Installation Qualification Protocol for Automatic Capsule Filling Machine

The purpose of the Installation Qualification Protocol for Automatic Capsule Filling Machine is to establish documentary evidence to ensure that the Automatic capsule filling machine system received matches the Design specification and also to ensure that it is properly and safely installed.

Installation Qualification Protocol for Automatic Capsule Filling 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
5.1System 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
5.8Test instrument details
5.9Identification Of Component to be Calibrated
5.10Verification of Drawings and Documents
5.11Abbreviations
5.12Deficiency And Corrective Action(s) Report(s)
5.13Annexure(s)
6.0INSTALLATION QUALIFICATION FINAL REPORT
6.1Summary
6.2Conclusion
6.3Final report approval
1.0PROTOCOL APPROVAL:

The signing of this approval page of the IQ Protocol for Automatic Capsule Filling Machine indicates agreement with the 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.

This Installation Qualification protocol for the Automatic capsule filling 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: 
 The objective of developing and executing this protocol is to collect sufficient data about the ‘Automatic capsule filling machine’ and define the qualification requirements and acceptance criteria for the Automatic capsule filling machine. Successful completion of these qualification requirements will ensure that the Automatic capsule-filling machine is installed as required in the production area. The objective of the installation qualification is to prove that each activity proceeds as per design specification and the tolerances prescribed there in the document and is the same at utmost transparency. 
2.2PURPOSE: 
 The purpose of this protocol is to establish documentary evidence to ensure that the Automatic capsule filling machine system received matches the Design specification and also to ensure that it is properly and safely installed. The purpose of Automatic capsule filling machine shall be used for capsule filling different capsule sizes to be used in the formulation. The equipment shall operate under a dust-free environment and conditions as per the GMP requirements.
2.3SCOPE: 
 This Protocol applies to the installation of an Automatic capsule-filling machine at the tablet manufacturing facility in Pharmaceuticals & the subsequent documentation.   
2.4RESPONSIBILITY: 
 The following shall be responsible;
Quality Assurance officer/ Executive – For the preparation of protocol.
Projects / Engineering Head – For execution.
Production Head – For execution support.
Quality Assurance Head – For adequacy and final approval
2.5EXECUTION TEAM:
 The satisfactory installation of the Automatic capsule-filling machine shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Automatic capsule filling machine was installed and is satisfactorily integrated. The execution team is responsible for the execution of the installation of the Automatic capsule filling machine. The execution team comprises of:
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS/ENGINEERING    
PRODUCTION    
QUALITY ASSURANCE    
3.0ACCETANCE CRITERIA:
3.1The Automatic Capsule Filling Machine shall meet the system description given in the design qualification.
3.2The Automatic Capsule Filling Machine shall meet the acceptance criteria mentioned under the topic “Identification of major components”.
3.3The Automatic Capsule Filling Machine system shall be operated by manual /PLC.

Related: Installation Qualification Protocol for Blister Packing Machine with Annexures

4.0REVALIDATION CRITERIA:
 The Automatic Capsule Filling Machine has to be revalidated if:
 Any major changes in system components affect the performance of the system. After major breakdown maintenance is carried out. As per the revalidation date and schedule.
5.0INSTALLATION QUALIFICATION PROCEDURE:
5.1AUTOMATIC CAPSULE FILLING MACHINE SYSTEM DESCRIPTION

PROCESS EQUIPMENT DESCRIPTION

The basic (Equipments) consists of the following subassemblies:

1. Structure Assembly:

This houses the main drive motor, powder drive motor, pneumatic and vacuum piping, all drive elements, and electrical control cabinet. The structure is enclosed on all four sides by removable covers. Removing the hand-wheel side cover exposes the filter regulator lubricator unit of the compressed air system, the pressure switch, and the main drive motor clutch. Removing the cover below the exit chute exposes the cam switch box and drive mechanism. When the cover located below the empty capsule loading area is removed, an electrical control panel is exposed.

2. Drive assembly:

This consists of the main motor, drive shaft, gears, cams, cam followers, bearings, housings, and brackets. Rotary indexing motion is given to the turret, dosing disc, and a reciprocating motion is given to various sections that move vertically by specially designed cams.

3. Turret Assembly:

The turret is a cylindrical disc. It has 8 pairs of cap and body bush holder plates with the cap plate located above the body plate. Each pair is radially equidistant around the turret center. The turret also houses a pneumatic cylinder and cams for providing motion to the cap and body bush holder plates.

4. Empty Capsule Holder Assembly:

This consists of a capsule hopper, capsule reservoir, magazine, rectifier block, horizontal finger assembly, and vacuum block. The reservoir has a baffle plate to regulate the flow of capsules in the reservoir. The magazine is mounted on a shaft. The vertical finger assembly and the capsule-releasing fingers are fitted on the magazine. A handle is provided to start or stop the release of capsules to the rectifier block. The released capsules are pushed by the horizontal finger assembly. A vacuum block located below the body bush holder plate moves up and down.

5. Powder Filling Device:

This consists of a hopper, stirrer, feed tube, powder level sensing device, and powder tub. The powder hopper is a stainless steel container fitted with an acrylic window. A powder stirrer is mounted centrally in the hopper and driven by a separate motor. At the delivery end of the hopper, an adjustable gate is provided to control the rate of powder flow and to facilitate the removal of powder at the end of the shift. The powder level in the powder tub is sensed by a capacitive-type proximity switch.

6. Tamping Station:

The product to be filled is fed from the hopper to the dosing disc. Due to the centrifugal force of the dosing chamber drive the product is carried to the outer edges of the dosing disc to the tamping plungers. The product is then compressed five times before being transferred into the capsule.

7. Pin Plate Assembly:

This consists of a plate on which various segments of pin for different applications are fitted. At No. 5 unopened capsules are collected in a box which are ejected out by pins. Similarly at stations 6,7& there are pins for the closing of capsules ejecting the capsule from the exit chute and cleaning of the capsule. 

8. Electrical control assembly:

This electrical control panel is mounted inside the structure of the machine. The mains ON / OFF switch is on the cover of the machine. The drive ON / OFF, control ON, speed regulator, and the emergency OFF. Switches are mounted on the pendent of the machine. Inching facility is provided for easy checking of the various settings on the machine. The display screen of the PLC has various selector keys for performing various operations. The control cabinet inside the structure houses the AC drive, The PLC, MCB`s contractors, and overload relays.

  PLC Description:

The main function of a PLC is to translate the instructions into the digital codes needed to operate the device or machine & to collect data from field instrumentation & display the information on the operator station. The instruments are connected to the system equipment. The collected data will be utilized by the PLC process control. The user interface, based on an industrial-type MMI. Will assist the operator in supervising and controlling the process. Based on the displayed information the operator, utilizing the user interface, can provide commands to the PLC. The PLC then executes the operator’s instructions. A Mitsubishi family FX 2 N 32 MT ESS PLC has been the central processing unit (CPU).

The PLC system layout for the automatic capsules filling machine automation is as shown below:

The PLC system layout for the automatic capsules filling machine automation
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.
5.2.2To identify the components of the equipment and utilities, use the word ‘yes’ to indicate their presence and use ‘no’ to indicate their absence.
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.

Related: Auto Coater Installation Qualification Protocol/ Annexures

5.3INSTALLATION CHECKLIST:
 The installation checklist is as follows:
Sr. NO.STATEMENTYES / NOCHECKED BY(SIGN)DATE
 Verify that the “As Built” drawing is complete and represents the design concept.   
 Verify that major components are securely anchored and shockproof.   
 Verify that there is no observable physical damage.   
 Verify that there is sufficient room provided for servicing.   
 Ensure that all piping and electrical connections adhere to the drawings.   
 All-access ports are examined and cleared of any debris.   
 Safe electrical connections.   
 A wiring diagram affixed to the inside section of the control panel.   
 Equipment identification nameplate visible.   
 Units installed on the foundation are secure in place as per manufacturer’s recommendations.   
5.4IDENTIFICATION OF MAJOR COMPONENTS:
 Describe each critical component and check them and fill out the inspection checklist.
System ComponentsDesign SpecificationChecked By(Sign)Date
1. Equipment DescriptionName —  
MaterialMild steel, painted, enclosed on all sides of SS 304 covers.  
Capacity25000/Hrs.  
ModelAF 25 T  
Serial No. —  
2. Drive AssemblyPosition —  
ManufacturerPAM India  
MaterialAlloy steel  
Timer beltHTD 8 mm pitch  
BearingsSKF / INA / IKO / RNST  
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
3. Turret Assembly     PositionCylindrical disc above  machine top, holding cap & body bush holder  
ManufacturerPAM India  
MaterialAluminium casting  
Surface finishElectroless nickel plated  
4.  Loader assemblyPositionAbove machine top plate to       load empty capsule in          bushes  
ManufacturerPAM India  
MaterialAluminium  
Surface finishBlack hard anodized  
Rectifier raceway & finger assemblyHalf-hard brass electro-nickel plate  
Reservoir & baffled plateSS 316, mirror-polished  
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
5. Powder filling devicePositionAbove machine top plate to provide powder for filling operation   
ManufacturerPAM India   
MaterialStainless Steel316L   
HopperSS 316, Mirror polish   
6. Pin plate assemblyPositionAbove machine top plate to perform various operations lick closing, ejection, bush cleaning removing unopened capsules.   
ManufacturerPAM India   
MaterialAlloy steel   
Surface finishElectro less nickel plated   
Open, closing, Ejection pinSS 316   
Bush cleaning pinBrass   
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
7. Limit switchQuantity4 Nos.  
SpecificationDoor safety switch 1 NO + 1NC  
ManufacturerEssendeinki – Made in India  
Model No.MBC 1  
Actuating force723 gms. (Max.)  
Release force170 gms. (Min.)  
Pre Travel1.5 mm (Max.)  
Over travel4.6 mm  
Movement differential0.08 mm  
Salient featuresSpring plunger actuator protected by a synthetic rubber cowl.  
8. Proximity switches
(Capacity) for
Capsule hopper   
SpecificationCapsule low-level switches   
Quantity1 No.   
ManufacturerIFM made in Germany   
Model No.KG5043 3008 BPK/IN   
Sensing range8 mm   
ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
9. Proximity switches (Capacity) for powder level   SpecificationPowder level switches  
Quantity1 No.  
ManufacturerIFM made in Germany  
Model No.KG5043 3008 BPK/IN  
Sensing range8 mm  
10. Proximity switches (inductive)  SpecificationTo provide signals for various operation  
PositionCam switch box  
Quantity2 No.  
ManufacturerTAP made in India  
Model No.GLP – 12APS  
Sensing range1 mm  
11. Proximity switches (inductive) for hand wheel    SpecificationTo provide signals for various operation  
PositionInside structure & near wheel shaft   
Quantity1 No.  
ManufacturerTAP made in India  
Model No.GLP – 12APS  
Sensing range1 mm  
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
12. Proximity switches (inductive) for the main motor     SpecificationTo provide signals for various operation  
PositionNear the main motor clutch  
Quantity1 No.  
ManufacturerTAP made in India  
Model No.GLP – 12APS  
Sensing range1 mm  
13. Proximity switches (inductive) for PMM motor     SpecificationTo provide signals for various operation  
PositionOn PMM motor gearbox  
Quantity1 No.  
ManufacturerTAP made in India  
Model No.GLP – 12APS  
Sensing range1 mm  
14. Filter regulatorSpecificationTo provide filtered air at a set pressure  
ManufacturerAirmatic Made in India  
Model No.MB 10 – 023  
Size6 mm  
Image for Describe each critical component and check them and fill out the inspection checklist.
Image-1 for Describe each critical component and check them and fill out the inspection checklist.
System ComponentsDesign SpecificationComplies / Does Not ComplyChecked By(Sign)Date
22. Door cylinderPositionPolycarbonate door   
ManufacturerMunjal Showa   
SpecificationStroke 175   
23. Pneumatic cylinderPositionInside turret well, exit chute   
ManufacturerRexroth Made in India   
SpecificationCompact cylinder 20 mm dia 4 mm stroke, DG 6-10, Part no. 3620, ADVU 20 x 10   
Operating range6 kg / cm2   
24. Pneumatic cylinder for capsule loadingPositionInside turret well, exit chute   
ManufacturerRexroth Festo Made in India   
SpecificationCompact cylinder 20 mm dia 10 mm stroke, ADVU – 20 – 10 – A, Part No. 156515.   
Operating range10 kg / cm2   
25. Pneumatic cylinder for group samplingPositionBelow Exit chute   
ManufacturerFesto   
SpecificationDG – 6 –10, 2620, T008, Dia10, 6 mm stroke   
Operating range6 kg /cm2   
26. Solenoid valvePositionOn pneumatic panel inside the structure   
ManufacturerFesto made in India   
SpecificationSingle solenoid MFH – 1- 1 / 8   
Operating range6 KG / CM2   
27. Timer beltPositionDrive assembly, Cam switch box   
ManufacturerOptibelt Made in Germany   
Specification8 mm pitch, 1200 mm length, 30 mm width, 150 teeth.   
28. ChainPositionDrive assembly, Cam switch box   
ManufacturerDiamond Simplex Made in India   
Specification½” Pith x 5 /16” roller dia, 33 link   
29. PLCCPU MakeMitsubishi Made Japan   
PositionInside the control panel   
Model No.F x 2N – 32 – MT   
PLC Input/output16 Input / 16 output   
30. A.C. drivesPositionInside the control panel   
ManufacturerMitsubishi   
  SpecificationFR – S520SE   
31. MMIMakeE 615   
PositionOn the pendant control box   
ManufacturerBeijers   
KeyboardTouch screen   
Serial interfaceRS – 232, RS 422   
Display5.7” Diagonal   
Supply voltage+ 24 VDC, ± 20 %   
32. Vacuum GaugeSpecificationFor operating  Air pressure 0 – 10 bar   
ManufacturerM / s SMC corporation   
Model No.I – I SE30 – 01- 65   
Accuracy0.1 – 1 KBP   
5.5                  IDENTIFICATION OF SUPPORTING UTILITIES:
UTILITYPROPERLY IDENTIFIED & CONNECTED (YES/NO)CHECKED BY (SIGN)DATE
1) Electricity: 3 Phase 440 Volts, 50Hz   
2) Compressed air: 6 kg/cm2   
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
    
  . 
    
    
    
5.7IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for the effective performance of the Automatic capsule-filling machine.
1.Operation of Automatic capsule filling machine.
2.Cleaning of Automatic capsule filling machine.
3.Preventive maintenance Automatic capsule filling machine.
5.8TEST INSTRUMENT DETAILS
 Instrument/Equipment required:
1. RPM-meter 2. Ammeter
5.9IDENTIFICATION OF COMPONENT TO BE CALIBRATED
In the High Shear Mixer Granulator, the following are the components, that need calibration. They shall be calibrated during/ before installation of the equipment at the site: Following are the components:
1. Pressure Measurement:
5.10VERIFICATION OF DRAWING AND DOCUMENTS:
 The following documents are reviewed and attached as listed below:
Sr. No.DRAWING AND DOCUMENT DETAILCHECKED BY (SIGN)DATE
1.   
2.   
3.   
4.   
5.   
6.   
7.   
8.   
9.   
10.   
11.   
5.11ABBREVIATIONS
 The following Abbreviations are used in the installation qualification protocol of the Air handling unit
 CMF: Capsule filling machine
MOC: Material of construction
RPM: Rotation per minute
BHP: Break horse power
HMI/MMI: Human/Man-Machine Interface
FAT: Factory acceptance test
CFM: Cubic Feet Per Minute
AISI: American Iron & Steel Institute
GEP: Good Engineering Practices
FLP: Flame Proof
MS: Mild steel
5.12DEFICIENCY 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

5.13 Annexure(s):

Sr.No.Annexure No.Title of Annexure
   
   
   
   
   
   
   
   
   
   
   
   
6.0INSTALLATION QUALIFICATION FINAL REPORT:
All the IQ data sheets and discrepancy reports shall be reviewed by the validation team to prepare a summary report. The summary of IQ shall be used to conclude approval of the installation qualification report.
6.1SUMMARY
 
 
 
 
 
 
 
6.2CONCLUSION
 
 
 
 
 
 
 

6.3 FINAL REPORT APPROVAL

Includes your Final Report Approval here.

NAMEDESIGNATIONDEPARTMENTSIGNATUREDATE
  PROJECTS / ENGINEERING  
  PRODUCTION  
  QUALITY ASSURANCE  

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