ENVIRONMENTAL CONTROL

Air Handling, Air Conditioning and

Refrigeration
Compiled & delivered by,

Mr. N. G. Shinde
Assistant Professor,
Department of Pharmaceutics,
Satara College of Pharmacy, Satara.
2015-2016
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Factors contributing to quality products

Personnel
Validated processes

Procedures

Starting materials
Equipment

Packing materials

Premises

Environment
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
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
Cross-Contamination
What is Cross-Contamination ?

Contamination of a starting material, intermediate

product, or finished product with another starting
material or product during production.
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

 Cross-Contamination

Contaminant
Contaminant
from
Contamination from
Environment
Equipment
Operators

Product
Product
from Cross
from
Environment Contamination
Equipment
Operators
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
“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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 HVAC
HVAC – Heating, Ventilation, Air-conditioning

Temperature 68°F (20°C) and 75°F (25°C)

Humidity 30% relative humidity (RH) and 60% RH

Pressure A slightly positive pressure to reduce

outside air infiltration.

Ventilation Rooms typically have several

complete air changes per hour

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

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 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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Block Diagram

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 Components Of HVAC System
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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 Classification Of Clean Room :
REGULATORY POINT OF VIEW
US Federal Standard 209E

Clean Room Class Limits "not to exceed" particles per

Class cu ft for particle sizes shown

0.1∝m 0.2∝m 0.3∝m 0.5∝m 5 ∝m

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

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 HEPA FILTER : At Glance

High Efficiency Particulate Air capture a minimum of

99.97% of contaminants at 0.3 microns in size.
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:
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
 Parameter Test Frequency
Particulate monitoring in air 6 Monthly

HEPA filter integrity testing Yearly
(DOP testing

Air change rates 6 Monthly

Air pressure differentials Daily

Microbiological monitoring Daily

by settle plates

Temperature and humidity Daily

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Air flow patterns
Filtered air entering a production room or
covering a process can be
turbulent
uni-directional (laminar)
GMP aspect
economical aspect

New technologies: barrier technology/isolator technology.

 Air flow patterns

Turbulent Uni-directional / laminar

dilution of dirty air displacement of dirty air

0,30 m/s
 Air flow patterns Prefilter
Annex 1, 17.3
AHU

Main filter

1 2 3

Turbulent Uni-directional Turbulent

 Air flow patterns
Workbench (vertical) Cabin/ booth Ceiling
 Positioning of filters

AHU mounted final filter Filter in terminal position

HEPA
Filter

Production Room

Production Room

HEPA Filter
Positioning of filters
Final filter

AHU
Prefilter

1 2
 Air re-circulation
The filtered air entering a production room can be

100% exhausted or
a proportion re-circulated

GMP aspect
economical reasons
Ventilation with 100% fresh air (no air re-circulation)

Washer (optional)
Exhaust Unit

Central Air Handling Unit

Production Rooms
Ventilation with re-circulated air + make-up air

Exhaust Unit

Central Air Handling Unit

Return air
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 Air conditioning
It is the process of treating the air so as to control its temp.,
humidity, cleanliness and distribution simultaneously to meet
the requirements of the conditioned space.

Applications:
Promoting the human comfort
Maintenance of proper conditions for manufacture, processing and
preserving of material and equipment.
Environmental test chamber
Maintenance of animal and equipment

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 Types of equipment

1.Self contained air conditioner/ Unitary/ Packaged

2.Central air conditioner/ Field erected

1.Self contained air conditioner/ Unitary/ Packaged

These system include window mounted or wall bracket conditioners.

Most of this units are air cooled through water cooled type.
Room air enters the casing at the front panel. It is mixed with part of
the outdoor air and this mixture is forced over a cooling coils by a
centrifugal fans.
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 Central air conditioning system

In this system one or several areas are air conditioned by duct

network.
Air cleaning is done by filters.
Cooling is achieved by using water or by direct expansion in
refrigerated coils or air washers.
Heating is achieved by using steam or hot water coils.

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Definitions
Humidity:
The amount of water vapour present in moist air per unit mass of the
dry air in given volume.
Dew point:
The temperature at which the liquid droplets just appear when the
moist air is cooled continuously.
Dry bulb temperature:
The actual temperature of gas or mixture of gases indicated by an error
free temperature measuring device.
Wet bulb temperature:
Dynamic equilibrium temperature attained by a water surface when
exposed to air under adiabatic conditions.
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 Measurement of humidity

Direct method

A known volume of air is drawn through phosphorus pentoxide.

The moisture present in the air get absorbed and determined by

chemical or gravimetric method.

From the difference of initial and final masses humidity is

estimated.

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Psychrometric methods
Determination of wet bulb and dry bulb temperatures.

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Dew point method
In this method formation of mist and disappearance of
mist is considered and dew point is calculated.
A cooled and polished disk is placed in vessel
containing the gas whose humidity is to be determined.
The temp. of the disk is gradually lowered using liquid
air or liquid carbon dioxide or ether.
Soon mist condenses on polished surface.
The temperature at which mist just appeared is noted.
The temp. of disk is slowly increased and disappearance
of mist is observed and temp. is noted.
The average of these two temperatures represent
accurate dew point.
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Humidification
The process of increasing the moisture in the air.
Approaches:
The air may be brought in contact with water in
such a way that only a part of the water is
evaporated.
Cooling towers are utilized.
The incoming air is heated to higher temp. then
cooled adiabatically with water to achieve desired
humidity.
The air may be mixed with stream of air of higher
humidity. 47
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Dehumidification
Removal of moisture from the air.
Dehumidification is achieved by bringing the moist air in
contact with cold surface (solid/liquid).
In pharmaceutical industry many operations are carried out at
stated temperature and humidity to get optimum results.

In many parts of India (Bengal, Kerala) air is very humid so it

becomes very difficult to carryon operations with hygroscopic
substances even in AC room. Hence, dehumidifiers are installed
for such operations.

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Dehumidifier
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 Conclusion
Air handling systems:

Play a major role in the quality of pharmaceuticals

Must be designed properly, by professionals
Must be treated as a critical system
Thank you

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