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.

Installation Qualification Protocol for Blister Packing Machine
Serial No.Item Description
1.0PROTOCOL APPROVAL
2.0OVERVIEW:
2.1Objective
2.2Purpose
2.3Scope
2.4Responsibility
2.5Execution Team
3.0ACCEPTANCE CRITERIA
4.0REVALIDATION
5.0INSTALLATION QUALIFICATION PROCEDURE
5.1Equipment Description
5.2Instruction for Filling the Checklist
5.3Installation Check-List
5.4Identification Of Major Components
5.5Identification of Supporting Utilities.
5.6Identification Of Safety Feature(s)
5.7Identification Of Standard Operating Procedure
5.8Identification Of Component to be Calibrated
5.9Verification of Drawings and Documents.
5.10Deficiency And Corrective Action(s) Report(s)
5.11Annexure (s)
6.0INSTALLATION QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final report approval
1.0PROTOCOL APPROVAL:

This Installation Qualification Protocol for Blister packing machine has been reviewed and approved by the following persons:

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PROJECTS / ENGINEERING  
REVIEWED BY PRODUCTION  
APPROVED BY QUALITY ASSURANCE  
2.0OVERVIEW :
2.1OBJECTIVE: 
 To perform the Installation Qualification of the Blister packing machine to be used for the Primary packing of tablets.
2.2PURPOSE: 
 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.
2.3SCOPE: 
 The Scope of this protocol is limited to the Installation Qualification of the Blister packing machine XYZ Pharmaceuticals.
2.4RESPONSIBILITY: 
 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
2.5EXECUTION TEAM:
 The execution team is responsible for the execution of this protocol. The execution team comprises of:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCEPTANCE CRITERIA:
3.1The equipment shall fulfill all the selection criteria and its individual application
3.2The equipment shall comply with the specifications mentioned in DQ.
3.3It shall comply with all the designed specifications.
3.4The Material Of Construction ( MOC) shall comply with the specification.
3.5All supporting utilities of specified capacities are to be near the place of installation
3.6All the specified installation checks are to be complied.
3.7All the related drawings and documents shall be checked and complied for availability and authenticity.
3.8All Standard Operating Procedures are to be identified.
4.0REVALIDATION 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
5.0INSTALLATION QUALIFICATION PROCEDURE
5.1EQUIPMENT DESCRIPTION:
Equipment NameBlister packing machine
Supplier / ManufacturerXYZ Company
Dimension (LXW)200 X 100 (or As per URS)
Volumetric capacity (Tab of max 10mm )2100 Tab/min (or As per URS)
Working Capacity300 Blisters/min (or As per URS)
Maximum PVC film width210 mm (or As per URS)
Maximum PVC film reel diameter440 mm (or As per URS)
Maximum Aluminium foil reel diameter206 mm (or As per URS)
Maximum aluminium foil width diameter210 mm (or As per URS)
Average power consumption7.5 KVA (or As per URS)
Air Pressure Required540 NI /min at 8 Kg/Sq. Cm (or As per URS)
Cooling water Flow Rate2 lit / min at 15 to 20 ºC (or As per URS)
ModelRotovac  -210V (or As per URS)
Serial no. (or As per URS)
LocationPrimary 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.  

5.2INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1In case of compliance of the test use the word ‘Complies’ otherwise use ‘Does not comply‘ to indicate non-compliance.
5.2.2For 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
5.2.3Give detailed information in the summary and conclusion part of the Installation Qualification report.
5.2.4Whichever column is blank or not used ‘NA’ shall be used.
5.3INSTALLATION CHECKLIST: The installation checklist is as follows: 
SR. NO.STATEMENTYES / NOCHECKED 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.   
07Safe 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.   
5.4IDENTIFICATION OF MAJOR COMPONENTS:
 Describe each critical component and check them and fill out the inspection checklist.
EquipmentsComponentsDesign SpecificationComplies / Does Not ComplyChecked By (Sign)Date
AC MotorBONFIGLIOI Star – Delta, 1HP/0.75Kw, 1500 RPM   
Gear BoxReduction 10:1 A – 162   
Temperature controller (PHR)PXW 40 AY2-1 BC75   
Temperature controller (PSR)PXW 40 AY2-1 BC75   
PLCMake: XYZ Company, Fx2N-64Mt   
MMIBEJAR E615   
InvertorXYZ Company   
VibratorVibromex 230 V   
Color sensorVisolux 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 GaugeFesto 0 to -1 Bar   
Infeed Motor  Remi ( 1/ 20 HP)    
5.5IDENTIFICATION OF SUPPORTING UTILITIES:
UTILITYPROPERLY 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   
5.6IDENTIFICATION OF SAFETY FEATURES  :
 Identify and record the safety features (if any) and their function in the following tables :
Safety Features DescriptionFunctionIdentified By (Sign)Date
1. Safety guard The machine will stop if not locked properly.   
2. EarthingTo avoid electrical shocks due to leakage current.  
3. Emergency stop buttonTo stop the machine if the problem appears in running condition.  
4. Micro switch for PVC filmThe machine will not operate if the PVC  roll is finished.  
5. Hopper lidTo prevent the entry of dust or any foreign particles in the hopper  
5.7IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for effective performance.
1Operation of Blister packing machine
2Cleaning of Blister packing machine
3Preventive maintenance of the Blister packing machine
5.8IDENTIFICATION OF COMPONENT TO BE CALIBRATED
1. Temperature sensors
2. Pressure gauges
5.9VERIFICATION OF DRAWING AND DOCUMENTS:
 The following documents are reviewed and attached as listed below:
Sr. No.DRAWING AND DOCUMENT DETAILCHECKED BY (SIGN)DATE
    
    
    
    
    
    
    
    
    
    
    
5.10DEFICIENCY 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
   
   
   
   
   
   
   
   
   
   
6.0INSTALLATION QUALIFICATION FINAL REPORT:
6.1SUMMARY:
 
 
 
 
 
 
 
6.2CONCLUSION :
 
 
 
 
 
 
 

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.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  

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