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.

Equipment Name :	Pass Box
Equipment Model No.:	KPB
Equipment ID No.:	XYZ
Equipment Area :	Dispensed Packing Material
Equipment Manufacturer Name :	Envair Electrodyne Ltd.
Equipment Application:	To transfer material from classified area to non classified area and vice versa.
Report  Date :

REPORT APPROVAL:

	Prepared by	Checked by	Checked by	Checked by	Approved by
Signature
Date
Name
Department	Maintenance	Quality Assurance	Production	Head -Maintenance	Head – Quality Assurance

• OBJECTIVE:
  1. To provide the findings of installation, operational and performance qualification of Pass Box.   

• SCOPE:

• The report is applicable to Pass Box with equipment ID No. XYZ installed at Paithan site.

• RESPONSIBILITIES:
  • Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.
  • Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.
  • Production Officer/Executive: To execute qualification study in co-ordination with other departments.
  • Head Maintenance: To review the qualification documents.
  • Head Quality Assurance: To review and approve the qualification documents.

• EQUIPMENT DESCRIPTION:

• Refer page installation qualification protocol.

• PROCEDURE :

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

• Installation Verification Report

Sr. No.	Check point	Acceptance Criteria (Specification)	Observation	Checked by Sign/date
1.0	Visual inspection of the equipment.	Visually there should not be any abnormality.
2.0	Check the electrical cables for housing and anchoring.	Electrical cables shall be securely housed and anchored.
3.0	Check the electrical ports.	All electrical ports shall be cleaned.

• Technical Specification Verification Report

Sr. No.	Check  Points	Acceptance Criteria (Specification) *	Observations	Checked by Sign/date
1.0	Make	Envair Electrodyne Ltd.
2.0	Model	KPB
3.0	Indication lamp	01 No.
4.0	Electronic buzzer	01 No.
5.0	Tube Light	02 Nos.
7.0	Limit Switch	5 amps, 1 pols
8.0	Door interlocking solenoid coil	10 mm stroke, 230 V AC
9.0	Application	To transfer material from classified area to non classified area and vice versa.
10.0	Approximately Size (W x D x H)mm	1300 mm x 1100 (D) mm x 1400 (H) mm.

* As recommended by the manufacturer

Sr. No.	Check  Points	Acceptance Criteria (Specification) *	Observations	Checked by Sign/date
11.0	Type of cleaning	On line
12.0	Sealing Material	RTV sealant

* As recommended by the manufacturer

• Measuring Device Calibration Verification Report

Sr. No.	Measuring Devices	Acceptance Criteria	Instrument ID No.	Calibrated on Calibration Due	Observation	Checked by Sign/date
1.0	Multimeter	It should be found within its calibration period.

• Utility Verification Report

Sr. No.	Check  Points	Acceptance Criteria	Observation	Checked by Sign/date
1.0	Electricity	Single phase, 230 V AC ± 10% and 50 Hz ± 5%

• Safety Features Verification Report

Sr. No.	Safety Features	Acceptance Criteria	Observation	Checked by Sign/date
1.0	Edges / corners	Edges /corners shall be rounded.

Sr. No.	Safety Features	Acceptance Criteria	Observation	Checked by Sign/date
2.0	Electrical and electronic guard	Total enclosure for all electrical and electronic parts along with earthling shall be provided.
3.0	Door interlocking	Door interlocking shall be provided.

• Material of Construction (MOC) Verification Report

Sr. No.	Components	Acceptance criteria of MOC	Observation	Checked by Sign/date
1.0	Main body	SS 304
2.0	Side Panel	SS 304
3.0	Hardware	SS 304

• Operational and Performance Verification Report

Sr. No.	Operation	Acceptance criteria	Observation	Checked by Sign/date
1.0	Open the door from non classified area to pass the material.	Classified room side door shall be locked with visual indication.
2.0	Close the door from non classified area.	Audio visual indication shall be generate from the classified area. (i.e. to take out the material)
3.0	Press the push button provided at classified room side.	Buzzer shall be switched off and door get unlocked.

• DEVIATIONS:

Sr. No.	Deviation(s)	Justification for acceptance criteria	Impact on Installation Operation and Performance

• CHANGE CONTROL: If any shall be mentioned

• LIST OF ANNEXURE: Annexure number shall be mentioned

• SUMMARY AND CONCLUSION OF  QUALIFICATION:

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

CERTIFICATION OF QUALIFICATION:

Qualification is satisfactory.                                       Yes/No

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

Head-QA

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