PASS BOX QUALIFICATION DOCUMENT

Equipment Equipment Number

Name
Protocol Effective Date
Number

TABLE OF CONTENTS
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

1.0 QUALIFICATION PRE – APPROVAL:

M/s. RC ENTERPRISES

--- Name of the Personnel Signature Date

Prepared By
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Reviewed By

M/s. VAJRA INDUSTRIES

Reviewed By

Approved By
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

2.0 Pass Box Introduction:

Pass box is one of the clean room systems, which is used to transfer materials from one side to
other side through controlled environment in order to avoid airborne cross contamination.

Pass box is used to transfer the material from lower cleanliness area to higher cleanliness area or
vice-versa in the classified area and also known as the hatch. Pass box works as a barrier between
two cleanliness level areas.
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Equipment Name:

Equipment Model No.:

Equipment ID No.:

Equipment Area:

Equipment Manufacturer Name:

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Equipment Application:

Report Date:  
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Reviewed by
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Name Signature Date

3.0 Installation Verification Report:

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Sr. Acceptance Checked by

Check point Observation
No. Criteria (Specification) Sign/date

Visual
Visually there should not
1.0 inspection of  
be any abnormality.
the equipment. 

2.0 Check the Electrical cables shall be  

electrical cables securely housed and
for housing and anchored.
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Sr. Acceptance Checked by

Check point Observation
No. Criteria (Specification) Sign/date

anchoring.

3.0 Check the All electrical ports shall be

   
electrical ports.  cleaned.

3.1 Technical Specification Verification Report

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Checked
Sr. Acceptance Criteria
Check Points Observations by
No. (Specification) *
Sign/date

1.0 Make    

2.0 Model KPB    

3.0 Indication lamp 01 No.    

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Checked
Sr. Acceptance Criteria
Check Points Observations by
No. (Specification) *
Sign/date

4.0 Electronic buzzer 01 No.    

5.0 Tube Light 02 Nos.    

7.0 Limit Switch 5 amps, 1 pol    

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Checked
Sr. Acceptance Criteria
Check Points Observations by
No. (Specification) *
Sign/date

Door interlocking
8.0 10 mm stroke, 230 V AC    
solenoid coil

9.0 Application To transfer material from    

classified area to non-
classified area and vice
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Checked
Sr. Acceptance Criteria
Check Points Observations by
No. (Specification) *
Sign/date

versa.

Approximately Size 1300mm x 1100 (D) mm

10.0    
(W x D x H)mm x 1400 (H) mm.

3.2 As recommended by the manufacturer

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Acceptance Criteria Checked by

Sr. No. Check Points Observations
(Specification) * Sign/date

Type of
11.0 Online    
cleaning

Sealing
12.0 RTV sealant    
Material

3.3 As recommended by the manufacturer

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

3.3.1 Measuring Device Calibration Verification Report

Checke
Sr. Measuring Acceptanc Instrument  Calibrated on  d by
Observation
No. Devices e Criteria ID No. Calibration Due Sign/
date

It should
1.0 Multimeter be found      
within its
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

calibratio
n period.

3.3.2 Utility Verification Report

Sr. Checked by
Check Points Acceptance Criteria Observation
No. Sign/date

1.0 Electricity Single phase, 230 V AC ±    

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

10% and 50 Hz ± 5%
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

3.3.3 Safety Features Verification Report

Sr. Checked by
Safety Features Acceptance Criteria Observation
No. Sign/date

1.0 Edges / corners Edges /corners shall be rounded.    

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Total enclosure for all electrical

Electrical and
2.0 and electronic parts along with
electronic guard
earthling shall be provided.

Door Door interlocking shall be

3.0
interlocking provided.

3.3.4
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

 Material of Construction (MOC) Verification Report

Sr. Acceptance criteria of Checked by

Components Observation
No. MOC Sign/date

1.0 Main body SS 304    

2.0 Side Panel SS 304    

3.0 Hardware SS 304    

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

4.0 Operational and Performance Verification Report:

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Sr. Checked by
Operation Acceptance criteria Observation
No. Sign/date

Open the door from Classified room side door

1.0 non-classified area shall be locked with visual    
to pass the material. indication.

Close the door from Audio visual indication shall

2.0    
non-classified area. be generated from the
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Sr. Checked by
Operation Acceptance criteria Observation
No. Sign/date

classified area. (i.e., to take

out the material)

Press the push

Buzzer shall be switched off
3.0 button provided at    
and door get unlocked.
classified room side.
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Reviewed by

Name Signature Date

5.0 DEVIATIONS:

Sr. Justification for Impact on Installation Operation

Deviation(s)
No. acceptance criteria and Performance
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

                         

                       

5.1 CHANGE CONTROL: If any shall be mentioned

5.2 LIST OF ANNEXURES: Annexure number shall be mentioned

6.0 SUMMARY AND CONCLUSION OF QUALIFICATION:

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Based on the Qualification what we have observed and whether it is suitable for use and
whether it passes all the criteria as mentioned in the Qualification Protocol shall be
mentioned

7.0 CERTIFICATION OF QUALIFICATION:

Qualification is satisfactory.                                       Yes/No

Hence equipment can be used for routine use.           Yes/No

Head-QA
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Reviewed by
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Name Signature Date

8.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

8.1 Description of deficiency and date observed
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Equipment Equipment Number
Name
Protocol Effective Date
Number

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8.2 Person responsible for corrective action and date assigned

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

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 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

8.3 Corrective actions taken and date conducted

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 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

SIGNATURES
Conducted By: Date:

Approved By: Date:

9.0 SUMMARY AND EVALUATION OF RESULTS

9.1
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

14.1 SUMMARY
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 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

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9.2 ANALYSIS / EVALUATION DATA

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 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

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 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

10.0 POST APPROVAL

10.1 Prepared by
The Signature indicates that the qualification protocol was executed and all tests
cases and discrepancies were properly documented.
NAME DESIGNATION SIGNATURE DATE
 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

10.2 Checked & Approved by

The signature indicates that the results have been reviewed and is in agreement
with those results and their conclusions

NAME DESIGNATION SIGNATURE DATE

 PASS BOX QUALIFICATION DOCUMENT
Equipment Equipment Number
Name
Protocol Effective Date
Number

Now the equipment is READY FOR PASS BOX QUALIFICATION.