HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 1 of 6
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 Installation qualification specification 3-4
9.0 Deficiency or Corrective action report 4
10.0 Construction 4-5
11.0 Safety requirements 5
12.0 List of spare parts 5
13.0 Summary and conclusion 5
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 2 of 6
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 installed in accordance with design qualification.

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

3.0 RESPONSIBLITIES:
3.1 QA responsible for generating the IQ 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-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 3 of 6
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 INSTALLATION QUALIFICATION PRE-REQUISITES:

6.1 Design qualification of Pass box
6.2 Supporting utilities
6.3 SOPs of cleaning, operation and maintenance of Pass box.
6.4 Cleanliness of area
6.5 Electric connections for installation
6.6 Check correctness of location of equipment with respect to layout.
6.7 Check correctness of mounting of equipment.

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 cover the body.

8.0 INSTALLATION QUALIFICATION SPECIFICATION

S. No. Parameters Design Criteria
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 4 of 6
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

fulfilled
specification
Yes/No
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
10 On/off switch for UV light
11 Door handles and hinges

Installed
Pass box
S. No. Location successfully
Asset #.
Yes/ No
01 Ophthalmic filling area-I
02 Ophthalmic filling area-II
03 Injectable manufacturing area
04 Ophthalmic manufacturing area

Checked by: Name: Sign:

Designation: Date:

Verified by: Name: Sign:

 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 5 of 6
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

Designation: Date:

9.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

(If any)

10.0 CONSTRUCTION:
Fan: permanently lubricated, centrifugal motor/ blowers.
HEPA Filtration System with Pre-filter: HEPA filter(s) provide 99.99% typical
efficiency for particle sizes 0.3 microns. Washable pre-filter with 85% air resistance
extends the life of main filter.
Light Indicator: Red light indicates operation state and green light indicates that door
is open.
Door: Heavy-duty, stainless steel door assemblies are constructed with glass windows
permitting visibility.
UV Light: ensure decontamination of material.

11.0 SAFETY REQUIREMENTS

S. No. Activity
1 One Side door opens
2 Jumpers for door interlock
when door release button
pressed
3 Both doors closed
Action
The other side door is locked.
UV light OFF.
When one side door is opened,
the another side door is locked
for a period of 60sec.
UV light ON.

12.0 LIST OF SPARE PARTS

 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-046
TITLE: Issue # 01
Effective Date 11-05-2020
INSTALLATION QUALIFICATION OF PASS BOX Review Date 11-05-2024
Supersede # 00
Page 6 of 6
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

________________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

12.1 HEPA filter 0.3micron

12.2 UV light
12.3 Fluorescent lamp
12.4 Interlocking     
12.5 Door System
12.6 Washable pre-filter 85%
12.7 Centrifugal motor/Blower

13.0 CONCLUSION AND SUMMARY

The installation qualification of Pass box has been performed by IQ team. The IQ report
demonstrates that equipment has been/ has not been installed successfully and correctly.