HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-DQ-046
TITLE: Issue # 01
Effective Date 26-02-2020
DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
Supersede # 00
Page 1 of 4
PREPARED BY: REVIEWED BY: APPROVED BY:

_______________ _____________ _________________

A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
Affairs & QA

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 Design qualification pre-requisites 2
7.0 Equipment design and principle of working 3
8.0 Design qualification specification 3-4
9.0 Deficiency or Corrective action report 4
10.0 Conclusion & summary 4
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-DQ-046
TITLE: Issue # 01
Effective Date 26-02-2020
DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
Supersede # 00
Page 2 of 4
PREPARED BY: REVIEWED BY: APPROVED BY:

_______________ _____________ _________________

A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
Affairs & QA

1.0 OBJECTIVE:
Purpose of design qualification is to ensure there is documented verification that the
proposed design is suitable for the intended purpose.

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

3.0 RESPONSIBLITIES:
3.1 QA responsible for generating the DQ 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.

5.0 LIST OF TEAM MEMBERS:

Members Designation Department

6.0 DESIGN QUALIFICATION PRE-REQUISITES

6.1 URS of Pass box
6.2 Purchase order
6.3 Quotation
6.4 Specifications
6.5 SOPs of operation and cleaning of Pass box.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-DQ-046
TITLE: Issue # 01
Effective Date 26-02-2020
DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
Supersede # 00
Page 3 of 4
PREPARED BY: REVIEWED BY: APPROVED BY:

_______________ _____________ _________________

A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
Affairs & QA

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, and
return wind system to compose the shower device. The fan produces a high wind speed
which is filtered by HEPA filter. Efficiency of HEPA filter 99.99%. 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
quickly.

8.0 DESIGN QUALIFICATION SPECIFICATION

Vendor Compliance
S. No. Parameters URS
Specification status
1 Size (width x depth
x height) internal
2 Size (width x depth
x height) external
3 Material of
construction
4 Pre-filter
5 HEPA Filter
6 Quantity
7 UV light
8 Quantity
9 On/off switch for
blower
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-DQ-046
TITLE: Issue # 01
Effective Date 26-02-2020
DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
Supersede # 00
Page 4 of 4
PREPARED BY: REVIEWED BY: APPROVED BY:

_______________ _____________ _________________

A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
Affairs & QA

10 On/off switch for

UV light
11 Door handles and
hinges

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 design qualification of Pass box has been performed by DQ team. The specifications
provided in URS meets/ does not meet with vendor specification. Execution of Design
qualification states that intended purpose of proposed design has been/ has not been
fulfilled successfully.