Installation Qualification for Pass Box

Pass Box

A pass box is a component of a cleanroom setup designed to move materials from one side to another within a controlled setting to prevent contamination through the air. Its sole function is to transfer materials from one side to the other without causing any contamination issues, and it automatically removes any particles on the material’s surface during the process.

The key element of a pass box is its interlocking door system, which ensures that the door on one side remains closed while the other is open. It is also referred to by other names like cleanroom pass-through, clean transfer window, and transfer hatch.

Pass boxes come in two main types: static and dynamic. The main distinction between these two types is as follows:

DYNAMIC PASS BOX (DPB): A dynamic pass box is placed between areas that are classified and those that are not. It allows materials to be passed through vertically using HEPA-filtered air.

STATIC PASS BOX: a static pass box is installed only between two cleanroom areas and does not have any air supply or extraction systems. It is also referred to as a passive pass box and is equipped with UV light.

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 classifications. The product is provided with the minimum components of a Germicidal light and door interlocking system.

Installation Qualification for Pass Box

TABLE OF CONTENTS

  • Approval
  • Objective
  • Responsibility
  • Equipment Identification
  • Equipment location
  • Documentation
  • Pre-requisite of Installation Qualification
  • Installation Qualification Procedure
  • System Description
  • Procedure
  • Installation Check List
  • Inspection Checklist
  • Leveling and Alignment
  • Material of Construction CheckPoints
  • Guarantee / Warrantee Certificates
  • Drawing Execution
  • Identification of Standard Operating Procedures 
  • Supporting Utilities Check
  • Identification of Critical Instruments Calibration/Testing
  • Deviation and Corrective Action
  • Change Control Proposal
  • Revalidation Criteria
  • Acceptance Criteria
  • Summary
  • Conclusion

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 Procedures 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 of 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 their compliance to meet the acceptance criteria of the Installation Qualification protocol. 

EQUIPMENT IDENTIFICATION 

The Equipment is identified as a 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:- 

  • Data Sheet / User Requirement Specification
  • Purchase Order Copy
  • Design Qualification

 PREREQUISITE OF INSTALLATION QUALIFICATION: –

  • The machine should be open in front of the validation Team.
  • Ensure the cleanliness of the area.
  • Check the correctness of the location of the equipment to be installed concerning layout &
  • Check for correctness of mounting of equipment concerning manufactures recommendation.
  • Ensure the Electric connections required for installation.
  • Ensure the other supporting utilities are 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 record the installation location and verifier 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 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 assign SOP Numbers, and record the SOP Title and Number.
  • Record the deviation (if any) and report the details of the action taken. 

PROCEDURE : Installation Check List

  • Equipment Position concerning layout and room ID
  • All Electrical connections as per configuration
  • Door Interlocking System
  • Release Switch
  • Overall Dimension in mm. (W x D x H)
  • 900 x 850 x 950
  • Overall Dimension (Work Area) in mm. (W1 x D1 x H1)
  • 750 x 750 x 750
  • Doors :Make: CRP, MOC: S.S. 304
  • Door Handles :Type: “D”, Size: 4”, Make: CRP, MOC: S.S. 304
  • Key Pad with Feather touch switch :Make: CRP,
  • Push to release Switch : Range: 4A, 250V, Make: Elcom
  • Glasses -Type: Clear

Leveling and alignment: Pass Box – Spirit Level

Method for checking the Levelling 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 a 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 locations should match with the edges of those locations and, if required should be repeated for other edges of the equipment on the same plane.

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

Acceptance Criteria:

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

Material of Construction]

  • Cabinet: S.S. 304 – Lab Test Report / Confirmed by Molybdenum Test
  • Doors: S.S. 304 – Lab Test Report / Confirmed by Molybdenum Test
  • Viewing Window: Toughened Glass / Lab Test Report
  • Hinges & Handles: S.S. 304 / Lab Test Report / Confirmed by Molybdenum Test

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

  • Put 1 drop of the electrolyte solution of the Molybdenum test kit on the clean metal surface, which is to be tested.
  • Switch ON the detector and touch the metal tip of the detector on the metal surface and carbon point in the 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 the 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

Drawings Execution  

  • Wiring Diagram
  • Drawing for Pass Box

Identification of Standard Operating Procedures 

  • Operating – SOP for Operation of Pass Box
  • Cleaning- SOP for Cleaning of Pass Box
  • Preventive Maintenance – SOP for Preventive Maintenance of Pass Box

Supporting Utility Check 

Electrical – Power: 100W Approx., Voltage: 230 VAC, Current: 5A.

DEVIATION AND CORRECTIVE ACTION

  • Description of deviation and date observed
  • The person responsible for corrective action and the date assigned
  • Corrective action taken and date conducted

RE-VALIDATION CRITERIA

  • Installation Qualification to be re-qualified on
  • Replacement of a major component of the equipment with a new component.
  • Any major modification in the existing equipment.
  • 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 checkpoint shall be reported and the decision should be taken for the rejection, replacement, or rectification of the equipment/component. 

SUMMARY: 

Whether acceptance criteria of the protocol and Specific checkpoints are met.

CONCLUSION

Pass Box Is / Is Not qualifying the installation qualification test as per the guideline described in this Protocol. Pass Box can Be / Not Be tested for its operational qualification as per Protocol.

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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