HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 1 of 9
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 3
6.0 Installation qualification pre-requisites 3
7.0 Equipment design and principle of working 3-4
8.0 Installation qualification specification 4-5
9.0 Deficiency or Corrective action report 5
10.0 Construction 5-6
11.0 Safety requirements 6
12.0 List of spare parts 6
13.0 Summary and conclusion 6
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 2 of 9
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 air showers 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:

Air shower is a fully self-contained unit. They are fully equipped to provide complete de-
contamination solutions to the clean room or manufacturing/assembly area from
personnel entering the space.
Three Air showers has been purchased and their details are mentioned below:

Item Item Quantit PO No. Vendor Manufacturer

code Name y
FA-PMC- Air shower 03 13300581 Technocratic Shanzhen
0152 services Xiangnan High-
Tech Purify
Equipment Co,
Ltd. Hong Kong.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 3 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 4 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

5.0 LIST OF TEAM MEMBERS:

Members Designation Department

6.0 INSTALLATION QUALIFICATION PRE-REQUISITES:

6.1 Design qualification of Air shower
6.2 Utilities
6.3 SOPs of cleaning and operation of Air shower.

7.0 EQUIPMENT DESIGN AND PRINCIPLE OF WORKING:

7.1 The air shower properly designed and sized to maintain effective and efficient
operations.
7.2 At a minimum, HEPA filters are 99.99% efficient at 0.3 microns sufficient "wash
down time" - at least 30 seconds - must be allowed in the air shower. The air
supplied to the shower must be finely filtered to prevent personnel from being
impinged with contaminants during the actual cleaning cycle.
7.3 A fixed nozzle pattern must be followed and the nozzles must be preset to direct
air in a downward flow to produce shearing, wash down effect.
7.4 It is essential to have a fluttering of garments strong enough to loosen dust.
7.5 The air shower must operate at a negative pressure. In other words, the pressure
in the air shower must not exceed the pressure outside. The pressure must be less
than the cleanroom side to prevent contaminates.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 5 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

7.6 Very importantly, personnel must act responsibly, i.e., when they stand off-center
or crouch in a corner to avoid the air flow, they are defeating the whole purpose of
the air shower. The individual must center himself in the shower and execute
several complete 360º turns during the 30 second duration of the air shower, with
hands positioned over the head.

8.0 INSTALLATION QUALIFICATION SPECIFICATION

Air showers are self-contained chambers installed at entrance of injectable area or other
controlled environment to minimize the entrance or exit of particulate matter.

S. Parameters Design Specification Criteria fulfilled

No. Yes / No
1 Size (W x D x H) outer
2 Size (W x D x H) inner
3 Air velocity
4 Nozzle quantity
5 Air show time
6 Outer shell material
7 Inner shell material
8 Frame material
9 Door material
10 Baseboard material
11 Pre-filter
12 HEPA filter size
13 HEPA filter efficiency
14 Fan power (W)
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 6 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

15 LED power (W)

16 Power
17 Staff
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 7 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

Installed
S. Air shower
Model #. Location successfully
No. Asset #.
Yes/ No
01 XN-AS-1 Injectable filling area
02 XN-AS-1 Ophthalmic filling area- I
03 XN-AS-1 Ophthalmic filling area- II

Checked by: Name: Sign:

Designation: Date:

Verified by: Name: Sign:

Designation: Date:

9.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

(If any)

10.0 CONSTRUCTION
Fan: AC/ DC power, low vibration, low noise back centrifugal fan.
HEPA Filtration System with Pre-filter: HEPA filter(s) provide 99.99% typical
efficiency for particle sizes 0.3 microns.
Light Indicator: Two lights in a row. There is light on both side of box indicating the
location (open or close) of the door.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 8 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

Sound: Recorded voice message to intimate the door locking and unlocking during
showering process.
Door: Heavy-duty, stainless steel door assemblies are constructed with glass windows
permitting visibility.
LCD Display: The LCD displays shower duration and countdown, and reports cycle
progress and operational status.
LED Light: ensure uniform lighting throughout the chamber.
Stainless Steel Nozzles: An array of stainless steel nozzles direct high-velocity jets
within the chamber.

11.0 SAFETY REQUIREMENTS

11.1 Keep air shower area clean. Do not store any flammable material inside air
shower.
11.2 Do not lean any part of the body against an air nozzle.
11.3 Do not abuse equipment: Do not force doors open when locked, or try and
obstruct air passages (return air grilles, air nozzles, dampers, etc.) Abuse of the
equipment may cause damage and possible injury to occupants.
11.4 Check for damaged parts: Using this equipment in a disrepair state could result in
injury to personnel.
11.5 Replacement parts: When servicing, use only identical replacement parts.
11.6 Interlocked doors when equipment is being operated to insure personnel are not
injured by opening or closing doors.
11.7 Do not introduce any liquids into the air circulating system.

12.0 LIST OF SPARE PARTS

12.1 Air spray nozzles
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-IQ-045
TITLE: Issue # 01
Effective Date 04-05-2020
INSTALLATION QUALIFICATION OF AIR SHOWER Review Date 04-05-2024
Supersede # 00
Page 9 of 9
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation

12.2 HEPA Filter

12.3 LED Light
12.4 HMI
12.5 Door closer

13.0 CONCLUSION AND SUMMARY

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