification of Automatic High-Speed Linear Vial Washing Machine (Protocol)

The Automatic High-Speed Linear Vial Washing Machine protocol is designed to establish document evidence that the installed machine is operating as per the manufacturer’s specification.

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Related: IQ of High-Speed Linear Vial Washing Machine

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
5.3Test Instrument Details
5.4Verification of Functional Checks
5.5Verification of Key Functionality of Control Panel
5.6Verification of Safety Features
5.7Verification of Standard Operating Procedure
5.8Verification of Component (S) to be calibrated
5.9Training Record Of Personnel (S)
5.10Deficiency And Corrective Action(s) Report(s)
6. 0OPERATIONAL QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final Report approval

Equipment Details:

Equipment Name: Automatic High-Speed Linear Vial Washing Machine. (AHLVW 150)Equipment No.: EQI/XX/XXX/01
Protocol Reference No.                                    Report No.Page No.
1.0PROTOCOL APPROVAL:

This Operational Qualification Protocol for Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) 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 Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from washing machine) to be used for washing the various types of vials.
2.2PURPOSE: 
 The purpose of this protocol is to establish documentary evidence to ensure that the installed Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from washing machine) will operate reproducibly and consistently within its full dynamic range of operation according to manufacturer’s specifications.
2.3SCOPE: 
 The Scope of this protocol is limited to the Operational Qualification of an Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from washing machine) in XYZ Pharmaceuticals.
2.4RESPONSIBILITY: 
 The following shall be responsible:
Departmental Head: Write their Responsibilities.
2.5EXECUTION 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          
3.0ACCEPTANCE CRITERIA:
3.1The equipment shall be operational as per its specified operating instructions.
3.2All SOPs for the equipment shall be verified and checked.
3.3Training is important to all the concerned personnel.
3.4All the functionality of equipment components is to be checked.
3.5All the safety features of the equipment shall be verified and utilities shall be available near the equipment.
3.6The validity of the calibration of test instruments shall be checked and all the required calibration of the components of the equipment shall be performed.
4.0REVALIDATION CRITERIA:
 The Automatic High-Speed Linear Vial Washing Machine has to be revalidated if:
 ✔There are any major changes in system components that affect the performance of the system.
✔After major breakdown maintenance is carried out.
✔As per the revalidation date and schedule.
5.0OPERATIONAL QUALIFICATION PROCEDURE:
5.1EQUIPMENT DESCRIPTION:
Equipment NameAutomatic High-Speed Linear vial washing machine
Supplier / ManufacturerSupplier Name
ModelModel Name
Capacity150 vials per minute (5ml to 30ml)
Service it offersWashing of vials.
LocationVial washing Area (Block Name)
Washing Process Description: 
No. of stageTen times washing
1st washCompressed air
2nd washRe-circulated water
3rd washRe-circulated water
4th washCompressed air
5th washPurified water
6th washCompressed air
7th washPurified water
8th washCompressed air
9th washWFI Water
10th washCompressed air
5.2  INSTRUCTION FOR FILLING THE CHECKLIST:
5.2.1In case of the 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 the detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.
5.3TEST INSTRUMENT DETAILS
 This test is intended to describe the equipment/instruments and their complete details to have a traceability to the national standard which is to be used for the verification of the operation of the High-speed Linear vial washing machine.
Instrument/Equipment required:
1. Tachometer
2. Amperometer
3. Master pressure gauge                                 
Sr. No.Name of InstrumentInst. ID. NumberCalibration valid up toChecked by/Date
     
     
     
5.4VERIFICATION OF FUNCTIONAL CHECKS:
NAME OF SYSTEM COMPONENTSPECIFIED FUNCTIONOBSERVATION(YES / NO)VERIFIED BY(SIGN)DATE
1. Infeed conveyorTo take and keep the vials continuously for washing   
2. Vial lifter/pusher guideTo give the individual vials into the individual vial pockets in opposite directions for washing.   
3. Vial PocketsTo wash the individual vials with all the washing cycles.   
4. Vial discharge guideTo take the washed vials from the pocket and keep them on the outfeed conveyor for further processing.   
5. Outfeed conveyorTo proceed the washed vials continuously for the next process.   
6. Spray NozzleTo wash the vials with the required water and air   
5.5VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
OPERATING PANELProgrammable Logic Controller
MAKEMessage
COMPONENT OF CONTROL PANELSPECIFIED FUNCTIONMATCHES WITH THE SPECIFIED FUNCTION(YES / NO)VERIFIED BY(SIGN)DATE
1.Programmable logic control1. Programmable logic control   
2. Emergency switch To stop the operation immediately at the time of emergency   
3. Main switch ON/OFFTo supply the power to the machine   
Features of key functions on MMI:
4. F1Main drive ON/OFF should be display on MMI   
5. F2Pump 1 ON/OFF (WFI)   
6. F3Pump 2 ON/OFF (Purified water)   
7. F4Pump 3 ON/OFF (Recirculated water)   
8. F5UP (Speed)   
9. F6Infeed conveyor ON/OFF with extra conveyor ON/OFF   
10. F7Water level bypass   
11. F8Pump 4 ON/OFF (Purified/Silicon water)   
12. F9Down (Speed)   
13. F10Outfeed conveyor ON/OFF   
14. F11Manual mode   
15. F12Pump 4 bypass (Purified/Silicon water)   
16. F13Solenoid timer   
17. F14Help menu (all the details from F1 to F28)   
18. F15Auto mode   
19. F16Solenoid ON/OFF   
20. F17Prev. message   
21. F18Temp. status (WFI)   
22. F19Next digit   
23. F20Ack.   
24. F21Next message   
25. F22Incr. digit   
26. F23Spare   
27. F24Decr. Digit   
28. F25Spare   
29. F26Esc./Data   
30. F27Prev. Digit   
31. F28Enter   
32. AUTO MODE OPERATION:
ON the main switchThe red, yellow, and Blue indicators should glow.   
PLC/MMI indicationMachine details, Manufacturer details and model details, etc. should be on MMI after ON the main switch.   
Press F15No, any display should change on MMI.   
First Press F1The machine should start automatically and all the functions should be displayed ON on MMI.   
Again Press F1The machine should stop automatically and all the functions should be displayed OFF on MMI.   
Pressure gauge for WFITo monitor the pressure of WFI it should be functioned.   
Pressure gauge for P. water (Two)To monitor the pressure of P. water and should be functioned.   
Pressure gauge for Recycle waterTo monitor the pressure of Recycle water and should be functioned.   
Pressure gauge for compressed airTo monitor the pressure of compressed air it should be functioned.   
33. Manual mode operation:
Press F11Status Manual mode
Solenoid OFF 
Machine speed    
Temp. 000 C
Main drive OFF
All four pumps OFF
Infeed conv. and outfeed conv. OFF etc. details should be on MMI.
   
Press F2WFI pump should be ON   
Press F3P. Water pump should be ON   
Press F4Recycle water pump should be ON   
Press F8The purified water pump should be ON   
Press F1The machine drum should be ON   
Press F6Infeed conveyor should be ON/OFF automatically and extra conveyor should be on continuously.
The feed conveyor should be start and stop automatically.
   
Press F10Outfeed conveyor should be ON and continuously running.   
5.6VERIFICATION OF SAFETY FEATURES:
DescriptionSpecified FunctionObservationDiscrepancyYes/NoChecked By/Date
Main switch ON/OFFPower should be supplied into the machine only after ON the main switch.   
In feed vial jamWhen the vial will jam on this drum then machine should stop at once and display should be on PLC/MMI and Buzzer should be also ON.   
Lifter vial jamWhen vial will be jam on lifter at back side then machine should stop at once and display should be on PLC/MMI and Buzzer should be also ON.   
Pusher vial jamWhen vial will be jam on pusher at back side then machine should stop at once and display should be on PLC/ MMI and Buzzer should be also ON.   
Discharge vial jamWhen vial will be jam on discharging vial drum at back side then machine should stop at once and display should be on PLC/MMI and Buzzer should be also ON.   
Emergency stop (Front side cover)When push this button machine should stop at once.   
Emergency stop (Backside cover)When push this button machine should stop at once.   
Water levelWhen any tank will be empty then machine should stop at once and display should be on PLC and Buzzer should be also ON.   
5.7VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP):

The following Standard Operating Procedures were verified as important for the effective performance of the High-speed linear vial washing machine.

Sr. No.SOP TITLESOP NUMBERVERIFIED BYDATE
     
     
     
5.8VERIFICATION OF COMPONENT (S) TO BE CALIBRATED:

Verify that the drafted calibration procedures for different identified components in the High-speed Linear vial washing machine are adequate and appropriate covering the operating range(s).

S. No.Name of the InstrumentLocationCalibration Certificate Available(Yes/No)CalibrationDone onCalibration Due on
01Compressed Air pressure gaugeConnected to Filter housing   
02Re-circulated water pressure gaugeConnected to Filter housing   
03Purified water pressure gaugeConnected to Filter housing   
04Purified water pressure gaugeConnected to Filter housing   
05WFI pressure gaugeConnected to Filter housing   
5.9TRAINING RECORD OF PERSONNEL (S):
Sr. No.Name of PersonnelDesignationSign. & DateTrained ByRemark
1.     
2.     
3.     
4.     
5.     
5.10DEFICIENCY 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:
6.1SUMMARY
 
 
 
 
 
 
 
 
6.2CONCLUSION
 
 
 
 
 
 
 
 

6.3  FINAL REPORT APPROVAL

It has been verified that all tests required by the Automatic High-Speed Linear Vial Washing Machine (Protocol) are completed, reconciled, and attached to this protocol or included in the qualification summary report. 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 a High-speed Linear vial washing machine with two conveyor belts 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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