Blister Machine Operation Qualification Protocol/ Annexures

The purpose of Blister Machine Operation Qualification is to establish documentary evidence to ensure that the installed Blister pack machine 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 the Blister packing machine provide the proper functionality as specified in the design qualification.

Blister Machine Operation Qualification Contents:

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 Protocol No. (Format No.) 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		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

2.0	OVERVIEW :

2.1	OBJECTIVE:
	The objective of developing and executing Blister Machine Operation Qualification is to collect sufficient data about the Blister pack machine and define the 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 installed Blister pack machine 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 the Blister packing machine 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 Blister packing machine in XYZ Pharmaceuticals. This protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the blister packing machine operates and performs as intended by the design qualification.

2.4	RESPONSIBILITY:
	The following shall be responsible; Quality assurance officer/Executive  – For Preparation of Protocol /Execution Projects. Engineering Head – For execution. Production Head – For execution support. Quality Assurance Head – For adequacy and final approval

2.5

EXECUTION TEAM:

The satisfactory operation of the Blister pack machine shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Blister pack machine is operational and is satisfactorily working. The execution team is responsible for the execution of the operation of the Blister pack machine. All executors involved with this protocol shall sign within the prescribed format given below:

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	All material constructions of the contact parts are to be checked as per the specifications.
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 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 the revalidation date and schedule.

5.0	OPERATIONAL QUALIFICATION PROCEDURE:

5.1	Equipment description
Equipment Name		:	Blister packing machine
Supplier / Manufacturer		:	Rotovac  M/C -210V
Overall Dimension (LXW)		:	200 X 100
Working Capacity		:	2100 Tab/min
Model		:	Rotovac  -210V
Serial no.		:	XYZ
Location		:	Primary packing of tablets (Block –2)

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. Check the correct working of the machine.	The machine should be operational
2. Operate the machine as per its SOP. Check the proper blister formation, sealing, overprinting, and punching at 3-4.5m/min.	It should not exceed the set limit.
3. Check the working of all temperature controllers and pressure gauges.	It should control/indicate respective parameters accurately and consistently.
4. Noise level	It should not be more than 90 dB.
Test 1-Inter lock for no base material remove the base material and start the push button	The machine should not start.
Test 2-Emergency stopping of the machine start the machine. Press the emergency stop push button	The machine should stop immediately

TESTS	ACCEPTANCE CRITERIA	OBSERVATIONS	VERIFIED BY(SIGN)	DATE
Test 3-Blister forming by vacuum: 1. Check air pressure, cooling water, and base material.  2. Set the temperature between 140ºC and 160ºC.	Blisters of specified depth are formed at the forming station.
Test 4-Uniformity of the sealing of the formed web with the lidding material: 1. Place a carbon paper and a paper sheet over the counter sealing roller.  2. Stick them with adhesive tape to the counter sealing roller. Press the start push button to press the papers between the pressure sealing roller and the counter sealing roller. Repeat the test using the web and the lidding material.  3. Test the sealed web for leakage	A uniform impression of the counter sealing die and knurling of the pressure sealing roller on the paper is observed. No leakage is observed.

TESTS	ACCEPTANCE CRITERIA	OBSERVATIONS	VERIFIED BY(SIGN)	DATE
Test 5-Overprinting arrangement1.Mount Batch code printing drum.  2. Mount the stereo types over the drum.  3. Put a mixture of ink and thinner over the inking roller and engage the roller against the drum.  4. Press the start push button.	The Batch code printing drum is mounted. Drum and inking roller are engaged. No smudging of ink and no shifting of printing are observed.
Test 6-Perforation of the sealed web 1. Press the start push button.  2. The perforation tool gets engaged or disengaged with the web.	The web gets perforated as per layout.
Test 7-Embossing and punching of packs: 1. Mount the embossing typefaces in the punching/embossing station  2. Mount the hammer in the embossing station.	No shifting of printing is observed.
TESTS	ACCEPTANCE CRITERIA	OBSERVATIONS	VERIFIED BY(SIGN)	DATE
Test 8-Working of Temperature controller: 1. Switch on the temperature controller. Set temperature  2. controller between 120ºC and 140ºC. Run the machine.	Temperature is within the set limit.
Test 9 –Leak test on sealed packs – 1. Collect 20 successively sealed blister packs from each track. And dip it in the desiccator. 2. Start the vacuum pump and set the vacuum at –15 inches of mercury.  Keep the blisters for 1 minute and observe the blisters for any leakages.	All the blister packs should be free from leakages.

5.4:

OPERATING PANEL	PLC- OPERATED
MAKE	Rotovac-210 V

COMPONENT OF CONTROL PANEL	SPECIFIED FUNCTION	MATCHES WITH THE SPECIFIED FUNCTION(YES / NO)	VERIFIED BY(SIGN)	DATE
1. Machine ON-OFF indicator.	Red Indicator- Power on Green indicator-Machine on.
2. Forming roller temperature indicator.	To indicate the temperature of the forming roller. Set the roller temperature and record: At 50°C: At 100°C: At 150°C: At 190°C.
3. Sealing roller temperature indicator.	To indicate the temperature of the sealing roller. Set the roller temperature and record: At 50°C: At 100°C: At 150°C: At 190°C.

5.5	VERIFICATION OF SAFETY FEATURE (S):

SAFETY FEATURES DESCRIPTION	FUNCTION	VERIFIED BY(SIGN)	DATE
1. Safety guard	The machine will stop if not locked properly.
2. Earthing	To avoid electrical shocks due to leakage current.
3. Emergency stop button	To stop the machine if the problem appears in running condition.
4. Hopper lid	To prevent the entry of dust or any foreign particles in the hopper

5.6	VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were verified as important for the effective performance of Blister packing machine operation.

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 Blister packing machine 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
1. Temperature Controller -Forming
2. Temperature controller – Sealing
3. Pressure gauge – Air regulator
4. Vacuum gauge
5. Sealing gauge
6.  Vaccum suction gauge
7. Vaccum release gauge

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 Blister Machine Operation Qualification 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 shows that all items in this qualification report of the blister packing machine have been checked and found to be okay. Any differences or issues have been resolved satisfactorily.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE