The document discusses the importance of environmental control in the pharmaceutical industry. It states that controlling factors like particulate matter, microorganisms, temperature, humidity and airflow is crucial to protecting pharmaceutical products from contamination. A properly designed, validated and monitored HVAC system is necessary to ensure quality and safety. The HVAC system controls air movement and distribution of temperature and humidity in cleanrooms to maintain suitable manufacturing conditions.

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ENVIRONMENTAL CONTROL
Air Handling, Air Conditioning and
Refrigeration

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 Environmental control of pharmaceutical cleanrooms is essential to the
manufacture of a quality product.
 Control of such conditions as airborne particulate, microorganisms,
temperature, humidity, differential pressure, airflow, air velocity and
personnel is crucial to protect the product from contamination.
 Therefore, the design, validation and ongoing monitoring of a cleanroom
HVAC system are necessary to assure the quality and safety of the
pharmaceutical product.
Why is environment control needed in a Pharma industry?

3. Factors contributing to quality products
Starting materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing materials

4. The manufacturing environment is critical for
product quality
1. Light
2. Temperature
3. Humidity
4. Air movement
5. Microbial contamination
6. Particulate contamination
7. Uncontrolled environment can lead to product degradation
product contamination
loss of product and profit

5. What are contaminants ?
Contaminants are
1. Products or substances other than product
manufactured
2. Foreign products
3. Particulate matter
4. Micro-organisms
5. Endotoxins (degraded micro-organisms)
Cross-contamination is a particular case of contamination

6. Cross-Contamination
What is Cross-Contamination ?
Contamination of a starting material, intermediate
product, or finished product with another starting
material or product during production.

7. Cross-Contamination
From where does Cross-Contamination originate?
1. Poorly designed air handling systems and dust extraction
systems
2. Poorly operated and maintained air handling systems and
dust extraction systems
3. Inadequate procedures for personnel and equipment
4. Insufficiently cleaned equipment

8. Contamination
Contaminant
from
Environment
Operators
Contaminant
from
Equipment
Cross
Contamination
Product
from
Environment
Operators
Product
from
Equipment
Cross-Contamination

9. Cross-Contamination
Cross-contamination can be minimized by:
1. Personnel procedures
2. Adequate premises
3. Use of closed production systems
4. Adequate, validated cleaning procedures
5. Appropriate levels of protection of product
6. Correct air pressure cascade

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“CLEANLINESS, CLEANLINESS and
CLEANLINESS”

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A Heating system (“H” in HVAC)
A Ventilating system (“V” in HVAC)
A Cooling system (“AC" in HVAC)

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17. HVAC
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HVAC – Heating, Ventilation, Air-conditioning
Temperature
Humidity
Pressure
Ventilation
68°F (20°C) and 75°F (25°C)
30% relative humidity (RH) and 60% RH
A slightly positive pressure to reduce
outside air infiltration.
Rooms typically have several
complete air changes per hour

18. What can HVAC do?
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Control airborne particles, dust and micro-
organisms
Maintain room pressure (delta P)
Maintain space moisture (Relative Humidity)
Maintain space temperature

19. What HVAC can’t do?
1. HVAC can not clean up the surfaces of a
contaminated places, room or equipment
2. HVAC can not compensate for workers who do not
follow procedures
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20. Block Diagram
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21. Local heating systems
heat source, distributors, and Portable electric heaters, built-in
electric resistance heaters, infrared heaters and wood stoves
Local cooling systems
Air circulation devices, such as paddle or desk fans
Local ventilating systems
Local air-conditioning systems
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Components Of HVAC System

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Clean Room
Class
Class Limits "not to exceed" particles per
cu ft for particle sizes shown
0.1µm 0.2µm 0.3µm 0.5µm 5 µm
1 35.0 7.50 3.0 1.0 --
10 350 75.0 30.0 10.0 --
100 -- 750 300 100 --
1000 -- -- -- 1000 7.0
10000 -- -- -- 10000 70.0
10000 -- -- -- 100000 700
Classification Of Clean Room :
REGULATORY POINT OF VIEW
US Federal Standard 209E

23. HEPA FILTER : At Glance
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High Efficiency Particulate Air capture a minimum of
99.97% of contaminants at 0.3 microns in size.

24. Monitoring and Testing of HVAC Clean
Room
Physical
Air borne particulate matter
HEPA integrity
Air Changes per hour
Flow pattern in room
Pressure Diff across filter
Temperature and Humidity
Microbiological
Settling Plate
Slit Plate
Surface Sampling

25. Parameter Test Frequency
Particulate monitoring in air

HEPA filter integrity testing
(DOP testing
Air change rates
Air pressure differentials
Microbiological monitoring
by settle plates
Temperature and humidity
6 Monthly
Yearly
6 Monthly
Daily
Daily
Daily
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Thank you