Installation Qualification Protocol for Blister Packing Machine with Annexures

Learn about the Installation Qualification Protocol for Blister Packing Machine along with Annexures. The purpose of this protocol is to establish documentary evidence to ensure that the Blister packing machine received matches the Design specification and also to ensure that it is properly and safely installed.

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
5.0	INSTALLATION QUALIFICATION PROCEDURE
5.1	Equipment Description
5.2	Instruction for Filling the Checklist
5.3	Installation Check-List
5.4	Identification Of Major Components
5.5	Identification of Supporting Utilities.
5.6	Identification Of Safety Feature(s)
5.7	Identification Of Standard Operating Procedure
5.8	Identification Of Component to be Calibrated
5.9	Verification of Drawings and Documents.
5.10	Deficiency And Corrective Action(s) Report(s)
5.11	Annexure (s)
6.0	INSTALLATION QUALIFICATION FINAL REPORT
6.1	Summary
6.2	Conclusion
6.3	Final report approval

1.0	PROTOCOL APPROVAL:

This Installation Qualification Protocol for Blister packing 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 Installation Qualification of the Blister packing machine to be used for the Primary packing of tablets.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the  Blister packing machine received matches the Design specification and also to ensure that it is properly and safely installed.
2.3	SCOPE:
	The Scope of this protocol is limited to the Installation Qualification of the Blister packing machine XYZ Pharmaceuticals.
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 execution team is responsible for the execution of this protocol. The execution team comprises of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The equipment shall fulfill all the selection criteria and its individual application
3.2	The equipment shall comply with the specifications mentioned in DQ.
3.3	It shall comply with all the designed specifications.
3.4	The Material Of Construction ( MOC) shall comply with the specification.
3.5	All supporting utilities of specified capacities are to be near the place of installation
3.6	All the specified installation checks are to be complied.
3.7	All the related drawings and documents shall be checked and complied for availability and authenticity.
3.8	All Standard Operating Procedures are to be identified.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if:
	1. Any major changes affect the performance of the equipment. 2. After a major breakdown maintenance is carried out. 3. As per the revalidation date and schedule

5.0	INSTALLATION QUALIFICATION PROCEDURE
5.1	EQUIPMENT DESCRIPTION:

Equipment Name		Blister packing machine
Supplier / Manufacturer		XYZ Company
Dimension (LXW)		200 X 100 (or As per URS)
Volumetric capacity (Tab of max 10mm )		2100 Tab/min (or As per URS)
Working Capacity		300 Blisters/min (or As per URS)
Maximum PVC film width		210 mm (or As per URS)
Maximum PVC film reel diameter		440 mm (or As per URS)
Maximum Aluminium foil reel diameter		206 mm (or As per URS)
Maximum aluminium foil width diameter		210 mm (or As per URS)
Average power consumption		7.5 KVA (or As per URS)
Air Pressure Required		540 NI /min at 8 Kg/Sq. Cm (or As per URS)
Cooling water Flow Rate		2 lit / min at 15 to 20 ºC (or As per URS)
Model		Rotovac  -210V (or As per URS)
Serial no.		(or As per URS)
Location		Primary packing of tablets (Area Name)

Blister packing machine comprises of following components.

1. Hopper
2. Vibrator
3. Feed roller
4. Forming Roller(Assembly )
5. Feeding Box
6. Web guide track
7. Sealing Roller (Assembly)
8. Indexing roller
9. Guide roller
10. Machine panel & cover
11. Trim chute
12. Embossing Unit
13. Perforation Unit
14. Pack pick and place assembly
15. Batch Code printing unit
16. Punching station
17. Conveyer belt
18. Safety limit switch
19. Emergency switch 

The Blister packing machine Rotovac-210V is an automatic blister packing machine utilized to pack tablets in blister packs. It operates on compressed air-assisted forming and rotary sealing The PLC controls the multiple functions of the machine. The thermoforming material loaded on the reel feed is drawn by a motor and is fed to the pre-forming heater through a dancing arm. The pre heated base film moves on the forming station where the blister cavities are formed on plastic zed base film. The blister cavities are formed by Vacuum The formed blister web is wrapped around the indexing roller fed through a small guide plate. The batch coding is done by a pneumatically operated system from where the coded web is transferred to a mechanical-driven perforating station. These embossed and perforated webs are then transferred to the punching station through an indexing Unit operated mechanically. All the operational controls and sequences of the machine are arranged by a Man-Machine Interface mounted conveniently located in front of the machine and mechanical cams with a limit switch which determines the positional accuracy of the machine with the feed pack.  

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 Installation Qualification report.
5.2.4	Whichever column is blank or not used ‘NA’ shall be used.

5.3		INSTALLATION CHECKLIST: The installation checklist is as follows:
SR. NO.	STATEMENT		YES / NO	CHECKED BY (SIGN)	DATE
01.	Verify that the “As Built” drawing is complete and represents the design concept.
02.	Verify that major components are securely anchored and shockproof.
03.	Verify that there is no observable physical damage.
04.	Verify that there is sufficient room provided for servicing.
05.	Verify that all piping and electrical connections are done according to the drawings.
06.	All-access ports are examined and cleared of any debris.
07	Safe electrical connections.
08.	A wiring diagram affixed to the inside section of the control panel.
09.	Are Equipment identification nameplates visible?
10.	Units installed on the foundation are secure in place as per the manufacturer’s recommendations.

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	Describe each critical component and check them and fill out the inspection checklist.

EquipmentsComponents	Design Specification	Complies / Does Not Comply	Checked By (Sign)	Date
AC Motor	BONFIGLIOI Star – Delta, 1HP/0.75Kw, 1500 RPM
Gear Box	Reduction 10:1 A – 162
Temperature controller (PHR)	PXW 40 AY2-1 BC75
Temperature controller (PSR)	PXW 40 AY2-1 BC75
PLC	Make: XYZ Company, Fx2N-64Mt
MMI	BEJAR E615
Invertor	XYZ Company
Vibrator	Vibromex 230 V
Color sensor	Visolux DK 20, U8=10.30VDC
Pressure Gauge (FRC)	Festo 0 to 16 Bar TYP concentric
Pressure Gauge(RELEASE )	Festo 0 to 16 Bar TYP concentric
Pressure Gauge(SUCTION)	Festo 0 to 16 Bar TYP concentric
Pressure Gauge(SEALING )	Festo 0 to 16 Bar TYP concentric
Vacuum Gauge	Festo 0 to -1 Bar
Infeed Motor	Remi ( 1/ 20 HP)

5.5	IDENTIFICATION OF SUPPORTING UTILITIES:

UTILITY	PROPERLY IDENTIFIED & CONNECTED (YES/NO)	CHECKED BY (SIGN)	DATE
1. Electricity :3 Phase 440 Volts 50Hz
2. Compressed air 8kg/cm2
3. Chilled water 15- 20ºC

5.6	IDENTIFICATION OF SAFETY FEATURES  :
	Identify and record the safety features (if any) and their function in the following tables :
Safety Features Description		Function	Identified 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. Micro switch for PVC film		The machine will not operate if the PVC  roll is finished.
5. Hopper lid		To prevent the entry of dust or any foreign particles in the hopper

5.7		IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for effective performance.
1	Operation of Blister packing machine
2	Cleaning of Blister packing machine
3	Preventive maintenance of the Blister packing machine

5.8	IDENTIFICATION OF COMPONENT TO BE CALIBRATED
1. Temperature sensors 2. Pressure gauges

5.9	VERIFICATION OF DRAWING AND DOCUMENTS:
	The following documents are reviewed and attached as listed below:

Sr. No.	DRAWING AND DOCUMENT DETAIL	CHECKED BY (SIGN)	DATE

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

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

Description of deficiency :

Corrective action(s) taken :

Reviewed By:

Date:

5.11 Annexure(s):

Sr.No.	Annexure No.	Title of Annexure

6.0	INSTALLATION QUALIFICATION FINAL REPORT:
6.1	SUMMARY:
6.2	CONCLUSION :

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by this protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report, and 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 the Blister packing machine 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