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.

Related: IQ of High-Speed Linear Vial Washing Machine

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	Test Instrument Details
5.4	Verification of Functional Checks
5.5	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:
	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.
2.4	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.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE