HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-OQ-046
TITLE: Issue # 01
Effective Date 14-05-2020
OPERATION QUALIFICATION OF PASS BOX Review Date 14-05-2024
Supersede # 00
Page 1 of 4
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

TABLE OF CONTENTS
Sectio
Description Page No.
n
1.0 Objectives 2
2.0 Scope 2
3.0 Responsibilities 2
4.0 Equipment details 2
5.0 List of team members 2
6.0 Installation qualification pre-requisites 3
7.0 Equipment design and principle of working 3
8.0 Operation qualification specification 3-4
9.0 Deficiency or Corrective action report 4
10.0 Summary and conclusion 4
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-OQ-046
TITLE: Issue # 01
Effective Date 14-05-2020
OPERATION QUALIFICATION OF PASS BOX Review Date 14-05-2024
Supersede # 00
Page 2 of 4
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

1.0 OBJECTIVE:
Purpose of installation qualification is to ensure there is documented verification that the
equipment has been qualified for operational purpose.

2.0 SCOPE:
This operation qualification protocol is applicable to pass boxes in sterile area.

3.0 RESPONSIBLITIES:
3.1 QA responsible for generating the OQ protocol.
3.2 QA, QC, Production, Engineering are responsible for reviewing the protocol.
3.3 Director RA & QA responsible for approval of protocol.

4.0 EQUIPMENT DETAILS:

Dynamic Pass box is designed to obtain cleanliness level complies with Class 100/ISO-5
at rest condition and ability to sweep away contaminants generated during handling and
to maintain the required classified conditions.
Four Pass boxes have been purchased and their details are mentioned below:
Item Item Name Quantit PO No. Vendor Manufacturer
code y
FA-FFX- Pass box 02 13300580 Technocratic N/A
0255 (36”x24”36”) services
FA-FFX- Pass box 02 13300580 Technocratic N/A
0254 (42.5”x38.5”x78” services
)

5.0 LIST OF TEAM MEMBERS:

Members Designation Department
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-OQ-046
TITLE: Issue # 01
Effective Date 14-05-2020
OPERATION QUALIFICATION OF PASS BOX Review Date 14-05-2024
Supersede # 00
Page 3 of 4
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

6.0 OPERATION QUALIFICATION PRE-REQUISITES:

6.1 Ensure cleanliness of area.
6.2 Equipment should be installed as per IQ protocol of equipment.
6.3 All utilities connected properly and operational.
6.4 SOP of operation and cleaning of pass box.

7.0 EQUIPMENT DESIGN AND PRINCIPLE OF WORKING:

Vertical air pass through window/ Dynamic pass through window- with a vertical air
current, the wind come out from punch hole on two sides, which cause the flow in chaos
and whirlpool easily. It has low effect to get rid of the dust and bring the rising dust into
clean room easily. Vertical Dynamic pass through window is adopted fan, HEPA filter,
punch hole, and return wind system to compose the shower device. The fan produces a
high wind speed which is filtered by HEPA filter. Then forms a high speed clean air
current that comes out by multi-hole on top. The wind speed is more than 22m/s. Then
wind returns from the bottom of Dynamic pass through window. Due to vertical air
current, the velocity of air current at any spot keep accordance the air current press
down vertically likes a plunger to bring the dust particle which covers the body.

8.0 OPERATION QUALIFICATION SPECIFICATION

S. No. Test particulars Specified functions Observations
1 Turn the power on to main Machine will become
machine. operational
2 Pull the Entrance door. Door will open.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-OQ-046
TITLE: Issue # 01
Effective Date 14-05-2020
OPERATION QUALIFICATION OF PASS BOX Review Date 14-05-2024
Supersede # 00
Page 4 of 4
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

3 Repeat the same with exit door. Door will open.

4 Sterilization time under UV light. 60seconds.

S. No. Activity Action Observations

1 One Side door opens The other side door is
locked. UV light OFF.
2 Both doors closed UV light ON.

Checked by: Name: Sign:

Designation: Date:

Verified by: Name: Sign:

Designation: Date:

9.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

(If any)

10.0 CONCLUSION AND SUMMARY

The operation qualification of Pass box has been performed by OQ team. The OQ report
demonstrates that equipment has been/ has not been qualified successfully and correctly.