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 (store rooms).
5.1.1. Packaging material store
5.1.2. quarantine
5.1.3. sampling
5.1.4. raw material store
5.2. Design qualification data (packaging).
5.2.1. In process quarantine.
5.2.2. Packaging area.
5.2.3. Pharmacist office.
5.2.4. Sachet filling.
5.2.5. QC corridor.
5.3. Design qualification data (dispensing)
5.3.1. Pre dispensing
5.3.2. Dispensing
5.3.3. Post dispensing
 5.4. Design qualification data (dry suspension and capsule
area)
5.4.1. Blistering
5.4.2. Capsule filling and polishing
5.4.3. Mixing
5.4.4. Dry suspension filling
5.4.5. Bottle blowing
5.4.6. De cartoning
5.4.7. corridor
5.5. Design qualification data (main corridor)
5.5.1. corridor
6. IQ (Installation Qualification).
6.1. Installation qualification data (store rooms).
6.1.1. Packaging material store
6.1.2. quarantine
6.1.3. sampling
6.1.4. raw material store
6.2. Installation qualification data (packaging).
6.2.1. In process quarantine.
6.2.2. Packaging area.
6.2.3. Pharmacist office.
6.2.4. Sachet filling.
6.2.5. QC corridor.
6.3. Installation qualification data (dispensing)
6.3.1. Pre dispensing
6.3.2. Dispensing
6.3.3. Post dispensing
6.4. Installation qualification data (dry suspension and capsule
area)
 6.4.1. Blistering
6.4.2. Capsule filling and polishing
6.4.3. Mixing
6.4.4. Dry suspension filling
6.4.5. Bottle blowing
6.4.6. De cartoning
6.4.7. corridor
6.5. Installation qualification data (main corridor)
6.5.1. 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:

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

PACKAGING MATERIAL STORE

QUARANTINE
SAMPLING
RAW MATERIAL STORE

Packaging Area for M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD.

LAHORE. Consists of the following rooms as under

IN PROCESS QUARANTINE
PACKAGING AREA
PHARMACIST OFFICE
SACHET FILLING
QC CORRIDOR

Dispensing Area for M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD.

LAHORE. Consists of the following rooms as under

PRE DISPENSING
DISPENSING
POST DISPENSING

Dry suspension and capsule Area for M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD.
LAHORE. Consists of the following rooms as under

BLISTERING
CAPSULE FILLING AND
POLISHING
MIXING
DRY SUSPENSION FILLING
BOTTLE BLOWING
DE CARTONING
CORRIDOR

Main corridor Area for M/S HI-MEDIC PHARMACEUTICAL (PVT) LTD.

LAHORE. Consists of the following rooms as under
 CORRIDOR

4. Brief introduction to HVAC systems:

The Heating, Ventilation, Air Conditioning system of Storage 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 # CFM 2235
ESP 302” WG
Cooling Capacity 7.5 TR
Cooling Coil Type DX – Type

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

AHU NO 02
DESIGNED CFM 2650
AHU # CFM 2650
ESP 2.4” WG
Cooling Capacity 9.0 TR
Cooling Coil Type DX – type
The Heating, Ventilation, Air Conditioning system of Dispensing 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 # CFM 2235
ESP 302” WG
Cooling Capacity 7.5 TR
Cooling Coil Type DX – Type
The Heating, Ventilation, Air Conditioning system of Dry suspension and capsule 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 # CFM 2235
ESP 302” WG
Cooling Capacity 7.5 TR
Cooling Coil Type DX – Type
The Heating, Ventilation, Air Conditioning system of Main corridor 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 # CFM 2235
ESP 302” WG
Cooling Capacity 7.5 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-05: Storage rooms
No. Parameter/ function Function / operation, Rated value (incl.
relevant for quality material specification Tolerances)
1. Supply Air CFM Direction effect on room 2235 ± 10 %
temperature
2. Room Temperature Direct effect on room 72 ± 2 FDB
temperature & product
3. Filtration level Director effect on room Air
Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4. Room R.H (%) Director effect on Room & 35 ± 5 % RH
Product Air Quality
AHU-04: Packaging
No. Parameter/ function Function / operation, Rated value (incl.
relevant for quality material specification Tolerances)
1. Supply Air CFM Direction effect on room 2235 ± 10 %
temperature
2. Room Temperature Direct effect on room 72 ± 2 FDB
temperature & product
3. Filtration level Director effect on room Air
Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4. Room R.H (%) Director effect on Room & 35 ± 5 % RH
Product Air Quality

AHU-07: Dispensing
No. Parameter/ function Function / operation, Rated value (incl.
relevant for quality material specification Tolerances)
1. Supply Air CFM Direction effect on room 2235 ± 10 %
temperature
2. Room Temperature Direct effect on room 72 ± 2 FDB
temperature & product
3. Filtration level Director effect on room Air
Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4. Room R.H (%) Director effect on Room & 35 ± 5 % RH
Product Air Quality

AHU-03: Dry suspension and capsule area

No. Parameter/ function Function / operation, Rated value (incl.
relevant for quality material specification Tolerances)
1. Supply Air CFM Direction effect on room 2235 ± 10 %
temperature
2. Room Temperature Direct effect on room 72 ± 2 FDB
temperature & product
3. Filtration level Director effect on room Air
Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4. Room R.H (%) Director effect on Room & 35 ± 5 % RH
Product Air Quality
AHU-06: Main corridor

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

relevant for quality specification Tolerances)
1 Supply Air CFM Direction effect on room 2650 ± 10%
temperature
2 Room temperature Direct effect on room 73 ± 2 FDB
temperature & product
3 Filtration Level Director effect on room Air Pre Filter: G4
Quality Fine Filter: F6
Fine Filter: F9
Hepa Filter: H13
4 Room R.H (%) Director effect on Room & 50 ± 5 % RH
product Air quality

4.2. The Critical Parameters:

HVAC Systems are installed to control the internal environment of the mentioned areas 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 areas,
HVAC system controls the following parameters within all 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.
The 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
ALUM SEALS ENTRY 15 / Hr
GOWNING / DE GOWNING 20 / Hr
BUFFER 15 / Hr

The control the range of temperature and humidity within the area 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 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.
 4.7. Area Pressure Cascade:
Pressure cascade is another measure that prevents the product and environment form
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, 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 (Store rooms)

5.1.1. Packaging material store

Serial Parameter Designed

#
PACKAGING MATERIAL STORE
1 Room Size 21’ -03’’ X 13’ – 0’’
2 Room Area 276.25 Square Feet
3 Room Height 10’ - 0
4 Room Volume 2762.5 Cubic Feet
 5 No of Supply air Devices 03 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 467
7 Total Supply air Volume CFM 935
8 Air Change Rate / Hr 40
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 40 PA
12 Final Filtration HEPA
13 No of return air devices 02 NO
14 Flow Rate at RA Terminals
RAR 01 CFM 795
15 Total Return air Volume CFM 795
16 Area Grade B
5.1.2. Quarantine

Serial Parameter Designed

#
QUARANTINE
1 Room Size 12’ -0’’ X 7’ – 0’’
2 Room Area 84 Square Feet
3 Room Height 10’ – 0
4 Room Volume 840 Cubic Feet
5 No of Supply air Devices 01 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 225
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 190
15 Total Return air Volume CFM 190
16 Area Grade C

5.1.3. Sampling

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 8’ - 0’’ X 7’ – 0’’
2 Room Area 56 Square Feet
3 Room Height 10’
4 Room Volume 560 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 450
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 380
15 Total Return air Volume CFM 380
16 Area Grade B

5.1.4. Raw material store

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 31’ - 03’’ X 13’ – 2’’
2 Room Area 411 Square Feet
3 Room Height 10’
4 Room Volume 4110 Cubic Feet
5 No of Supply air Devices 02 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 20
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 25 PA
12 Final Filtration S.A.D
13 No of return air devices 02 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
 16 Area Grade D

5.2. Design Qualification Data (packaging)

5.2.1 in process quarantine
Serial# Parameter Designed
In process quarantine
1 Room Size 19’ -3’’ X 15’ – 1’’
2 Room Area 290.3 Square Feet
3 Room Height 10’ - 0
4 Room Volume 2903 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 520
7 Total Supply air Volume CFM 1035
8 Air Change Rate / Hr 25
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 50 ± 5 %
11 Room Pressurization 25 PA
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAR 01 CFM 440
15 Total Return air Volume CFM 875
16 Area Grade D

5.2.2 Packaging area

Serial# Parameter Designed
Packaging area
1 Room Size 19’ - 3’’ X 33’ – 8’’
2 Room Area 648 Square Feet
3 Room Height 10’ – 0
4 Room Volume 6480 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 125
7 Total Supply air Volume CFM 125
8 Air Change Rate / Hr 20
 9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 50 ± 5 %
11 Room Pressurization 15 PA
12 Final Filtration S.A.D
13 No of return air devices 02 No
14 Flow Rate at RA Terminals
RAD 01 CFM 105
15 Total Return air Volume CFM 105
16 Area Grade D

5.2.3 pharmacist office

Serial# Parameter Designed
Pharmacist office
1 Room Size 10’ - 10’’ X 9’ – 2’’
2 Room Area 99 Square Feet
3 Room Height 10’
4 Room Volume 990 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 50 ± 5 %
11 Room Pressurization 15 PA
12 Final Filtration S.A.D
13 No of return air devices 01 No
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D

5.2.4 sachet filling

Serial# Parameter Designed
Sachet filling
1 Room Size 10’ - 10’’ X 10’ – 0’’
2 Room Area 108 Square Feet
3 Room Height 10’
4 Room Volume 1080 Cubic Feet
5 No of Supply air Devices 01 No
 6 Flow Rate at SA Terminals
SAD- 01 CFM 130
7 Total Supply air Volume CFM 130
8 Air Change Rate / Hr 15
9 Average Room Temperature < 73 ± 2 FDB
10 Average Room Relative Humidity < 50 ± 5 %
11 Room Pressurization 20 PA
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 110
15 Total Return air Volume CFM 110
16 Area Grade D

5.2.5 qc corridor
Serial# Parameter Designed
Qc corridor
1 Room Size 5’ - 0’’ X 76’ – 0’’
2 Room Area 380 Square Feet
3 Room Height 10’
4 Room Volume 3800 Cubic Feet
5 No of Supply air Devices 03 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
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 < 50 ± 5 %
11 Room Pressurization 30 PA
12 Final Filtration HEPA
13 No of return air devices 03 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D
 5.3. Design Qualification Data (dispensing)
5.3.1. Pre dispensing

Serial Parameter Designed

#
VIAL FILLING
1 Room Size 7’ -7’’ X 6’ – 0’’
2 Room Area 45.6 Square Feet
3 Room Height 10’ - 0
4 Room Volume 456 Cubic Feet
5 No of Supply air Devices 01 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 467
7 Total Supply air Volume CFM 935
8 Air Change Rate / Hr 40
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 40 PA
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAR 01 CFM 795
15 Total Return air Volume CFM 795
16 Area Grade B
5.3.2. Dispensing

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 6’ -0’’ X 6’ – 0’’
2 Room Area 12 Square Feet
3 Room Height 10’ – 0
4 Room Volume 120 Cubic Feet
5 No of Supply air Devices 01 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 225
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
 9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 190
15 Total Return air Volume CFM 190
16 Area Grade C

5.3.3. post dispensing

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 6’ - 7’’ X 8’ – 0’’
2 Room Area 58.8 Square Feet
3 Room Height 10’
4 Room Volume 588 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 450
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 380
15 Total Return air Volume CFM 380
16 Area Grade B

5.4. Design Qualification Data (dry suspension and capsule

area)
5.4.1. Blistering
Serial Parameter Designed
#
VIAL FILLING
1 Room Size 10’ -4’’ X 19’ – 6’’
2 Room Area 201 Square Feet
3 Room Height 10’ - 0
4 Room Volume 2010 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 467
7 Total Supply air Volume CFM 935
8 Air Change Rate / Hr 40
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 40 PA
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAR 01 CFM 795
15 Total Return air Volume CFM 795
16 Area Grade B
5.4.2. Capsule filling and polishing

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 10’ -0’’ X 13’ – 5’’
2 Room Area 134 Square Feet
3 Room Height 10’ – 0
4 Room Volume 1340 Cubic Feet
5 No of Supply air Devices 01 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 225
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 190
 15 Total Return air Volume CFM 190
16 Area Grade C

5.4.3. mixing

Serial Parameter Designed

#
VIAL COOLING
1 Room Size 12’ - 0’’ X 13’ – 5’’
2 Room Area 161 Square Feet
3 Room Height 10’
4 Room Volume 1610 Cubic Feet
5 No of Supply air Devices 02 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 450
7 Total Supply air Volume CFM 450
8 Air Change Rate / Hr 35
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 53 PA
12 Final Filtration HEPA
13 No of return air devices 01 Nos
14 Flow Rate at RA Terminals
RAD 01 CFM 380
15 Total Return air Volume CFM 380
16 Area Grade B

5.4.4. dry suspension filling

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 15’ - 7’’ X 13’ – 5’’
2 Room Area 209 Square Feet
3 Room Height 10’
4 Room Volume 2090 Cubic Feet
5 No of Supply air Devices 02 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 20
 9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 25 PA
12 Final Filtration S.A.D
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D

5.4.5 bottle blowing

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 11’ - 9’’ X 9’ – 5’’
2 Room Area 110.45 Square Feet
3 Room Height 10’
4 Room Volume 1104.5 Cubic Feet
5 No of Supply air Devices 01 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 15
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 15 PA
12 Final Filtration S.A.D
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D

5.4.6 decartoning

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 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 20
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 20 PA
12 Final Filtration S.A.D
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D

5.4.7 corridor

Serial Parameter Designed

#
AIR SHOWER
1 Room Size 37’ - 7’’ X 6’ – 0’’
2 Room Area 225.6 Square Feet
3 Room Height 10’
4 Room Volume 2256 Cubic Feet
5 No of Supply air Devices 02 No
6 Flow Rate at SA Terminals
SAD- 01 CFM 100
7 Total Supply air Volume CFM 100
8 Air Change Rate / Hr 15
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 10 PA
12 Final Filtration S.A.D
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAD 01 CFM 80
15 Total Return air Volume CFM 80
16 Area Grade D
 5.5. Design Qualification Data (main corridor)
5.5.1. corridor

Serial Parameter Designed

#
VIAL FILLING
1 Room Size 15’ -10’’ X 15’ – 9’’
2 Room Area 250 Square Feet
3 Room Height 10’ - 0
4 Room Volume 2500 Cubic Feet
5 No of Supply air Devices 02 Nos
6 Flow Rate at SA Terminals
SAD- 01 CFM 467
7 Total Supply air Volume CFM 935
8 Air Change Rate / Hr 40
9 Average Room Temperature < 72 ± 2 FDB
10 Average Room Relative Humidity < 35 ± 5 %
11 Room Pressurization 40 PA
12 Final Filtration HEPA
13 No of return air devices 01 NO
14 Flow Rate at RA Terminals
RAR 01 CFM 795
15 Total Return air Volume CFM 795
16 Area Grade B

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 (storage):
6.1.1. packaging material store:
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. quarantine:
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. sampling:
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. raw material store:

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
6.2. Installation qualification data (packaging):
6.2.1. in process quarantine:
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. packaging 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. pharmacist office:

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. sachet filling:

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. qc corridor:
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) - -

6.3. Installation qualification data (dispensing):

6.3.1. pre dispensing:
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

6.3.2. dispensing:
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

6.3.3. post dispensing:

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

6.4. Installation qualification data (dry suspension and capsule

area):
6.4.1. blistering:
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

6.4.2. capsule filling and polishing:

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

6.4.3. mixing:
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

6.4.4. dry suspension filling:

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
 6.4.5. bottle blowing:
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) - -

6.4.3. de cartoning:
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

6.4.4. corridor:
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

6.5. Installation qualification data (main corridor):

 6.5.1. corridor:
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

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.