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 Check list
- Leveling and Alignment
- Material of Construction Check Points
- 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 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:-
Document Name
Data Sheet / User Requirement Specification
Purchase Order Copy
Design 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
- Equipment Position with respect to 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
Levelling 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 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.
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]
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 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
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
Person responsible for corrective action and date assigned
Corrective action taken and date conducted
RE-VALIDATION CRITERIA
Installation Qualification to be re-qualified on
Replacement of 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 check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component.
SUMMARY:
Whether acceptance criteria of the protocol and Specific check points are met.
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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