Operational Qualification for Pass Box

Operational Qualification for Pass Box

TABLE OF CONTENTS

1.0 Approval
2.0 Objective
3.0 Responsibility
4.0 System Description
5.0 Pre-requisite of Operational Qualification
6.0 Operational Qualification Procedure
6.1 Training
6.2 Instrument Calibration
6.3 Key Functionality
6.4 Test Data Sheet
6.5 Safety Features Test
6.6 SOP Verification
7.0 Deviation and Corrective action
8.0 Change Control Proposal
9.0 Revalidation Criteria
10.0 Acceptance Criteria
11.0 Summary
12.0 Conclusion
13.0 Reference Documents

OBJECTIVE: –

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 it’s 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. 

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 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 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 its compliance to meet the acceptance criteria of the Operational Qualification protocol.

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

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 door interlocking system and minimum component of germicidal light may be fitted on optional basis. The pass box is provided with 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. 

PRE REQUISITE OF OPERATIONAL QUALIFICATION: –

  • Ensure the cleanliness of the area.
  • Equipment should be installed properly as defined in 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.

OPERATIONAL QUALIFICATION PROCEDURE: – 

Instructions:

  • A draft SOP’s shall be prepared on the basis of supplier guide for operation before the qualification testing.
  • Prior to 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 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 qualification test.
  • Operate the equipment / system as per the draft SOP’s, 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.

TRAINING: –

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

Title                                    :         Operational Qualification Procedure as per this protocol

Name of the Trainer(s)     :

Date of Training                :

S. No. Name of the Trainee Employee Number Signature

Signature of Trainer(s)      : ____________________

Date                                     : ____________________

INSTRUMENT CALIBRATION [Form – B]: –

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

S. No. Name of the Instrument Location Calibration

Done on

Calibration Due on Calibrated by
Not Applicable. Not Applicable.

  Checked By:                                                                                                          Verified By:

(Engineering)                                                                                                              (Q.A.)

  Sign / Date                                                                                                           Sign / Date

KEY FUNCTIONALITY: –

Purpose:

The purpose of this procedure is to demonstrate that the control panel and other manual operations of Pass Box (Tag No. POPSB-01) function as specified by the manufacturer.

Testing:

  1. Check all the displays on the panel are identified.
  1. Turn on the power from the electrical panel.
  1. Set the control(s) on the panel.
  1. Verify 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 unidirection flow on.
  • Red push button for unidirection flow off.
  • Observe and record the responses in the Testing Data Sheet.

TESTING DATA SHEET: – 

S. No. Test Particulars Specified Function Observations Checked By
1 Turn the power on to main machine. The feather touch screen will digitally display for THIS DOOR and OTHER DOOR will be showing C & C.    
2 Press the red de-magnetizing switch and pull the exit door. The digital display for THIS DOOR and OTHER DOOR will be O & C.    
3 Repeat the same with entry door. The digital display for THIS DOOR and OTHER DOOR will be O & C.    

SAFETY FEATURES TEST (If applicable): – 

S. No. Safety Feature Description Specified Function Observations Checked By
1 Lock the both doors and try to open any one of them with out pressing the de-magnetizing switch. Door will not open.    
2 In stand by position open both door and open the other door without closing first one. Door will not open due to door interlocking.    
3 Open both doors and run the Pass Box. Display will show O & O and alarm will beep.    

Checked By:                                                                                                          Verified By:

(Engineering)                                                                                                              (Q.A.)

  Sign / Date                                                                                                           Sign / Date

SOP VERIFICATION  

S. No. SOP Title Draft

SOP No.

Verification Date Operated By Observed By
1 Operating PO-SP-030-R00
2 Cleaning PO-SP-079-R00
3 Preventive Maintenance ER-SG-046-R00

 Comments:…………………………………………………………………………………………………………………………….

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

Verified by: ___________________                                                           Date: _____________

 

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 / Made Reason Verified By (Production)

Sign & Date

Approved By (Q.A.)

Sign & Date

REVALIDATION CRITERIA

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

ACCEPTANCE CRITERIA   

Operational 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: 

Checks Observations Remarks
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 Operational Qualification test as per the guideline described in this Protocol No. OQ / EQ / P /______ . Pass Box can Be / Not Be tested for its Performance Qualification as per Protocol No. PQ / EQ / P /________.

Verified by:    __________________                                        Date: _______________________

(G. M)

Verified by:    ___________________                                      Date:  ______________________

Q.A. Head

REFERENCE DOCUMENTS:- 

S. No. Document Name
01 Machine Operating Manual
02 Operational Qualification from CRP

 

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