Operational Qualification for Pass Box

Pass Box

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 a door interlocking system and a minimum component of germicidal light may be fitted on an optional basis. The pass box is provided with a feather touch switch system for de-magnetizing. 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.

Operational Qualification for Pass Box


  • Approval
  • Objective
  • Responsibility
  • System Description
  • Pre-requisite of Operational Qualification
  • Operational Qualification Procedure
  • Training
  • Instrument Calibration
  • Key Functionality
  • Test Data Sheet
  • Safety Features Test
  • SOP Verification
  • Deviation and Corrective Action
  • Change Control Proposal
  • Revalidation Criteria
  • Acceptance Criteria
  • Summary
  • Conclusion
  • Reference Documents


The purpose of this protocol is: –

  • To qualify the equipment for its operational attributes.
  • To ensure that the major instruments identified in the Installation Qualification protocol are calibrated.
  • To establish that the Equipment operates within its desired operating ranges.
  • To assure that the Equipment serves the intended purpose.
  • To establish the suitability of the draft SOP prepared for the operation of Equipment.
  • To document the observations for future reference.


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 Operation of the equipment. The Production and Engineering shall be responsible for checking the operation and recording operational data as per the procedures outlined in this protocol. The Manager of Engineering shall be responsible for verifying the data recorded in the Operational 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 Operational Qualification protocol.

The final authorization of the document shall be done by the General Manager.


  • Ensure the cleanliness of the area.
  • Equipment should be installed properly as defined in the Installation Qualification protocol of the equipment.
  • All the utilities are connected properly and Operational.
  • All the Electrical connections are connected properly and Operational.
  • The training has been imparted to the Execution team for conducting Operational Qualification.



A draft SOP shall be prepared based on the supplier guide for operation before the qualification testing.

Before the qualification test, the personnel shall be trained by the engineer from the supplier on the operational features of the equipment/system this training shall be recorded.

Calibrate the instruments located on the equipment (as identified during installation) as per the in-house SOP of the instrument calibration or the manufacturer’s instruction. Record the date of calibration & due date.

The trained personnel shall carry out the Operational Qualification and record the observations of the qualification test.

Operate the equipment/system as per the draft SOPs, record the change if any, and confirm the SOP’s. Report the confirmation of SOP’s.

Report the deviations from the specified function, if any.


The execution team should be qualified for the Operation of the equipment by the supplier’s representative / qualified person.


Calibrate the instrument as identified below before the operation of the equipment. Attach the calibration record with this report.

No./Name of the Instrument/Location /Calibration Done on/Calibration Due on/Calibrated by



The purpose of this procedure is to demonstrate that the control panel and other manual operations of the PassBox function as specified by the manufacturer.


  • Check all the displays on the panel are identified.
  • Turn on the power from the electrical panel.
  • Set the control(s) on the panel.
  • Verify the functionality of each component on the control panel against its Specified functions.
  • Green push button for fluorescent light
  • Red push button for fluorescent light off.
  • Green push button for uni-direction flow on.
  • Red push button for unidirectional flow off.

Observe and record the responses in the Testing Data Sheet.


Turn the power on to the main machine.-The feather touch screen will digitally display for THIS DOOR and OTHER DOOR will show C & C.

Press the red de-magnetizing switch and pull the exit The digital display for THIS DOOR and OTHER DOOR will be O & C.

Repeat the same with the entry The digital display for THIS DOOR and OTHER DOOR will be O & C.


Safety Feature Description Specified Function

Lock both doors and try to open any one of them without pressing the de-magnetizing switch.-Door will not open.

In stand-by position open both doors and open the other door without closing the first one.-Door will not open due to the door interlock.

Open both doors and run the Pass Box -the Display will show O & O and the alarm will beep.


Verification Date//Operated By/Observed By

  • Operating SOP
  • Cleaning SOP
  • Preventive Maintenance SOP

Results: SOP Passes / Fails Verification Criteria and Recommended For Implementation & Review.


Description of deviation and date observed

The person responsible for corrective action and the date assigned

Corrective action taken and date conducted


Operation 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.
  • During monitoring if equipment is found to be malfunctioning.


Operational 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.


Whether acceptance criteria of the protocol and Specific checkpoints are met. Yes/No


Pass Box bearing  Is / Is Not qualifying for the Operational Qualification test as per the guideline described in this Protocol. Pass Box can Be / Not Be tested for its Performance Qualification as per Protocol.


  • Machine Operating Manual
  • Operational Qualification

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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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