QUALIFICATION & VALIDATION

OF

HEATING, VENTILATING AND AIR

CONDITIONING (HVAC) SYSTEM

HIMEDIC PHARMACEUTICAL
(PVT) LTD. LAHORE

PREPARED BY: MUHAMMAD UMAIR KHAN

CEPAS (Creative Engineering Products and Services)

19-KM Link Mu1tan Road, Lahore - Pakistan

Tel: +92-42-35971456

[email protected]

REPORT SUBMITTED TO,

HI-MEDIC PHARMACEUTICAL (PVT) LTD.

19-KM MULTAN ROAD, LAHORE

Table of contents:
1. Introduction.
2. Overview of qualification and validation.
3. Description of area layouts.
4. Brief introduction to HVAC systems.
4.1. Quality relevant parameters and functions.
4.2. The critical parameters.
4.3. Temperature.
4.4. Humidity.
4.5. Air change rates.
4.6. Air cleanliness classes.
4.7. Air pressure cascade.
4.8. Fresh air makeups.
5. Design criteria; DQ (Design Qualification).
5.1. Design qualification data (vial filling).
5.1.1. Vial filling.
5.1.2. Vial cooling.
5.1.3. Vial sealing.
5.1.4. Air shower.
5.1.5. Aluminium seals entry.
5.1.6. Gowning/DE gowning.
5.1.7. Buffer.
5.2. Design qualification data (vial washing).
5.2.1. Vial washing.
5.2.2. Gowning/ de gowning.
5.2.3. Air lock 4.
5.2.4. Vial de-cartoning.
5.2.5. Air shower.
5.2.6. Buffer.
5.2.7. Material receiving.
5.2.8. Gowning.
5.2.9. De gowning.
 5.2.10. Material entry.
5.2.11. Air lock 1.
5.2.12. Air lock 2.
5.2.13. Air lock 3.
5.2.14. Corridor.
6. IQ (Installation Qualification).
6.1. Installation Qualification Data (Vial filling).
6.1.1. Vial filling.
6.1.2. Vial cooling.
6.1.3. Vial sealing.
6.1.4. Air shower.
6.1.5. Aluminium seals entry.
6.1.6. Gowning/ DE gowning.
6.1.7. Buffer.
6.2. Installation qualification data (vial washing).
6.2.1. Vial washing.
6.2.2. Gowning/DE gowning.
6.2.3. Air lock 4.
6.2.4. Vial De cartoning.
6.2.5. Air shower.
6.2.6. Buffer.
6.2.7. Material receiving.
6.2.8. Gowning.
6.2.9. De gowning.
6.2.10. Material entry.
6.2.11. Air lock 1.
6.2.12. Air lock 2.
6.2.13. Air lock 3.
6.2.14. Corridor.
7. References.
 1. Introduction:
This guidance documents describes the current basic concepts on sterility assurance and
associated procedures for manufacturing and controlling sterile pharmaceutical products. To
advise manufacturers of sterile pharmaceutical inspections on sterility assurance of the
products processed by terminal sterilization procedures.

In principle, the requirements specified in this guidance documents are applicable to

parenteral drugs; however, there are a number of requirements that may be commonly applied
to other forms of sterile dosage forms. The concepts and descriptions contained in this
guidance may be superseded by other processes or procedures of manufacture that are
justifiably comparable or more stringent (except for the Ministerial Ordinance No. 179, 2004)
and other regulatory requirements, notifications, and issues) as long as the quality of
pharmaceutical products can be ensured.

2. Overview of qualification and validation:

Qualification and validation follow similar underlying principles. The term “qualification” is
normally used, for example, for equipment and utilities, and “validation”, for example, for
systems, methods and processes.

Qualification and validation are essential components of the same concept. Qualification
normally precedes validation.

Approach used during the documentation is referred as prospective and concurrent validation.
Major equipment, critical utilities and systems require DQ (design qualification), IQ
(Installation qualification), OQ (Operational qualification) and PQ (performance
qualification).

3. Description of area layouts:

Vail Filling Area for M/S HI-MEDIC PHARMACEUITICAL (PVT) LTD.LAHORE.
Consists of the following rooms as under

VIAL FILLING
VIAL COOLING
VIAL SEALING
AIR SHOWER
ALUMINIUM SEALS
ENTRY
GOWNING/DEGOWNING
BUFFER
Vail washing Area for M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD.LAHORE.
Consists of the following rooms as under

VIAL WASHING
 GOWNING / DEGOWNING
AIR LOCK-4
VIAL DECARTONING
AIR SHOWER
BUFFER
MATERIAL RECEIVING
GOWNING
DE GOWNING
MATERIAL ENTRY
AIR LOCK-1
AIR LOCK-2
AIR LOCK-3
CORRIDOR

4. Brief introduction to HVAC systems:

The Heating, Ventilation, Air Conditioning system of. Vial Filling & Vial Cooling Area of
M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD. Is designed as single zone.

Air Handling units specifications are as under,

AHU NO 01
DESIGNED CFM 2235
AHU #01 CFM 2235
ESP 302” WG
Cooling Capacity 7.5 TR
Cooling Coil Type DX – Type

The Heating, Ventilation, Air Conditioning system of. Vial Washing & Vial De Cartoning
Area of M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD. is designed as single zone.

AHU NO 02
DESIGNED CFM 2650
AHU #02 CFM 2650
ESP 2.4” WG
Cooling Capacity 9.0 TR
Cooling Coil Type DX – type

4.1. Quality relevant parameter and functions:

Following parameters and functions are checked, which are relevant for quality.
AHU-01: Vial Filling & Vial Cooling
 No. Parameter/ function Function / operation, Rated value (incl.
relevant for quality material specification Tolerances)
1. Supply Air CFM Direct effect on room 2235 ± 10 %
temperature
2. Room Temperature Direct effect on room 72 ± 2 FDB
temperature & product
3. Filtration level Direct effect on room Air
Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4. Room R.H (%) Direct effect on Room & 35 ± 5 % RH
Product Air Quality

AHU-02: Vial Washing & Vial De Cartoning Area

No. Parameter / function Function / Operation, material RATED VALUE (incl.

relevant for quality specification Tolerances)
1 Supply Air CFM Direct effect on room 2650 ± 10%
temperature
2 Room temperature Direct effect on room 73 ± 2 FDB
temperature & product
3 Filtration Level Direct effect on room Air Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4 Room R.H (%) Direct effect on Room & 35 ± 5 % RH
product Air quality

4.2. The Critical Parameters:

HVAC Systems are installed to control the internal environment of the Vial Filling & Vial
Cooling etc. to improve the product quality and to prevent the product from contamination
and cross contamination and to reduce the health risk of operators HVAC system controls the
following parameters within the Vial Filling & Vial Cooling Areas etc.
HVAC system controls the following parameters within the areas,
Temperature
Humidity
Air Change Rates
Air Cleanliness Classes
Area Pressure Cascade
Fresh Air Make Ups

4.3. Temperature:
The temperature range of the product and process at which the product is handled and for the
comfort of people working in the area, the design temperature range of the areas is in a range
of ≤ 72 ± 2 Degrees FDB.
 4.4. Humidity:
Humidity is as critical parameter for the quality of product as temperature. It also has critical
impact on the operators comfort.
The humidity range controlled within the areas is ≤ 35 ± 5 %

4.5. Air Change Rates:

Air Change Rate is the proportionate of the conditioned supply air volume and the volume of
the area.
To control the range of temperature and humidity within the area the air change rate is
designed as follows.

VIAL FILLING 40 / Hr
VIAL COOLING 35 / Hr
VIAL SEALING 30 / Hr
AIR SHOWER 20 / Hr
ALUMINIUM SEALS ENTRY 15 / Hr
GOWNING / DE GOWNING 20 / Hr
BUFFER 15 / Hr

The control the range of temperature and humidity within the vial washing the air change rate
is designed as follows.

VIAL WASHING 25 / Hr
GOWNING / DE GOWNING 20 / Hr
AIR LOCK - 4 15 / Hr
VIAL DE CARTONING 15 / Hr
AIR SHOWER 20 / Hr
BUFFER 20 / Hr
MATERIAL RECEIVING 20 / H r
GOWNING 20 / H r
DE GOWNING 20 / H r
MATERIAL ENTRY 20 / H r
AIR LOCK -1 20 / H r
AIR LOCK -2 15 / H r
AIR LOCK -3 15 / H r
CORRIDOR 15 / H r

4.6. Air Cleanliness Classes:

The most critical parameter which confirms the purity of the product along with operator’s
safety and health is air cleanliness class within the area.
The Areas in Vial Filling & Vial Cooling etc. Areas are equipped with filtration system up to
99.99 % (H-13) efficiency H-13 Grade Filters are used as final filters at terminal to protect
the product from contamination and cross contamination.
The Vial Filling & Vial Cooling Area, etc. is tested while ‘at rest’ condition for the
qualification of the process area in Class, B/C/D.

4.7. Area Pressure Cascade:

Pressure cascade is another measure that prevents the product and environment form
contamination and cross contamination.

Vial Filling & Vial Cooling are maintained at highest positive pressure and Buffers are
maintained at relatively lower pressure to prevent contamination and cross contamination.

The designed pressure Cascade Range is 15 ᷉ 40 ± 2 Pascal (3.2” W.C)

4.8. Fresh Air Make Ups:

All the Air Handling Units have 10 ᷉ 15 % of Fresh air intake to establish a good oxygen
level for the health and safety of the operators.

5. Design Criteria; DQ (Design Qualification):

The HVAC system of the M/S system of the M/S HI-MEDIC PHARMACEUTICAL (PVT)
LTD, Vial Filling & Vial Cooling Area etc. section is designed at the following parameters.

Temperature < 72 ± 2 FDB

Humidity ≤ 35 ± 5 %

Filtration Sequence, according to EN 13779:

i. Washable Filter 45% Eff. In RA Grill

ii. Pre Filter 55% Eff. In AHU
iii. Bag Filters 65 % Eff. In AHU
iv. Mini Pleat Filters 95 % Eff. In AHU
v. Hepa Filters 99.99% Eff In Area

5.1. Design Qualification Data (Vial filling):

5.1.1. Vial Filling:

Serial Parameter Designed

#
VIAL FILLING
1 Room Size 15’ -9’’ X 15’ – 9’’
2 Room Area 248 Square Feet
3 Room Height 10’ - 0
 4 Room Volume 2480 Cubic Feet
5 No of Supply air Devices 03 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM(01/08S)
SAD- 02 CFM(01/07S)
SAD- 03 CFM(01/04S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 40
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 02 NO
14 Flow Rate at RA Terminals
RAD- 01 CFM(01/05R)
RAD- 02 CFM(01/03R)
15 Total Return air Volume CFM
16 Area Grade B

5.1.2. Vial Cooling:

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 14’ -3’’ X 8’ – 0’’
2 Room Area 114 Square Feet
3 Room Height 10’ – 0
4 Room Volume 1140 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM(01/05S)
SAD- 02 CFM(01/06S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 02 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM(01/01R)
RAD 02 CFM(01/02R)
15 Total Return air Volume CFM
16 Area Grade B
 5.1.3. Vial Sealing:

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 10’ - 0’’ X 10’ – 0’’
2 Room Area 100 Square Feet
3 Room Height 10’
4 Room Volume 1000 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/12S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 30
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD-01 CFM(02/13R)
15 Total Return air Volume CFM
16 Area Grade B

5.1.4. Air Shower:

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 5’ - 0’’ X 5’ – 0’’
2 Room Area 25 Square Feet
3 Room Height 10’
4 Room Volume 250 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(01/03S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration S.A.D
13 No of return air devices N/A
14 Flow Rate at RA Terminals
 15 Total Return air Volume CFM
16 Area Grade C

5.1.5 Aluminium seals entry:

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 4’ - 7’’ X 5’ – 0’’
2 Room Area 23 Square Feet
3 Room Height 10’
4 Room Volume 230 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration S.A.D
13 No of return air devices N/A
14 Flow Rate at RA Terminals
15 Total Return air Volume CFM
16 Area Grade C

5.1.6 Gowning/DE gowning:

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 5’ - 0’’ X 5’ – 0’’
2 Room Area 25 Square Feet
3 Room Height 10’
4 Room Volume 250 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(01/01S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration S.A.D
 13 No of return air devices N/A
14 Flow Rate at RA Terminals
15 Total Return air Volume CFM
16 Area Grade C

5.1.7 Buffer:

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 4’ - 7’’ X 5’ – 0’’
2 Room Area 23 Square Feet
3 Room Height 10’
4 Room Volume 230 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration N/A
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(01/04R)
15 Total Return air Volume CFM
16 Area Grade C

5.2. Design Qualification Data (Vial washing)

5.2.1 Vial Washing:
Serial# Parameter Designed
VIAL WASHING
1 Room Size 17’ -3’’ X 18’ – 6’’
2 Room Area 319.125 Square Feet
3 Room Height 10’ - 0
4 Room Volume 3191.25 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/06S)
SAD- 01 CFM(02/05S)
 7 Total Supply air Volume CFM
8 Air Change Rate / Hr 25
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 02 NO
14 Flow Rate at RA Terminals
RAD-01 CFM(02/06R)
RAD-02 CFM(02/01R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.2 Gowning / DE gowning:

Serial# Parameter Designed
GOWNING / DE GOWNING
1 Room Size 7’ - 0’’ X 6’ – 0’’
2 Room Area 42 Square Feet
3 Room Height 10’ – 0
4 Room Volume 420 Cubic Feet
5 No of Supply air Devices 01 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/01S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration S.A.D
13 No of return air devices N/A
14 Flow Rate at RA Terminals
15 Total Return air Volume CFM
16 Area Grade C

5.2.3 AIR LOCK-4:

Serial# Parameter Designed
AIR LOCK – 4
1 Room Size 7’ - 0’’ X 5’ – 9’’
2 Room Area 40.25 Square Feet
3 Room Height 10’
4 Room Volume 402.5 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
 9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration
13 No of return air devices 01 No
14 Flow Rate at RA Terminals
RAD 01 CFM(02/02R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.4 VIAL DE CARTONING:

Serial# Parameter Designed
VIAL DE CARTONING
1 Room Size 10’ - 0’’ X 5’ – 9’’
2 Room Area 57.5 Square Feet
3 Room Height 10’
4 Room Volume 575 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/04S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/04R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.5 AIR SHOWER:

Serial# Parameter Designed
AIR SHOWER
1 Room Size 5’ - 0’’ X 5’ – 5’’
2 Room Area 27 Square Feet
3 Room Height 10’
4 Room Volume 270 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/08S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
 9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices N/A
14 Flow Rate at RA Terminals
15 Total Return air Volume CFM
16 Area Grade C

5.2.6 BUFFER:
Serial# Parameter Designed
BUFFER
1 Room Size 5’ - 0’’ X 5’ – 5’’
2 Room Area 27 Square Feet
3 Room Height 10’
4 Room Volume 270 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/10S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices N/A
14 Flow Rate at RA Terminals
15 Total Return air Volume CFM
16 Area Grade C

5.2.7 MATERIAL RECEIVING:

Serial# Parameter Designed
MATERIAL RECEIVING
1 Room Size 5’ - 5’’ X 5’ – 5’’
2 Room Area 29 Square Feet
3 Room Height 10’
4 Room Volume 290 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
 13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/12R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.8 GOWNING:
Serial# Parameter Designed
GOWNING
1 Room Size 5’ - 0’’ X 5’ – 9’’
2 Room Area 28.75 Square Feet
3 Room Height 10’
4 Room Volume 287.5 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/07S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/07R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.9 DE GOWNING:
Serial# Parameter Designed
DE GOWNING
1 Room Size 5’ - 0’’ X 5’ – 9’’
2 Room Area 28.75 Square Feet
3 Room Height 10’
4 Room Volume 287.5 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/09S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 50 ± 5 %
11 Room Pressurization
 12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/08R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.10 MATERIAL ENTRY:

Serial# Parameter Designed
MATERIAL ENTRY
1 Room Size 5’ - 5’’ X 5’ – 9’’
2 Room Area 31 Square Feet
3 Room Height 10’
4 Room Volume 310 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/11S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 20
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/09R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.11 AIR LOCK – 1:

Serial# Parameter Designed
AIR LOCK – 1
1 Room Size 5’ - 0’’ X 5’ – 9’’
2 Room Area 28.75 Square Feet
3 Room Height 10’
4 Room Volume 287.5 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
 9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/05R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.12 AIR LOCK -2:

Serial# Parameter Designed
AIR LOCK -2
1 Room Size 7’ - 0’’ X 5’ – 9’’
2 Room Area 40.25 Square Feet
3 Room Height 10’
4 Room Volume 402.5 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/10R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.12 AIR LOCK -3:

Serial# Parameter Designed
AIR LOCK -2
1 Room Size 5’ - 5’’ X 5’ – 9’’
2 Room Area 31 Square Feet
3 Room Height 10’
4 Room Volume 310 Cubic Feet
5 No of Supply air Devices N/A
6 Flow Rate at SA Terminals
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
 12 Final Filtration
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/11R)
15 Total Return air Volume CFM
16 Area Grade C

5.2.13 CORRIDOR:
Serial# Parameter Designed
CORRIDOR
1 Room Size 34’ - 4’’ X 5’ – 0’’
2 Room Area 171.5 Square Feet
3 Room Height 10’
4 Room Volume 1715 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM(02/03S)
SAD- 01 CFM(02/02S)
7 Total Supply air Volume CFM
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization
12 Final Filtration
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM(02/03R)
15 Total Return air Volume CFM
16 Area Grade D
 6. Installation Qualification Data (IQ):
To verify that the HVAC system is installed as per design and requirements of the GMP.
Validation committee is responsible for the Installation Qualification Activities of the HVAC
System of the Vail Filling, Sealing Section.
Parameters to be validated

 Installation of Ductwork / Leakage Testing / Insulation

 Installation of Air Handling Units
 Installation of Dehumidifier
 Installation of Volume Control Dampers Pre Filter / Bag & HEPA Filters (High
Efficiency Particulate Air Filters)
 Installation of return Air and Supply Air devices

6.1. Installation Qualification Data (Vial filling):

6.1.1. Vial Filling Area:
Sr. No. Parameter Designed Actual
Vial Filling
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
 7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals Hepa 18”x18”x12”=2
(Room)
10 Return air devices (Room) GI Powder Coated 22”x10”R.A.R=
01-Return on Wall 1 Nos

6.1.2. Vial Cooling Area:

Sr. No. Parameter Designed Actual
Vial Cooling
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals Hepa 15”x15”x12”= 2
(Room) Nos
10 Return air devices (Room) GI Powder Coated 10”x8”R.A.R= 2
01-Return on Wall Nos

6.1.3. Vial Sealing Area:

Sr. No. Parameter Designed Actual
Vial Sealing
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
 2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals Hepa 18”x18”x12”= 1
(Room) Nos
10 Return air devices (Room) GI Powder Coated 18”x6”R.A.R= 1
01-Return on Wall Nos

6.1.4. Air Shower Area:

Sr. No. Parameter Designed Actual
Air Shower
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals S.A.D 9”x9”= 1 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.1.5. Aluminium Seals Entry Area:

Sr. No. Parameter Designed Actual
Alum Seals Entry
1 HVAC Ductwork PU
 2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals S.A.D 9”x9”= 1 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.1.6. Gowning/De Gowning Area:

Sr. No. Parameter Designed Actual
Gowning/De Gowning
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals - -
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos
 6.1.7. Buffer Area:
Sr. No. Parameter Designed Actual
Buffer
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Insulation Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 7.5 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 6/8", 1/2"
Pipe Size
9 No. of Supply air terminals - -
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2. Installation qualification data (Vial washing):

6.2.1. Vial Washing Area:
Sr. No. Parameter Designed Actual
Vial Washing
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2235 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
 8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 24”x24”x6”=2
(Room) Nos
10 Return air devices (Room) GI Powder Coated 14”x10”R.A.R=
01-Return on Wall 1 Nos

6.2.2. Gowning/De Gowning Area:

Sr. No. Parameter Designed Actual
Gowning/De Gowning
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals S.A.D 9”x9”= 1 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.R= 1
01-Return on Sealing Nos

6.2.3. Air Lock-4 Area:

Sr. No. Parameter Designed Actual
Air Lock-4
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
 and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals S.A.D 9”x9”= 1 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.R= 1
01-Return on Sealing Nos

6.2.4. Vial De Cartoning Area:

Sr. No. Parameter Designed Actual
Vial De Cartoning
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals S.A.D 9”x9”= 1 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.R= 1
01-Return on Sealing Nos

6.2.5. Air Shower Area:

Sr. No. Parameter Designed Actual
Air Shower
1 HVAC Ductwork PU
2 Duct leakage test Physical
 3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 12”x12”= 1 Nos
(Room)
10 Return air devices (Room) - -

6.2.6. Buffer Area:

Sr. No. Parameter Designed Actual
Buffer
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 12”x12”x6”= 1
(Room) Nos
10 Return air devices (Room) - -

6.2.7. Material Receiving Area:

Sr. No. Parameter Designed Actual
Material Receiving
 1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 12”x12”x6= 1
(Room) Nos
10 Return air devices (Room) - -

6.2.8. Material Entry Area:

Sr. No. Parameter Designed Actual
Material Entry
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 12”x12”x6”= 1
(Room) Nos
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
 01-Return on Sealing Nos

6.2.9. De Gowning Area:

Sr. No. Parameter Designed Actual
De Gowning
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals Hepa 12”x12”x6”= 1
(Room) Nos
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2.10 Gowning Area:

Sr. No. Parameter Designed Actual
Gowning
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
 Pipe Size
9 No. of Supply air terminals Hepa 12”x12”x6”= 1
(Room) Nos
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2.11. Air Lock-1 Area:

Sr. No. Parameter Designed Actual
Air Loc-1
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals - -
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2.12. Air Lock-2 Area:

Sr. No. Parameter Designed Actual
Air Lock-2
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
 installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals - -
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2.13 Air Lock-3 Area:

Sr. No. Parameter Designed Actual
Air Lock-3
1 HVAC Ductwork PU
2 Duct leakage test Physical
3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals - -
(Room)
10 Return air devices (Room) GI Powder Coated 6”x6”R.A.D= 1
01-Return on Sealing Nos

6.2.14 Corridor Area:

Sr. No. Parameter Designed Actual
Corridor
1 HVAC Ductwork PU
2 Duct leakage test Physical
 3 Duct Joint Aluminium Type
4 Air Handling Unit Dx Type Unite
2650 CFM
With Pre Filter, F-6
and F-9 Filters
installation provision
5 Unit Capacity / Motor Capacity 9 TR
6 ELECTRIC REHEAT COIL -
7 Blower Motor DOL
8 Unit Connection Intel & Out let 1/2", 7/8"
Pipe Size
9 No. of Supply air terminals S.A.D 12”x12”= 2 Nos
(Room)
10 Return air devices (Room) GI Powder Coated 12”x12”R.A.D=
01-Return on Sealing 1 Nos

7. References:
1. Good manufacturing practices for sterile pharmaceutical products. In: WHO Expert
committee on specifications for Pharmaceutical Preparations. Thirty-sixth report.
Geneva, World Health organization, 2002 (WHO Technical Report Series, No. 902),
Annex 6; and in Quality assurance of pharmaceuticals. A compendium of guidelines
and related materials. Vol.2. 2nd updated ed. Good manufacturing practices and
inspection. Geneva, World Health Organization, 2007; and in Quality Assurance of
Pharmaceuticals. A compendium of guidelines and related materials. Geneva, World
Health Organization, 2010 (CD-ROM).
2. ISO 14644-1. Clean rooms and associated controlled environments. Part 1:
Classification of airborne particles. Geneva, International Organization for
Standardization.
3. ISO 14644-3. Clean rooms and associated controlled environments. Part 3: Test
methods. Geneva, International Organization for Standardization.
4. IDO 1822-4 High efficiency air filters (HEPA and ULPA). Determining leakage of
filter elements (scan method).
5. ISO 14644-4 clean rooms and associated controlled environments. Part4: Design,
construction and start-up. Geneva, international organization for Standardization.
6. ISO 14644-2. Clean rooms and associated controlled environments. Part 2:
Monitoring for continued compliance with ISO 14644-1. Geneva, International
Organization for Standardization.
7. ISO 14644-5 Clean rooms and associated controlled environments. Part5: Clean room
operations. Geneva, International Organization for Standardization.
8. Good manufacturing practices for pharmaceutical products: water for pharmaceutical
use. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Thirty-ninth report. Geneva, World Health Organization, 2005 (WHO Technical
Report Series, No. 929), Annex 3; and in Quality assurance of pharmaceuticals. A
compendium of guidelines and related materials. Vol.2. 2nd updated ed. Good
manufacturing practices and inspection. Geneva, World Health Organization, 2007.