Operation Qualification of Sterilizing and Depyrogenation Tunnel

Operation Qualification of Sterilizing and Depyrogenation Tunnel protocol aims to provide evidence that the installed Sterilizing and Depyrogenating tunnel will operate consistently within its full dynamic range as per the manufacturer’s specifications.

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	Verification of Component to be calibrated
5.9	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:

The signing of this approval page of the Protocol indicates agreement with the operational qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

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

2.0

OVERVIEW:

2.1	OBJECTIVE:
	The objective of developing and executing this protocol is to collect sufficient data pertaining to the Sterilizing and depyrogenating tunnel and define the Operational qualification requirements and acceptance criteria for the machine. The objective of the operational qualification is to prove that each operation proceeds as per design specification and the tolerances prescribed there in the document.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the Installation of Sterilizing and Depyrogenation Tunnel will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications and to demonstrate that the control panel and other manual operation of Sterilizing and depyrogenating tunnel provide the proper functionality as specified in the design qualification.
2.3	SCOPE:
	The Scope of this protocol is limited to the operational qualification of the Sterilizing and depyrogenating tunnel in Macleods Pharmaceuticals Ltd, at Nalagarh. The objective of developing and executing this protocol is to collect sufficient data pertaining to the Sterilizing and depyrogenating tunnel and define the qualification requirements and acceptance criteria for the machine. This protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the Sterilizing and depyrogenating tunnel operates and performs as intended in accordance with the design qualification.

2.4	RESPONSIBILITY:
	The following shall be responsible; ⭐ Department Head: Responsibility

2.5

EXECUTION TEAM:

The satisfactory operation of the Sterilizing and depyrogenating tunnel shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Sterilizing and depyrogenating tunnel is operational and is satisfactorily working. The execution team is responsible for the execution of the operation of the Sterilizing and depyrogenating tunnel. All individuals involved in executing this protocol must sign within the provided format as Given below:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The equipment must operate according to 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 MOC of the contact parts are to be checked as per the specifications.
3.5	All the functionality of equipment components to be checked.
3.6	All the safety features of the equipment shall be verified and utilities shall be available near the equipment.
3.7	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 machine has to be revalidated if:
	💡There are any major changes, which affect the performance of the equipment. 💡After major breakdown maintenance is carried out. 💡As per revalidation date and schedule.

5.0	OPERATIONAL QUALIFICATION PROCEDURE :

5.1
Equipment Name		Sterilizing and depyrogenating tunnel (10R)
Supplier / Manufacturer		Supplier Name
Overall Dimension (LXW)		1525(W) x 2340(H) x  3960(L) mm
Output		Output 240 molded & 300 Tubular 10 ml per minute
Model		V – 900 – H2 C3
Service it offers		Sterilizing and depyrogenating of vials
Location		XYZ

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	Whichever column is blank or not used ‘NA’ shall be used.

5.3	VERIFICATION OF FUNCTIONAL CHECKS:

TESTS	ACCEPTANCE CRITERIA	OBSERVATIONS	VERIFIED BY(SIGN)	DATE
1. Switch on the machine.	The machine should be operational.
2. Check machine parameters (availability of Purified water and Compressed air)  in manual mode.	The machine should be operational in manual mode.
3. Check Load empty bottle at infeed.	Smoothly loading of bottles in infeed.
4. Start   Auto Cycle and   Check. Smooth loading washing and unloading of bottles.	The machine should be operational in Auto mode with respect to the smooth loading washing and unloading of bottles.
5. Check the Functioning of operating parameters while washing trial.	All the operating parameters such as water pressure, and air pressure should be within in given limit.
6. Check the Functioning of the safety parameter.	All the interlocking systems should function.
7. Check the leakage in the gearbox,  mechanical variator, and Geneva  Mechanism.	No leakages in the gearbox, mechanical variator, and Geneva mechanism should be operational.
8. Check the vibration/noise-less operation of the machine drive unit.	Vibration/noiseless during operation.
9. Check the Variable speed of the Machine at minimum and maximum speed.	The machine should run smoothly.
10. Check operation of pumps	Water Pumps should be functioning  during operational

6.0 HEAT DISTRIBUTION STUDY EMPTY TUNNEL STERILIZER

OBJECTIVE

The objective of the test is to ensure that:

• The tunnel sterilizer when operated empty is capable of producing uniform temperature profiles, +/-10⁰C of the highest temperature set point set in the PLC of the equipment for the first heater bank.
• The temperature distribution is uniform throughout the sterilization period.
• Any location(s) where the temperature sensor is placed, not achieving minimum sterilization and depyrogenation temperature of 300⁰C during the sterilization period will be considered a cold spot.
• If sterilization temperature (300°C) is not achieved throughout the cycle, the temperature set points, conveyor speed, and zone pressures shall be reviewed and the cycle to be repeated.

LOAD DETAILS

• Empty Sterilizer Without Any Load

PROCEDURE

• Record the set parameters for the sterilization cycle to be operated during the test, in Annexure- 1.
• Placing a minimum16 number of temperature sensors shall carry out a heat distribution study of the empty sterilizer without load. Tie temperature sensors firmly to the SS zig in such a way that the tips of the temperature sensors are not touching any of the metallic surfaces.
• The placement of the temperature sensors shall be an equal distance from one another from the left to the right side of the conveyor belt of the sterilizing tunnel.
• Record the position of the temperature sensors in a representative schematic form in Annexure- 2.
• Connect the probes to a suitable data logger, which can scan and print the actual temperatures with respect to time.
• Operate the tunnel sterilizer as per SOP. No. also, start the data logger to record the actual temperatures within the sterilization zone with respect to time.

TEMPERATURE SENSOR PLACEMENT IN THE EMPTY TUNNEL STERILIZER

(NOTE: The temperature sensors shall be placed in the predetermined locations with predetermined sensor numbers corresponding to the data logger channels).

SENSOR NUMBER	LOCATION IN THE STERILIZER	SENSOR NUMBER	LOCATION IN THE STERILIZER
1	LEFT SIDE OF CONVEYOR	9	NEXT TO 8
2	NEXT TO 1	10	NEXT TO 9
3	NEXT TO 2	11	NEXT TO 10
4	NEXT TO 3	12	NEXT TO 11
5	NEXT TO 4	13	NEXT TO 12
6	NEXT TO 5	14	NEXT TO 13
7	NEXT TO 6	15	NEXT TO 14
8	NEXT TO 7	16	RIGHT SIDE OF CONVEYOR

 

JUSTIFICATION FOR THE TEMPERATURE SENSOR LOCATION CHOICE

• Sensor nos. 1 and 16 The conveyor belt side of the tunnel is the most critical area where there may be a possibility of a cold spot because the hot air re-circulation ducts are below the conveyor, near either conveyor edges.
• Sensor nos. 2 to 15- to verify the heat distribution across the conveyor belt from the left side to the right side.

When the sterilization cycle completes:

• Collect the strip chart from the multipoint temperature recorder of the tunnel control panel and also enclose the printout of the tunnel sterilizer along with Annexure-3
• Download the data from the data logger into the computer for data analysis and printing.
• Enclose the printouts obtained from the data logger in Annexure-4.

If the heat distribution study results are acceptable perform three consecutive replicate runs to demonstrate cycle and sterilizer reproducibility.

Compile the data generated during the operational qualification test to proceed for the Performance Qualification of Equipment.

Acceptance criteria

• There should be uniform temperature distribution across the conveyor belt during the sterilization hold period.
• The temperature at each temperature sensor should be within the range +/- 10⁰C of the maximum set point of the heater banks (1st heater bank) during the complete sterilization hold period.

Observations and results

Record the observations and results in formats.

Prepare summary report and enclose it along with Datalogger printouts.

5.6	VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were verified as important for the effective performance of Sterilizing and depyrogenating tunnel

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

5.7	TRAINING RECORD OF PERSONNEL (S) :

Sr. No.	Name of Personnel	Designation	Sign. & Date	Trained By	Remark

5.8	VERIFICATION OF COMPONENT (S) TO BE CALIBRATED

Verify that the drafted calibration procedures for different identified components in the Sterilizing and depyrogenating tunnel are adequate and appropriate covering the operating range(s). e.g. Pressure gauge, temperature gauge, temperature indicator cum controller, etc (As applicable). 

COMPONENT / PART TO BE CALIBRATED	SERIAL NO.	EXTERNAL CALIBRATION (ATTACH CERTIFICATE)	VERIFIED BY (SIGN)	DATE

5.9	DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S)

The following deficiency was verified and corrective actions were taken in consultation with the Engineering Department.

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 OQ Sterilizing and Depyrogenation Tunnel protocol are (Includes details), and attached (Mention attached documents).

The signature below confirms that everything in the operation qualification report for the Sterilizing and Depyrogenating tunnels has been reviewed and found acceptable. Any issues have been resolved satisfactorily.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE

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