This document provides information on the HVAC system of Platinum Pharmaceuticals including:
- Specialized HVAC terms used in the system design.
- Descriptions of 16 air handling units serving different production areas.
- Filtration specifications for different areas based on ISO class requirements.
- Key parameters to monitor for HVAC system performance such as air flow, temperature, humidity and microbial testing.
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HVAC (Heating, Ventilation and Air Conditioning) is a
major sub-discipline of Mechanical Engineering. The goal of
HVAC design is to balance indoor environmental comfort
with other factor such as installation cost, ease of
maintenance and energy efficiency.
The discipline of HVAC includes a large number of
specialized terms, some of which are listed in the next slide.
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HVAC
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SPECIALIZED TERMS
Operation & Control Units
Chiller
Cooling towers
Condenser
Water Circulation Pumps (Chill water & Condenser Water)
Piping network
Air Handling Units
Supply / Return ducting Network
Supply / Return Air Diffusers
Filtration system
Coil
Air Conditioner (Quality Control LAB)
Constant Air Volume
Actuator / Motorize Valve
Damper
Dehumidifiers
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PRE FILTER
G4
PRE FILTER
65%
(washable at
fresh air intake
and exhaust)
BAG FILTER
85 & 95% (85%
on both supply
and return and
95% on supply)
HEPA
FILTRATION
99.995%
(HEPA filter
integrity test)
PROD. AREA
DUST
COLLECTOR
(CLOTH
FILTER)
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Air Flow in Cubic Feet per Minute (CFM)
Test CFM as pre defined supply / Return Air defined limits.
Humidity:
As per product requirement but in general set the humidity (RH) limits in 45% - 55%.
Temperature:
As per designed specifications noted room temperature normal (230C +/-20C) / 70F - 74F
Air Flow pattern:
Test air flow and patterns negative / positive as per designed by consultant according to nature
of activity.
Pressure Differentials:
Across the room/corridor test pressure differentials to minimize product contamination.
Particular Count:
Test the particle count in the area.
Bag filters / HEPA filter integrity:
Check the integrity of HEPA filter and monitor through pressure difference across the filter.
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1. Granulation, Drying, Blending and Milling
2. Compression
3. Encapsulation
4. Dispensing
5. Solid Packaging Hall
6. Quality Control
7. Semi Solid Manufacturing and Filling
8. Liquid Filling with Bottle Blowing
9. Mouth wash Filling with Bottle Blowing
10. Liquid Packing Hall and Coding Area
11. Liquid Corridor
12. Semi Solid Packing Hall and In-Process Qrtn.
13. Blister Cubicle and Corridor, Klockner-1&2, CAM & UPS
14. Technical Office Area
15. Tableting Corridor
16. Dry syrup Area
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13. 1. AHU # 01
Service Area: GRANULATION &
DRYING
Total Supply Air (CFM): 3450
Discharge Air Pressure: 750 PA
Refrigeration Load: 12.4 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 30 US GPM
2. AHU# 02
Service Area: COMPRESSION
Total Supply Air (CFM): 3450
Discharge Air Pressure: 750 PA
Refrigeration Load: 13.1 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 31 US GPM
3. AHU # 03
Service Area: ENCAPSULATION
Total Supply Air (CFM): 3480
Discharge Air Pressure: 700 PA
Refrigeration Load: 13.8 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 34 US GPM
4. AHU# 04
Service Area: DISPENSING
Total Supply Air (CFM): 1420
Discharge Air Pressure: 625 PA
Refrigeration Load: 9.6 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 23 US GPM
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14. 5. AHU # 05
Service Area: SOLID PACKING
HALL
Total Supply Air (CFM): 2850
Discharge Air Pressure: 700 PA
Refrigeration Load: 5.4 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 32 GPM
6. AHU# 06
Service Area: OLD QC
Total Supply Air (CFM): 3200
Discharge Air Pressure: 700 PA
Permissible Air Flow: 500 FPM
Filtration:F6-F8
Chill Water Flow (max.): 32 GPM
7. AHU # 07
Service Area: SEMI-SOLID
MANUFACTURING AND FILLING
Total Supply Air (CFM): 7150
Discharge Air Pressure: 1400 PA
Refrigeration Load: 27.25 RT
Filtration: G4-F6-F9-H13
Chill Water Flow (max.): 55 GPM
8. AHU# 08
Service Area: LIQUID FILLING
WITH BOTTLE BLOWING
Total Supply Air (CFM): 2420
Discharge Air Pressure: 1400 PA
Refrigeration Load: 9.42 RT
Filtration: G4-F6-F9-H13
Chill Water Flow (max.): 16 GPM4/21/2015 14
15. 9. AHU # 09
Service Area:
MOUTH WASH FILLING WITH
BOTTLE BLOWING
Total Supply Air (CFM): 1950
Discharge Air Pressure: 1400 PA
Refrigeration Load: 6.31 RT
Filtration: G4-F6-F9-H13
Chill Water Flow (max.): 15 GPM
10. AHU# 10
Service Area: LIQUID PACKING
HALL & COADING
Total Supply Air (CFM): 4270
Discharge Air Pressure: 975 PA
Refrigeration Load: 24.42 RT
Filtration: G4-F6-F9
Chill Water Flow (max.): 49 GPM
11.AHU # 11
Service Area: LIQUID CORRIDOR
Total Supply Air (CFM): 2650
Discharge Air Pressure: 975 PA
Refrigeration Load: 16.42 RT
Filtration: G4-F6-F9
Chill Water Flow (max.): 33 GPM
12. AHU# 12
Service Area: SEMI-SOLID
PACKING HALL AND IN PROCESS
QRTN.
Total Supply Air (CFM): 3820
Discharge Air Pressure: 1575 PA
Refrigeration Load: 10.36 RT
Filtration: G4-F6-F9
Chill Water Flow (max.): 21 GPM
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16. 13. AHU # 13
Service Area: BLISTER,
KLOCKNER 1,2, CAM BLISTER
Total Supply Air (CFM): 5070
Discharge Air Pressure: 1300 PA
Refrigeration Load: 20.5 RT
Filtration: G4-F6-F9-H13
Chill Water Flow (max.): 43 GPM
14. AHU# 14
Service Area: TECH. OFFICE AREA
Total Supply Air (CFM): 3450
Discharge Air Pressure: 200PA
Refrigeration Load: 6.8 RT
Filtration: F6-F8
Chill Water Flow (max.): 14.20 GPM
15. AHU # 15
Service Area: TABLETING
CORRIDOR
Total Supply Air (CFM): 3200
Discharge Air Pressure: 200 PA
Refrigeration Load: 20.5 RT
Filtration: F6-F8
Chill Water Flow (max.): 16.40 GPM
16. AHU# 16
Service Area: POWDER FILLING
Total Supply Air (CFM): 2850
Discharge Air Pressure: 150 PA
Refrigeration Load: 20.5 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 13.10 GPM
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05 NOS AHUS (CEPH)
&
SINGLE CENTRAL
DEHUMIDIFIER
1. Corridor, Conventional Coating Pan & Quality Control AHU # 01
2. Supervisor Room, Corridor, Compression, Encapsulation, Milling,
Blending, Granulation & In-Process Qrtn. AHU# 02
3. Packaging Hall , Corridor & Qrtn. AHU # 03
4. Raw Material store & Dispensing. AHU# 04
5. Dry Syrup, Blister and Bottle Blowing. AHU # 05
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18. 1. AHU # 01
Service Area: In-Process Qrtn,
Control Room, Coating & Passage.
Total Supply Air (CFM): 2030
Discharge Air Pressure: 1650 PA
Refrigeration Load: 12.25 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 24 US GPM
2. AHU# 02
Service Area: Milling, Granulation,
Supervisor Room, Corridor,
Compression, Encapsulation,
Blending, & In-Process Qrtn.
Total Supply Air (CFM): 10430
Discharge Air Pressure: 1650 PA
Refrigeration Load: 33.75 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 68 US GPM
3. AHU # 03
Service Area: Packaging Hall ,
Corridor & Qrtn.
Total Supply Air (CFM): 3350
Discharge Air Pressure: 1000 PA
Refrigeration Load: 13.58 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 27 US GPM
4. AHU# 04
Service Area: Raw Material Store &
Dispensing
Total Supply Air (CFM): 1190
Discharge Air Pressure: 1650 PA
Refrigeration Load: 3.8 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 08 US GPM
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19. 5. AHU # 05
Service Area: Dry Syrup, Blister and
Bottle Blowing
Total Supply Air (CFM): 3830
Discharge Air Pressure: 1650 PA
Refrigeration Load: 12.4 RT
Filtration: G4-F6-F8-H13
Chill Water Flow (max.): 25 US GPM
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20. 1. Blister AHU # 01
2. Compression & Encapsulation AHU# 04
3. Corridor AHU # 05
4. Granulation, Drying & Blending AHU# 06
5. Finished Goods store AHU # 07
6. Packing Hall & Corridor AHU # 09
7. Physician sample Store AHU# 10
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7 NOS AHUS (HARMONE)
Prepared By: Engineering Department
21. 1. AHU # 01
Service Area: BLISTER
Total Supply Air (CFM): 2850
Discharge Air Pressure: 150 PA
Refrigeration Load: 4.3 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 13.10 GPM
2. AHU# 04
Service Area: COMPRESSION &
ENCAPSULATION
Total Supply Air (CFM): 3350
Discharge Air Pressure: 200 PA
Refrigeration Load: 6.8 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 4.70 GPM
3. AHU # 05
Service Area: CORRIDOR
Total Supply Air (CFM): 1400
Discharge Air Pressure: 1250PA
Refrigeration Load: 2.5 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 6 GPM
4. AHU# 06
Service Area: GRANULATION,
DRYING & BLENDING
Total Supply Air (CFM): 4100
Discharge Air Pressure: 200 PA
Refrigeration Load: 10 RT
Filtration: G4, F6 & F8
Chill Water Flow (max.): 24 GPM
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22. 6. AHU # 09
Service Area: PACKING HALL &
CORRIDOR
Total Supply Air (CFM): 5700
Discharge Air Pressure: 200 PA
Refrigeration Load: 10.9 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 26.20 GPM
7. AHU# 10
Service Area: PHYSCIAN SAMPLE
Total Supply Air (CFM): 2850
Discharge Air Pressure: 150 PA
Refrigeration Load: 5.5 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 13 GPM
5. AHU # 07
Service Area: FINISHED GOOD
STORE
Total Supply Air (CFM): 7200
Discharge Air Pressure: 200 PA
Refrigeration Load: 11.5 RT
Filtration: G4-F6-F8
Chill Water Flow (max.): 30 GPM
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ISO Class
S.No Area Class
1 Solid Manufacturing 100,000
2 Liquid Manufacturing 10,000
3 Solid Packing 100,000
4 Liquid Packing 10,000
5 Raw Material Store 100,000
6 Dispensing 100,000
7 Buffer 100,000
8 Dry Syrup Filling & Packing 10,000
9 Semi Solid Manufacturing 10,000
10 Semi Solid Packing 10,000
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In-coming / Return Air
Air Changes of the area
Direction of flow / pressure differentials
Temperature
Humidity
Microbial contamination Testing
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27. OPERATION PARAMETER UNITED STATES EU COMMUNITY
NON-
STERILIZED
PRODUCT OR
CONTAINER
(CONTROLLED
AREA)
AIR FLOW RATE Minimum 20 air
changes/hr
Higher than 20 air
changes / hr.
4/21/2015 27Prepared By: Engineering Department