Installation Qualification for Pass Box

Installation Qualification for Pass Box

TABLE OF CONTENTS

1.0Approval
2.0Objective
3.0Responsibility
4.0Equipment Identification
5.0Equipment location
6.0Documentation
7.0Pre-requisite of Installation Qualification
8.0Installation Qualification Procedure
9.0System Description
10.0Procedure
10.1Installation Check List
10.2Inspection Check list
10.3Leveling and Alignment
10.4Material of Construction Check Points
10.5Guarantee / Warrantee Certificates
10.6Drawing Execution
10.7Identification of Standard Operating Procedures 
10.8Supporting Utilities Check
10.9Identification of Critical Instruments Calibration/Testing
11.0Deviation and Corrective action
12.0Change Control Proposal
13.0Revalidation Criteria
14.0Acceptance Criteria
15.0Summary
16.0Conclusion

1.0            APPROVAL

 

Prepared BySignatureDate

 

Checked BySignatureDate

 

Approved BySignatureDate

 OBJECTIVE: –

The purpose of this protocol is to provide an outline for the inspection of equipment for static attributes to verify that:

  • The system meets the Design Specification / Qualifications.
  • The system is installed according to the manufacturer’s recommendations.
  • The system meets the current Good Manufacturer’s Practice (cGMP) requirements.
  • All supporting utilities are properly connected.
  • All critical components have been identified and calibrated.
  • No unauthorized or unrecorded modifications have taken place.
  • The equipment operation has been verified for its intended use.
  • Standard Operating Procedure have been identified and listed.

RESPONSIBILITY: –         

The validation group comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:

  • Engineering Department
  • Production Department
  • Quality Assurance Department

The Manager Plant shall be responsible for providing the area meant for the installation of the equipment. The Production and Engineering shall be responsible for checking the installation and recording installation data as per the procedures outlined in this protocol. The Manager Engineering shall be responsible for verifying the data recorded in the Installation Qualification Protocol.

The Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Installation Qualification protocol. 

EQUIPMENT IDENTIFICATION 

The Equipment is identified  as:Pass Box
Model No.:
Serial No.:
Tag No.:
Name of the Supplier:
Purchase Order Number / Date:

EQUIPMENT LOCATION 

Facility                            :                  Pharma Facility

Floor                               :                  Ground Floor

Area                                :                  Process Area

Room Name                   :                  Clean Room

Room ID                         :

DOCUMENTATION:- 

S. No.Document NameAnnexure No.
1Data Sheet / User Requirement Specification
2Purchase Order Copy
3Design Qualification

 PRE REQUISITE OF INSTALLATION QUALIFICATION: –

  • Machine should be open in front of validation Team.
  • Ensure the cleanliness of the area.
  • Check the correctness of location of the equipment to be installed with respect to layout &
  • Check for correctness of mounting of equipment with respect to manufactures recommendation.
  • Ensure the Electric connections required for installation.
  • Ensure the other supporting utilities required for Installation.

 INSTALLATION QUALIFICATION PROCEDURE

 Instructions:

  • Check the installation of equipment :
  • To verify the location of installation as per the equipment layout.
  • To verify the proper assembly of the components as per the equipment drawings and  record the installation location and verification of assembly
  • To check the leveling and alignment as per the procedure and record the observation.
  • Identify the critical components of equipment and verify that the components are complying as per desired specifications and record the observations.
  • Check the MOC of the component and record the observation of the MOC.
  • Identify the utility supplies required for equipment operation and verify that utilities are as per the specification and record the observation.
  • Identify the critical instruments supplied with the equipment or installed on the utility supply line. Verify that instruments are as per the desired specifications. Review the calibration status of the instruments & record the status.
  • List the available drawing and record the Ref. No. for their location / availability.
  • Identify the SOPs and assign SOP Numbers, record the SOP Title and Number.
  • Record the deviation (if any)  and report the details of action taken. 

SYSTEM DESCRIPTION

The static pass through hatch is used wherever transfer of material is required in between the clean room and non clean room or in between the clean room if different classification. The product is provided with the minimum components of Germicidal light and door interlocking system. When the product is in stand by position both the doors should be closed. When the doors are closed the digital display for THIS DOOR and OTHER DOOR will be showing C & C. To open the door press the release switch and pull the door handle. The door will get locked, the digital display for THIS DOOR and OTHER DOOR will be O & C.

PROCEDURE

Installation Check List

S. No.StatementY/ N / NAChecked By

Sign & Date

Verified By

Sign & Date

1Equipment Position with respect to layout and room ID   
2All Electrical connections as per configuration   
3Door Interlocking System   
4Release Switch   

 Y –        Yes,                                       N     –      No.                               NA       –       Not Applicable

Comments:_______________________________

Inspection Check List

S. No.DescriptionSpecificationObservation Checked By

Sign & Date

1Overall Dimension in mm. (W x D x H)900 x 850 x 950
2Overall Dimension (Work Area) in mm. (W1 x D1 x H1)750 x 750 x 750 
3DoorsMake: CRP

MOC: S.S. 304

785 x 785 x 43 mm.

Qty: 02 Nos.

 
4Door HandlesType: “D”

Size: 4”

Make: CRP

MOC: S.S. 304

Qty: 02 Nos.

 
5Key Pad with Feather touch switchMake: CRP

Model: CKP – GD – 01

Qty: 02 Nos.

 
6Push to release SwitchRange: 4A, 250V.

Make: Elcom

Qty: 02 Nos.

 
7Glasses450 x 450 x 4 mm.

Type: Clear

Make: Prakash Glass

Qty: 04 Nos.

 

Comments:_________________________

 Checked By:                                                                                                                 Verified By:

Sign / Date                                                                                                                    Sign / Date

 

Leveling and alignment  

S. No.Item DescriptionLeveling / Alignment

OK / Not OK

Mode of VerificationChecked By

Sign / Date

1Pass BoxSpirit Level

 A). Method for checking the Leveling of the Equipment

– Using Spirit Level Indicator

  • Place the spirit level indicator at different points on the machine frame.

Acceptance Criteria:

The air bubble of the spirit level indicator shall be observed in the center.

– Using Water Level Indicator

  • Place transparent tube filled with water of suitable length at various corners. Compare the levels of water and align the equipment

Acceptance Criteria:

The water level at both the locations should match with the edges of those locations, if required should be repeated for other edges of the equipment on same plane.

B). Method for checking the Alignment

  • Dial Indicator Method
  • Place the dial indicator on the coupling.
  • Rotate the shaft slowly by hand.
  • Observe the indicator reading on both sides’ rotation of the shaft.

Acceptance Criteria:

The total indicator reading should not be more than 0.305 mm.

–      Straight Edge Method

  • Place the straight edge along the circumferences of both driver and driven pulleys simultaneously.
  • Shift the motor base so as to adjust the gap between the straight edge and the circumferences of both the pulleys
  • Check the gap with filler gauge.

Acceptance Criteria:

The gap between the straight edge and pulleys should not be more than 1.0 mm

 Material of Construction]

CabinetS.S. 304Lab Test  Report / Confirmed by Molybdenum Test
2DoorsS.S. 304Lab Test  Report / Confirmed by Molybdenum Test
3Viewing WindowToughened GlassLab Test  Report
4Hinges & HandlesS.S. 304Lab Test  Report / Confirmed by Molybdenum Test

Method for checking Material of Construction (MOC) of Stainless Steel (SS) material (Molybdenum Test):

  • Put 1 drop of electrolyte solution of the Molybdenum test kit on clean metal surface, which is to be tested.
  • Switch ON the detector and touch the metal tip of the detector on metal surface and carbon point in electrolyte.
  • Do not pass the current for more than 3 to 4 seconds.
  • If the red color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 316
  • If the solution remains colorless or green color appears then it can be concluded that the material of construction of the part being tested is S.S. 304.
  • If the Black color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 302.

 Comments:_____________________________

 

Guarantee / Warrantee Certificate for Motors 

S. No.Component / Sub ComponentReport No.Annexure No.
1Not ApplicableNot ApplicableNot Applicable

 Drawings Execution  

Name of DrawingsDrawing No.Annexure No.Checked By

Sign & Date

Approved By

Sign & Date

Wiring DiagramNot Available
Drawing for Pass Box

 Comments:______________________________

Identification of Standard Operating Procedures 

S. No.SOP’sSOP’s No.TitleIdentified By / Date
1OperatingSOP for Operation of Pass Box
2CleaningSOP for Cleaning of Pass Box
3Preventive MaintenanceSOP for Preventive Maintenance of Pass Box

  Comments:____________________________

Supporting Utility Check 

S. No.UtilitySpecificationObservationChecked By

Sign & Date

Approved By

Sign & Date

1 ElectricalVoltage: 230 VAC

Power: 100W Approx.

Current: 5A.

 

Comments:__________________________________

Identification of Critical Instruments for Calibration / Testing 

S. No.ComponentParameter/ FunctionInstrument DetailsChecked By

Sign / Date

1Not ApplicableNot ApplicableNot Applicable

 Comments:_________________________________

 DEVIATION AND CORRECTIVE ACTION

 Description of deviation and date observed

Person responsible for corrective action and date assigned

 Corrective action taken and date conducted

Checked by:    __________________       Date: ____________________

Verified by:    ___________________     Date:  ____________________ 

 CHANGE CONTROL PROPOSAL 

Sr.Change Observed / MadeReason Verified By (Production)

Sign & Date

Approved By (Q.A.)

Sign & Date

RE-VALIDATION CRITERIA

Installation Qualification to be re-qualified on

Ø  Replacement of major component of the equipment with a new component.
Ø  Any major modification in the existing equipment.
Ø  Shifting of the equipment from one location to another.

ACCEPTANCE CRITERIA   

Installation Qualification shall be considered acceptable when all the conditions specified have been met.

Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component. 

SUMMARY: 

ChecksObservationsRemarks
Whether acceptance criteria of the protocol and Specific check points are met.
Yes/No

CONCLUSION

Pass Box bearing Tag No. ___________ Is / Is Not qualifying the installation qualification test as per the guideline described in this Protocol No. ______________. Pass Box can Be / Not Be tested for its operational qualification as per Protocol No. _______________.

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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