HVAC System

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A PresentationOnHUMIDITY, TEMPERATURE,HVAC
SYSTEM PHARMACEUTICALS
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Temperature, humidity, heating, ventilation and
air-conditioning play an important role in
ensuring the manufacture of quality
pharmaceutical products.

• Humidity And Pharmaceutical Products

• The amount of water vapor in the air is referred
  to as humidity. Humidity can be measured in a
  number of ways
• Absolute humidity,
• Specific humidity
• Relative humidity

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Benefits of control of humidity
Problems and benefits of Humidity

• Effects of humidity can have detrimental effects
  on
• Product quality,
• Yield,
• Visual appearance and
• Shelf-life.

• Reproducibility of results
• Reduced friability during tablet compression
• Reduced drying time in fluid bed driers
• Improved appearance of coated tablets
• Improved Packaging processes
• Improved shelf-life
• Reduction of micro-biological growth

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Temperature is a physical property of matter that
quantitatively expresses the common notions of
hot and cold.

• Temperature and Pharmaceutical Products

Effect of Temperature on Products

• Typically a 10c increase in temperature can
  produce a 2-5 fold increase in decay of
  products
• Stability
• Efficacy
• Shelf life
• Appearance
• Solubility
• Storage condition

Temperature Control
The temperature is controlled by applying HVAC
system.
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Heating, Ventilation, Air conditioningHVAC
regulates Room temperature, Humidity, Air
quality, Air flow.

• HVAC System

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• HVAC consists
• Air conditioner
• AHUs
• Dehumidifier / Heater
• Filters (Pre HEPA)
• Dust Extractors
• Ducting (For delivery of controlled air)
• Supply Fans
• Smoke Detector
• Dampers
• Humidity / Temperature / Pressure sensors
• Bag Filters
• Heating / Cooling Coils

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• Typical Air Flow Patterns

HVAC system design parameters

• Energy efficiency
• Cleanliness
• Cost
• Temperature uniformity

• Humidity control
• Chemical exhaust efficiency
• Noise control

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• Various Air Flow patterns

Cabin/ Booth
Working bench
Ceiling
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• COMPONENTS OF HVAC SYSTEM

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• Monitoring of HVAC Components

A Particulate monitoring in air Monthly Daily
B HEPA filter integrity testing Yearly
C Air change rate Monthly
D Temperature and Humidity Daily
E Air pressure differentials Daily
F Microbiological monitoring Daily ( In aseptic areas) Decreased frequency in other areas
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• HVAC SPECIFICATIONS

Temperature 18-23 o C
Relative humidity 45 5 Dry powder- 30 5 Moisture sensitive drug- 5 5
Air velocity 80- 120 ft/min
Air flow Laminar airflow
Pressure gradient 15 Pascal
Particulate count (Critical area) NMT 100 particles of 0.5 µm/ft3
Air system failure alarm (ASFA)
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1. HVAC can not clean up the surfaces of a
contaminated places, room or equipment2. HVAC
can not compensate for workers who do not follow
procedures

• HVAC cant do

Conclusion
A high quality environment can ensure safe
quality product. So following of HVAC system is
must for any Pharmaceutical Company.
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