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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.
Verification of Key Functionality of Control Panel
5.6
Verification of Safety Features
5.7
Verification of Standard Operating Procedure
5.8
Verification of Component (S) to be calibrated
5.9
Training Record Of Personnel (S)
5.10
Deficiency And Corrective Action(s) Report(s)
6. 0
OPERATIONAL QUALIFICATION FINAL REPORT
6.1
Summary
6.2
Conclusion
6.3
Final 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.
1.0
PROTOCOL 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:
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 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.
2.2
PURPOSE:
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.
2.3
SCOPE:
TheScope 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.
2.4
RESPONSIBILITY:
The following shall be responsible: Departmental Head: Write their Responsibilities.
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 shall be operational as per its specified operating instructions.
3.2
All SOPs for the equipment shall be verified and checked.
3.3
Training is important to all the concerned personnel.
3.4
All the functionality of equipment components is to be checked.
3.5
All the safety features of the equipment shall be verified and utilities shall be available near the equipment.
3.6
The validity of the calibration of test instruments shall be checked and all the required calibration of the components of the equipment shall be performed.
4.0
REVALIDATION 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.
5.0
OPERATIONAL QUALIFICATION PROCEDURE:
5.1
EQUIPMENT DESCRIPTION:
Equipment Name
Automatic High-Speed Linear vial washing machine
Supplier / Manufacturer
Supplier Name
Model
Model Name
Capacity
150 vials per minute (5ml to 30ml)
Service it offers
Washing of vials.
Location
Vial washing Area (Block Name)
Washing Process Description:
No. of stage
Ten times washing
1st wash
Compressed air
2nd wash
Re-circulated water
3rd wash
Re-circulated water
4th wash
Compressed air
5th wash
Purified water
6th wash
Compressed air
7th wash
Purified water
8th wash
Compressed air
9th wash
WFI Water
10th wash
Compressed air
5.2
INSTRUCTION FOR FILLING THE CHECKLIST:
5.2.1
In case of the 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 the detailed information in the summary and conclusion part of the Operational Qualification report.
5.2.4
Whichever column is blank or not used ‘NA’ shall be used.
5.3
TEST 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 Instrument
Inst. ID. Number
Calibration valid up to
Checked by/Date
5.4
VERIFICATION OF FUNCTIONAL CHECKS:
NAME OF SYSTEM COMPONENT
SPECIFIED FUNCTION
OBSERVATION(YES / NO)
VERIFIED BY(SIGN)
DATE
1. Infeed conveyor
To take and keep the vials continuously for washing
2. Vial lifter/pusher guide
To give the individual vials into the individual vial pockets in opposite directions for washing.
3. Vial Pockets
To wash the individual vials with all the washing cycles.
4. Vial discharge guide
To take the washed vials from the pocket and keep them on the outfeed conveyor for further processing.
5. Outfeed conveyor
To proceed the washed vials continuously for the next process.
6. Spray Nozzle
To wash the vials with the required water and air
5.5
VERIFICATION OF KEY FUNCTIONALITY OF CONTROL PANEL:
OPERATING PANEL
Programmable Logic Controller
MAKE
Message
COMPONENT OF CONTROL PANEL
SPECIFIED FUNCTION
MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)
VERIFIED BY(SIGN)
DATE
1.Programmable logic control
1. Programmable logic control
2. Emergency switch
To stop the operation immediately at the time of emergency
3. Main switch ON/OFF
To supply the power to the machine
Features of key functions on MMI:
4. F1
Main drive ON/OFF should be display on MMI
5. F2
Pump 1 ON/OFF (WFI)
6. F3
Pump 2 ON/OFF (Purified water)
7. F4
Pump 3 ON/OFF (Recirculated water)
8. F5
UP (Speed)
9. F6
Infeed conveyor ON/OFF with extra conveyor ON/OFF
10. F7
Water level bypass
11. F8
Pump 4 ON/OFF (Purified/Silicon water)
12. F9
Down (Speed)
13. F10
Outfeed conveyor ON/OFF
14. F11
Manual mode
15. F12
Pump 4 bypass (Purified/Silicon water)
16. F13
Solenoid timer
17. F14
Help menu (all the details from F1 to F28)
18. F15
Auto mode
19. F16
Solenoid ON/OFF
20. F17
Prev. message
21. F18
Temp. status (WFI)
22. F19
Next digit
23. F20
Ack.
24. F21
Next message
25. F22
Incr. digit
26. F23
Spare
27. F24
Decr. Digit
28. F25
Spare
29. F26
Esc./Data
30. F27
Prev. Digit
31. F28
Enter
32. AUTO MODE OPERATION:
ON the main switch
The red, yellow, and Blue indicators should glow.
PLC/MMI indication
Machine details, Manufacturer details and model details, etc. should be on MMI after ON the main switch.
Press F15
No, any display should change on MMI.
First Press F1
The machine should start automatically and all the functions should be displayed ON on MMI.
Again Press F1
The machine should stop automatically and all the functions should be displayed OFF on MMI.
Pressure gauge for WFI
To 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 water
To monitor the pressure of Recycle water and should be functioned.
Pressure gauge for compressed air
To monitor the pressure of compressed air it should be functioned.
33. Manual mode operation:
Press F11
Status 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 F2
WFI pump should be ON
Press F3
P. Water pump should be ON
Press F4
Recycle water pump should be ON
Press F8
The purified water pump should be ON
Press F1
The machine drum should be ON
Press F6
Infeed conveyor should be ON/OFF automatically and extra conveyor should be on continuously. The feed conveyor should be start and stop automatically.
Press F10
Outfeed conveyor should be ON and continuously running.
5.6
VERIFICATION OF SAFETY FEATURES:
Description
Specified Function
Observation
DiscrepancyYes/No
Checked By/Date
Main switch ON/OFF
Power should be supplied into the machine only after ON the main switch.
In feed vial jam
When 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 jam
When 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 jam
When 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 jam
When 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 level
When any tank will be empty then machine should stop at once and display should be on PLC and Buzzer should be also ON.
5.7
VERIFICATION 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 TITLE
SOP NUMBER
VERIFIED BY
DATE
5.8
VERIFICATION 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 Instrument
Location
Calibration Certificate Available(Yes/No)
CalibrationDone on
Calibration Due on
01
Compressed Air pressure gauge
Connected to Filter housing
02
Re-circulated water pressure gauge
Connected to Filter housing
03
Purified water pressure gauge
Connected to Filter housing
04
Purified water pressure gauge
Connected to Filter housing
05
WFI pressure gauge
Connected to Filter housing
5.9
TRAINING RECORD OF PERSONNEL (S):
Sr. No.
Name of Personnel
Designation
Sign. & Date
Trained By
Remark
1.
2.
3.
4.
5.
5.10
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:
6.1
SUMMARY
6.2
CONCLUSION
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.
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