QUALIFICATION/ AIR BALANCING &

HEPA FILTER INTEGRITY ( DOP) TEST

REPORT OF HVAC SYSTEM

Report No. TS/3058/18

Tested On: May 2, 2018 Next Due date: May 1, 2019

Written by

______________
Erum Manzoor

Performed by

________________
[Link]

Checked by

__________________
Zahoor ilahi
Production Manager

Approved by

_______________
Ihtisham-ul-Haq
Manager Quality Control

EG PHARMACEUTICALS
PLOT# 13-A Industrial TRIANGLE, KAHUTA ROAD
ISLAMABAD
 Table of Content

Page
S. No. Content
No.

1.0 Objectives 1

2.0 Documentation 1

3.0 Environmental Performance Test 1

4.0 HVAC System 2

4.1 AHU No. 03 (Dry Washing Area) 2

4.2 AHU No. 16 (Ampoule Solution Preparation Area) 3

4.3 AHU No.17 (Infusion Filling Area) 3

4.4 AHU No.18 (Injection Filling Room) 4

4.5 AHU No.19 (Ampoule Filling Room) 5

4.6 AHU No.20 (Ampoule Washing) 5

4.7 Air Flow and Uniformity Test 6

4.7.1 Measurement of Air Volume in Supply and Return Air diffuser 6

4.7.2 Measurement of Differential Pressure Across the adjutant room 7

4.7.3 Measurement Of Air Velocity At Terminal HEPA Filter. 7

4.7.4 Measurement of Air Changes Per Hour 8

5.0 HEPA Filter Leakage Test 9

6.0 Temperature & Humidity Control Test 10

Calibration review 11
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1.0 OBJECTIVE:

The objectives of this report is

 To verify that the HVAC, supporting utilities and the circulation pump have been built and
installed in compliance with their design specifications.( IQ)
 To verify that the AHU, supporting utilities and the circulation pump operate in accordance
with their design specifications. (OQ)
 To verify that the AHU specific process will consistently produce a product meeting its pre
determined specifications and quality attributes. (PQ)
To verify the HVAC system meets the current Good Manufacturing Practices (cGMP)
requirements and all other regulatory obligations.
Particle concentration:
Number of individual particles per unit volume of air
Particle size distribution:
Cumulative distribution of particle concentration as a function of particle size

2.0 Documentation:

 Approved SOPs and test methods should be presented.

 In case of outside party services, the SOPs or Test methods should be duly signed by QA and
external service agency.
 Equipment should be calibrated.
 Calibration certificate of all relevant equipments or instruments should be provided.
 Identity number of all the equipment or instrument will be provided.
 All the annexure will be attached at the end of the protocol.

3.0 ENVIRONMENTAL PERFORMANCE TEST

Injectable,Vial & Ampoule Section were subjected to the following set of environmental
performance tests after completion of recommended changes per corrective action report.
- Air balancing of SAD
- Air balancing of RAD
- Air change per hour
- Differential pressure
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4.0 HVAC SYSTEM

Description:
Following key elements were considered for implementation and control of air the HVAC system
and air handling (AHU ) system in the overall design.
 Air flow regime
 Filtration
 Pressure differential across filters and areas
 Temperature
 Humidity
HVAC SYSTEM of Injectable area, vial & ampoule section containing the following AHU/HVAC
units;
4.1 AHU No. 03
AHU No.03 design and installed for terminal application ATTACHED AS Anexure# 1.
There are 04 supply air diffuser. AHU No. 03 serves the following location of Dry Washing Area
as shown in figure no. 1. There is about 04 supply air diffuser (SAD) and 02 return air grill
(RAG).

[Link]. OUTLET
AREA NAME
TYPE SIZE
01. VIAL WASHING S.A.D 12”x12”
02. BUFFER S.A.D 12”x12”

03. AIR LOCK S.A.D 12”x12”

04. CHANGE ROOM S.A.D 12”x12”

Sr. No. OUTLET

AREA NAME
TYPE SIZE
01. VIAL WASHING RAG 10”x10”

02. BUFFER RAG 10”x10”

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4.2 AHU No.16

AHU No.16 has been design and installed for terminal application and attached as annexure # 2.
There are 02 HEPA filters, which contain 99.997 % efficient (0.3 micron) HEPA filter. AHU No.
16 serves the following location of Ampoule Solution Preparation Area as shown in figure no. 1.
There is about 02 supply air diffuser (SAD) and 02 return air grill (RAG).
[Link]. OUTLET
AREA NAME
TYPE SIZE
01. PREPARATION ROOM S.A.D 22”x22”
02. PREPARATION ROOM S.A.D 22”x22”

Sr. No. OUTLET

AREA NAME
TYPE SIZE
01. PREPARATION ROOM RAG 14”x12”
02. PREPARATION ROOM RAG 14”x12”

4.3 AHU No. 17

AHU No.17 has been design and installed for terminal application and attached as annexure # 3.
There are 07 HEPA filters, which contain 99.997 % efficient (0.3 micron) HEPA filter. AHU No.
17 serves the following location of Infusion Filling Area as shown in figure no. 1. There is about
07 supply air diffuser (SAD) and 05 return air grill (RAG).
[Link]. OUTLET
AREA NAME
TYPE SIZE
01. INFUSION VIAL FILLING ROOM S.A.D 22”x22”
02. INFUSION VIAL FILLING ROOM S.A.D 22”x22”
03. INFUSION VIAL FILLING ROOM S.A.D 22”x22”
04. INFUSION VIAL FILLING ROOM S.A.D 22”x22”
05 BUFFER 01 S.A.D 12”x12”
06 BUFFER 02 S.A.D 12”x12”
07 CHANGE ROOM S.A.D 12”x12”
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Sr. OUTLET
No. AREA NAME
TYPE SIZE
01. INFUSION VIAL FILLING ROOM RAG 14”x12”

02. INFUSION VIAL FILLING ROOM RAG 14”x12”

03. BUFFER 01 RAG 12”x12”

04. BUFFER 02 RAG 12”x12”

05. CHANGE ROOM RAG 12”x12”

4.4 AHU No.18

AHU No.18 has been design and installed for terminal application and attached as annexure # 4.
There are 04 HEPA filters, which contain 99.997 % efficient (0.3 micron) HEPA filter. AHU No.
18 serves the following location of Injection Filling Room as shown in figure no. 1. There is
about 04 supply air diffuser (SAD) and 02 return air grill (RAG).
[Link]. OUTLET
AREA NAME
TYPE SIZE
01. INJECTION FILLING ROOM S.A.D 12”x12”
02. INJECTION FILLING ROOM S.A.D 12”x12”

03. INJECTION FILLING ROOM S.A.D 12”x12”

04. INJECTION FILLING ROOM S.A.D 12”x12”

Sr. No. OUTLET

AREA NAME
TYPE SIZE
01. INJECTION FILLING ROOM RAG 12”x12”
02. INJECTION FILLING ROOM RAG 12”x12”
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4.5 AHU No.19

AHU No.19 design and installed for terminal application and attached as annaxure # 5.
There are 02 HEPA filters, which contain 99.997 % efficient (0.3 micron) HEPA filter. AHU No.
19 serves the following location of Ampoule Section as shown in figure no. 1. There is about 02
supply air diffuser (SAD) and 02 return air grill (RAG).

[Link]. OUTLET
AREA NAME
TYPE SIZE
01. AMPOULE FILLING ROOM S.A.D 22”x22”
02. AMPOULE FILLING ROOM S.A.D 22”x22”

Sr. No. OUTLET

AREA NAME
TYPE SIZE
01. AMPOULE FILLING ROOM RAG 14”x12”
02. AMPOULE FILLING ROOM RAG 14”x12”

4.6 AHU No.20

AHU No.20 designd and installed for terminal application and attached as annexure # 6.
There is 01 supply air diffuser. AHU No. 20 serves the following location of Ampoule Section as
shown in figure no. 1. There is about 01 supply air diffuser (SAD) and 01 return air grill (RAG).
[Link]. OUTLET
AREA NAME
TYPE SIZE
01. AMPOULE WASHING S.A.D 12”x10”

Sr. No. OUTLET

AREA NAME
TYPE SIZE
01. AMPOULE WASHING RAG 14”x12”
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4.7 Air Flow and Uniformity Test

Air Balancing:

Air balancing activity consists on the following steps.

4.7.1 Measurement of air volumes in supply and return air diffuser or terminal HEPA filter.
4.7.2 Measurement of differential pressure between the adjutant room
4.7.3 Measurement of air velocity of terminal HEPA filter
4.7.4 Air change per hour

4.7.1 Measurement of Air volume in supply and return air diffuser or terminal HEPA filter

 Air volume of supply and return air diffuser attached as relevant annexure
 Location of the SAD/RAG is given in figure no.1.
 Equipment used :

[Link]. Equipment Model No. Range Resolution

1 Balometer DPI 610. Multiple ± 0.01

2 Digital Tachometer DT-2268A Multiple ±2 rpm

 Calibration Review

Equipment Calibrating Agency Calibration Date of Calibration

(Name & Address) Certificate Calibration due Date
Number
Balometer Delta Control 16/07/0562634 07/11/2018 08/11/2018
Engineering Co.
Digital Tachometer Delta Control 16/07/0562637 07/11/2018 08/11/2018
Engineering Co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

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 Acceptance criteria:

 Allowable Tolerance for Airflow rate is ± 10% of designed volume.

 Reading will take at 40 in. above the floor in the center of the grid for minimum 15 seconds. (If
40 inch space is not available then the reading will take at height of the false ceiling and length
of diffuser hood)
 No object within 10 ft of the anemometer, except fixed equipment.
4.7.2 Measurement of differential pressure between the adjutant rooms

 Differential pressure between the adjutant rooms attached as relevant annexures.

 Location of the SAD/RAG is given in figure no.1.

Equipment:

[Link]. Equipment/ Instruments Model No. Range Resolution

1 Micro Environmental WH-1 0~125 Pascal 0.2%
Detector

 Calibration Review

Equipment/ Instruments Calibrating Agency Calibration Date of Calibration

(Name & Address) Certificate Calibration due Date
Number
Micro Environmental Delta Control 16/07/0562638 08/11/2018 07/11/2018
Detector Engineering Co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

4.7.3 Measurement of Air Velocity of HEPA filters

 Velocity of supply air was attached as relevant annexure .
 Location of the SAD/RAG is given in figure no. 1.
Equipment:

S. No. Equipment/ Model No. Range Resolution

Instruments
1 Velometer VEL-7060 Multiple ±0.01
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 Calibration Review
Equipment/ Calibrating Agency Calibration Date of Calibration
Instruments (Name & Address) Certificate Calibration due Date
Number
Velometer Delta Control 16/07/0562635 07/11/2018 08/11/2018
Engineering Co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

Acceptance Criteria:

 0.45 m/s (90 fpm) ± 20%

 Reading will take at 6 inch away from face of HEPA filter.
 The HEPA filter will be changed or adjusted if the velocity fails out range 72- 108 fpm.
4.7.4 Measurement of Air Changes Per Hour

 Room Air changes per hour for the 100,000 or ISO 8 was taken per ISO Test Method ISO
No.14644-8 and attached as relevant annexures their results are also attached as relevant
annexures.
 The reading was taken of the different locations mentioned in figure #1.
 Total supply air to the room was first calculated.
 Length, width and height of rooms are to be measured and volume is calculated by
multiplying all.
 The air changes was calculated as below:

Calculation:

Volume of Room  Length  Breadth  Height of the Room

Total Actual Supply Air CFM  60 min .

Air Changes per hour 
Room Volume (cu. ft)

 Equipment:

S. No. Equipment/ Instruments Model No. Range Resolution

1 Balometer DPI 610 Multiple ± 0.01
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 Calibration Review

Equipment/ Calibrating Agency Calibration Date of Calibration

(Name & Address) Certificate Calibration due Date
Number

Balometer Delta control 16/07/0562634 08/11/2018 07/11/2018

engineering co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

5.0 HEPA FILTER LEAKAGE TEST

 Injectable Area, Vial Section, Ampoule Section & QC Lab contains 17 HEPA Filters which
installed and design for unidirectional flow.
 The leakage conducted test at operational condition.
 The result of all the HEPA filter attached their relevant annexure.

 Equipment

S. Equipment/ Instruments Model No. Range Resolution

No.
1 Aerosol Photometer TDA-2EL Multiple 0.001%
2 Aerosol TDA-5A -- ---

 Calibration Review

Process Calibrating Date of Calibration Calibration

Instrumentation Agency (Name & Calibration due date Certificate No
Address)
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Aerosol Photometer National 08/11/2017 07/11/2018 Tech-2017-18

[Link],picocamp Institute of
Source Standards and
[Link] DMM Technology
3 Flow meter

Reviewed & Inspected by:

Name: _____________ Signature: _____________ Date: _____________

Acceptance Criteria
 Acceptable filter leak range less than 0.01%
 0.01% leakage to be repair
 Leak are sealed using silicone sealant by caulking 1.5 inches (dimension) around the leak parallel
to the medium and between the separators and smoothed flush with the separators. The filter is
then rechecked for leaks as specified above.

The extent of filter face obscured at any point by patching material is limited to 5% of the filter area
so that the resulting void in the air stream will be filled in before reaching the work area. If more is
sealed, the filter must be rejected and a new one installed.
6.0 TEMPRATURE AND HUMIDITY CONTROL TEST

 Temperature and relative humidity was carried out that attached as relevant annexures. Their
results are also attached as for at operational condition.
 Blower was run in continuous operation for at least 24 hr prior to taking the temperatures/
relative humidity reading. All the light in the Injectable Area was “ON” during the temp.
1. Temperature/ relative humidity were taken at operational condition and during packing of
actual product.
2. Measure and record temperature at 3 hr interval for one day (morning, noon and
evening).
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Apparatus:

Equipment/ Instruments Model No. Range Resolution

Micro Environmental WH-1 50C-400C ± 0.1%
Detector 10%--90% RH

 Calibration Review

Equipment/ Calibrating Agency Calibration Date of Calibration

Instruments (Name & Address) Certificate Calibration due Date
Number

Micro Delta Control 17/12/0133412 08/11/2017 07/11/2018

Environmental Engineering Co.
Detector

Reviewed & Inspected by:

Name: ______________________Signature:_______________ Date:_____________