Citi Pharma (Pvt.

) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

PROCESS VALIDATION REPORT

QUALITY ASSURANCE DEPARTMENT
PROCESS VALIDATION OF HVAC DOC NO./VERSION
QA/VA/PVR-001/01

Effective Date Review Date Superseded

January, 2015 January, 2020 Nil

ORIGINAL: Quality Assurance No. of Pages

COPIES TO: To HVAC 10

Reviewed By Approved by Authorized By

Exec. QA Officer Quality Assurance Manager Director Operations

Date: Date: Date:
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

ENVIRONMENT CONTROL PROCESSING WITH DETAILS

1. Every production section is provided with seperate AHU.
2. In each AHU three filters are installed:
i. Bag filter
ii. Pre filter
iii. HEPA filter at the terminal end of the duct inside the section
3. By the installation of these AHU we can control temperature and humidity inside the
production areas
4. Complete air handling system is PC controlled.

Design Criteria
The HVAC System of the CITI PHARMACEUTICALS is designed at the following
parameters.
Temperature 25ºC± 2ºC
Humidity 40± 5%
Air Changes 20 to 50 per hour
Filteration Sequences i. Pre filter 45% eff in RA grill
ii. Pre filter 55% eff in AHU
iii. Pocket Filters 95% eff in AHU
Iv. HEPA filter 99.5% eff in terminal filter boxes
Duet work material GI Sheet 22 SWG
Fresh air make up 10 to 15%
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

Air Handling Units specifications are as under:

IN PARACETAMOL PLANT
CENTRIFUGE AREA

Sr. No Parameter Designed

CENTRIFUGE AREA
1 Room Size 46’ x 22’
2 Room Area 1012 Square Feet
3 Room Height 9.5 Feet
4 Room Volume 9614 Cubic Feet
5 Supply Air Volume 900 CFM
6 Air Changes Rate per Hour 30
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

DRYING AREA

Sr. No Parameter Designed

DRYING AREA
1 Room Size 22’ x 7.5’
2 Room Area 165 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 1402.5 Cubic Feet
5 Supply Air Volume 1050 CFM
6 Air Changes Rate per Hour 30
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%
VISITOR CORRIDOR
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

Sr. No Parameter Designed

VISITOR CORRIDOR
1 Room Size 22’ x 7.5’
2 Room Area 165 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 1402.5 Cubic Feet
5 Supply Air Volume 600 CFM
6 Air Changes Rate per Hour 25
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

2nd CHANGING BUFFER

Sr. No Parameter Designed

2nd Changing Buffer
1 Room Size 22’ x 7.5’
2 Room Area 165 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 1402.5 Cubic Feet
5 Supply Air Volume 600 CFM
6 Air Changes Rate per Hour 25
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.003wc)
10 Filtration Up to 95%

3rd BUFFER

Sr. No Parameter Designed

3rd Buffer
1 Room Size 8.5’ x 6’
2 Room Area 51 Square Feet
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

3 Room Height 8.5 Feet

4 Room Volume 433.5 Cubic Feet
5 Supply Air Volume 300 CFM
6 Air Changes Rate per Hour 25
7 Room Temperature 25±2ºC
8 Room Relative Humidity 50±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

QUARANTINE AREA

Sr. No Parameter Designed

Quarantine Area
1 Room Size 48.5’ x 22’
2 Room Area 1067 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 9069.5 Cubic Feet
5 Supply Air Volume 2500 CFM
6 Air Changes Rate per Hour 30
7 Room Temperature 25±2ºC
8 Room Relative Humidity 50±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

PACKING AREA

Sr. No Parameter Designed

Packing Area
1 Room Size 34’ x 23’
2 Room Area 782 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 6647 Cubic Feet
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

5 Supply Air Volume 2000 CFM

6 Air Changes Rate per Hour 30
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

FILLING ROOM / MICRONIZATION AREA

Sr. No Parameter Designed

Filling Room / Micronization Area
1 Room Size 14’ x 23’
2 Room Area 322 Square Feet
3 Room Height 8.5 Feet
4 Room Volume 2737 Cubic Feet
5 Supply Air Volume 1000 CFM
6 Air Changes Rate per Hour 30
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.004wc)
10 Filtration Up to 95%

PACKING MATERIAL AREA BUFFER

Sr. No Parameter Designed

Packing Material Area Buffer
1 Room Size 8.5’ x 7’
2 Room Area 59.7 Square Feet
3 Room Height 10 Feet
4 Room Volume 595 Cubic Feet
5 Supply Air Volume 300 CFM
6 Air Changes Rate per Hour 24
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

7 Room Temperature 25±2ºC

8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.004wc)
10 Filtration Up to 95%

PACKING MATERIAL AREA

Sr. No Parameter Designed

Packing Material Area
1 Room Size 44.5’ x 24’
2 Room Area 1068 Square Feet
3 Room Height 10 Feet
4 Room Volume 10680 Cubic Feet
5 Supply Air Volume 1000 CFM
6 Air Changes Rate per Hour
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

RELEASED STORE BUFFER (Enterance)

Sr. No Parameter Designed

Released Store Buffer (Enterance)
1 Room Size 16’ x9’
2 Room Area 144 Square Feet
3 Room Height 7.5 Feet
4 Room Volume 1080 Cubic Feet
5 Supply Air Volume 300 CFM
6 Air Changes Rate per Hour 25
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

10 Filtration Up to 95%

RELEASED STORE

Sr. No Parameter Designed

Released Store
1 Room Size 50’ x 24’
2 Room Area 1200 Square Feet
3 Room Height 9 Feet
4 Room Volume 10800 Cubic Feet
5 Supply Air Volume 2500 CFM
6 Air Changes Rate per Hour 35
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

RELEASE STORE BUFFER (Exit)

Sr. No Parameter Designed

Release Stor Buffer (Exit)
1 Room Size 13’ x 7’
2 Room Area 91 Square Feet
3 Room Height 9 Feet
4 Room Volume 819 Cubic Feet
5 Supply Air Volume 300 CFM
6 Air Changes Rate per Hour 24
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

1st FLOOR AREA

DISCHARGING ROOM

Sr. No Parameter Designed

Discharging Room
1 Room Size 8’ x 23’
2 Room Area 184 Square Feet
3 Room Height 10 Feet
4 Room Volume 1840 Cubic Feet
5 Supply Air Volume 450 CFM
6 Air Changes Rate per Hour 24
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%
 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

V-MIXER AREA

Sr. No Parameter Designed

V-Mixer Area
1 Room Size 23’ x 23’
2 Room Area 529 Square Feet
3 Room Height 15 Feet
4 Room Volume 7935 Cubic Feet
5 Supply Air Volume 1600 CFM
6 Air Changes Rate per Hour 24
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

MICRONIZATION FEED ROOM

Sr. No Parameter Designed

Micronization Feed Room
1 Room Size 24’ x 23’
2 Room Area 552 Square Feet
3 Room Height 8 Feet
4 Room Volume 4416 Cubic Feet
5 Supply Air Volume 1400 CFM
6 Air Changes Rate per Hour 24
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%

LOBBY

Sr. No Parameter Designed

 Citi Pharma (Pvt.) Ltd
PROCESS VALIDATION REPORT OF HVAC
Doc No: QA/VA/PVR-001/01

Lobby
1 Room Size 22’ x 46’
2 Room Area 1012 Square Feet
3 Room Height 8 Feet
4 Room Volume 8096 Cubic Feet
5 Supply Air Volume 1800 CFM
6 Air Changes Rate per Hour 24
7 Room Temperature 25±2ºC
8 Room Relative Humidity 45±5%
9 Room Pressurization Negative (10 Pa 0.002wc)
10 Filtration Up to 95%