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Anil Mahajan
Shailendra Chitari
Durgesh Sadh
Dushyant Malla
Ravindra Goyal
Swadesh Jain
Dharmendra Singh
Rajesh Kumar Soni
Vipin Kushwah
Shiv Kumar Mahajan


Rajesh Soni
Shri G.S. Institute of Technology & Science

Department of Mechanical Engineering


We are pleased to recommend that the dissertation work of Anil Mahajan

entitled ‘Demonstration Model of HVAC System for Clean Room
Application’ is accepted in partial fulfillment of the degree of Bachelor of
Engineering in Mechanical Engineering.

Dr. M.L. Jain Prof. Dr. Basant Kumar Agrawal

Head of Mechanical Department Mechanical Engineering




Shri G.S. Institute of Technology & Science

Department of Mechanical Engineering


This is to certify that the dissertation work of Anil Mahajan entitled

‘Demonstration Model of HVAC System for Clean Room Application’ is
accepted in partial fulfillment of the degree of Bachelor of Engineering in
Mechanical Engineering.

Internal Examiner External Examiner

Date: Date:


I owe a great many thanks to a great many people who helped and
supported me during the working on this project.

My deepest thanks to Professor, Dr. Basant Agrawal the Guide of the

project for guiding and correcting various documents of mine with attention and
care. He has taken pain to go through the project and make necessary
correction as and when needed.

I express my thanks to the Principal & HOD of Mechanical

extending their support.

I would also thank my Institution and my faculty members without whom

this project would have been a distant reality. I also extend my heartfelt thanks
to my family and well wishers.


“Comfort can increase Human work efficiency” It is very interesting to see

around us the Big malls, Theatres, Hotels, Hospitals & Industries are equipped
with HVAC system to provide more comfort to their customers or employees,
this releases the stress level.

The scope of this project is to study the “HVAC” as a system & try to provide a
Study Platform in form of “Demonstration Model of HVAC system”. We have
studied various literatures, books & Internet Material on HVAC applications,
with above objective & found, use of HVAC system in Clean room of
Pharmaceutical industry is quite interesting & it is also different from the
applications we studied during course or sees our day today life.

We tried to demonstrate the “HAVC System with Clean room application” in

our Project model & captured detailed information about HVAC system in this
project report.


2.2 WHAT IS HVAC? 11
2.4 NEED OF HVAC! 13
2.6.1 DUCTS 17




You’ve probably heard of the term from different contractors, engineers, or

perhaps colleagues and business partners; but you’re still wondering what the
initialism means. Well, HVAC (“H-V-A-C” or “H-VAK”) stands for Heating,
Ventilation, and Air-Conditioning—three closely related fundamental functions
found in homes, offices, and other building structures.

The beginning of HVAC is not clear, though as early as second century, a lot of
Roman cities were using a central heating system known as hypocaust. This is
further popularized during the Industrial Revolution as big factories used it. Now
most modern buildings that you see have integrated HVAC.

The HVAC system is also known as climate control. This is because these
three functions are essential in maintaining comfort in every dwelling.

The primary use of HVAC is to regulate room temperature, humidity, and air
flow, ensuring that such elements remain within their acceptable ranges.
Effective control of such factors minimizes health-related risks.


Heating is significant in maintaining adequate room temperature especially

during colder weather conditions. There are two classifications of heating: local
and central. The latter is more commonly used because it is more economical.
Furnace or boiler, heat pump, and radiator make up the heating system.

Ventilation, on the other hand, is associated with air movement. There are
many types of ventilation, but they all function similarly. Ventilation is necessary
to allow carbon dioxide to go out and oxygen to get in, making sure that people
are inhaling fresh air. Stagnant air causes the spreading of sickness, usually

airborne, and allergies. But it is also essential to maintain an efficient ventilation
system, especially in the attics. Insufficient ventilation usually promotes the
growth of bacteria and fungi such as molds because of high humidity. It will also
decrease the effectiveness of rafter and roof sheathing insulation because of
water vapor condensation.

The air-conditioning system controls the heat as well as ventilation. They

often come in different sizes. Most air conditioners have large air ducts, so it is
better to check out the building first to see if they can be installed. Or else, you
can use the split system or remote coils. It is necessary, though, that air ducts
are properly cleaned. Pathogens thrive in dirty air ducts. Return-air grills are
also vulnerable to chemical, microbiological, and radiological elements. Thus,
HVAC return-air grill height should be that it is not accessible but visible for any

1.3 History of HVAC

The Greeks or the Romans were a smarter and they had some or the other
means to bring them thermal comfort. Let’s take a quick look as what form of
HVAC system our history had, if there were any. We definitely won’t find
anything similar or even near to the technology we use nowadays but there
must be some form of comfort providing system.

Period 1000s-1400s

This was a period of Greeks, Romans, Egyptians, Chinese and of course the
Indians. While Egyptian’s used to use man powered fans, the Indians used to
use rope fans. Roman’s used to use something known as hypocaust (a central
heating system which has furnace in the basement and flues to distribute heat).
It has a system for radiating heat for rooms and even steam for the bath of the
rich. Chimneys were used extensively towards the start of 1400s which allowed
people to have private rooms. It is also known that Leonardo Da Vince built
water driven fan to ventilate a suite of rooms.

Period 1500s- 1600s

In France, ventilating machines were used in the mines. These machines used
to have a series of fans with blades which used to direct fresh air into the shaft.
This was the time when the idea of houses with chimneys came to America
from Europe. Large quantities of wood and coal were used during that era for
heating their homes. Invention of thermometer by Galileo changed the way
temperature was measured till then. Ferdinand II developed a thermometer
independent of air pressure. This was the time when the very first gravity
exhaust ventilation system was made for the US House of the Parliament.

Period 1700s-1800s

Initially many countries used to use stove built of bricks or fuller’s earth.
Fahrenheit invented the first mercury thermometer. The first ventilator using
centrifugal fan was made.

The era saw a series of important inventions that changed the lifestyle of the
people of the whole world. Benjamin Franklin invented the very first stove which
is supposed to be known as the first steam heating system. Then a series of
some vital discoveries by Joseph Black including latent heat changed the way
heat and temperature was perceived. James Watt brought a revolution by
inventing the steam engine. A stove with a furnace for heating air was used in
England. This arrangement had system of pipes which could heat up even big
factories. Today that arrangement is known as direct fired heat exchangers.

Heat developed from friction was considered a form of vibrations. Carnot

founded thermodynamics and James Joule discovered that work produces
heat. Heat started to be considered as a form of energy. Hot water heating
systems were used for large commercial and public buildings. Also the first
warm furnace is developed. Houses with water spray system to humidifying and
cooling were used. Supply air and exhaust air systems started to be driven by
steam engines. Also the law of conservation of energy is discovered. The first
and second laws of thermodynamics were made. Boilers with higher capacity
were used. Laws of gases were discovered and widely put to use.

Period 1900s

This era saw a sudden steep in the inventions and evolution of the HVAC
systems. Furnace system with centrifugal fans, high pressure steam heating
systems, massive fan systems and high speed centrifugal fans and axial flow
fans with small electric motors were in extremely high usage. The first fan coil
dehumidifying system was made by a company called Buffalo Forge. The same
company made the first spray type air conditioning device. The first railway and
industrial air conditioning system was devised by Sturtevant, including a
backward inclined blade centrifugal pump. Buffalo Forge designed a system to
remove dust particles from air streams.

The HVAC industry started using Scotch Maine type boilers with oil and gas
burners and induced or forced type fans were used. A system which brings
down the temperature to 10 degree Fahrenheit but increases the humidity to
uncomfortable levels was made. The Rational Psychometric Formulae for
fundamental calculations was invented. A forced air system which uses a fan
was made. The first centrifugal refrigeration machine was made for air
conditioning large spaces.

Hydronic circulatory pumps and radiators started to be used in the air

conditioning systems for circulating water in the system. The first refrigeration
with a compressor was made. The first residential air conditioning was made.
Room coolers that use the technology of the refrigerators were made. Panels
for heating floors and ceilings started to be made. The use of solar power as a
power source was made. The first man walks on moon with life support and
cooling systems.

The heating pump heats on the reverse refrigeration cycle and on lower outdoor
temperatures. Due to the over usage of refrigerants the environment was
endangered and thus the United Nations Montreal Protocol for protection of
earths ozone layer was signed. With the help of international co operation
chlorofluorocarbon (CFC) which depletes ozone layer was phased out from
usage. A multi million dollar research program on air conditioning and
refrigeration system began.

Future OF HVAC

“We will see larger improvements in energy efficiency over the next 15 years
than we have ever seen in the history of air-conditioning - not just in peak-load
improvements, but in energy efficiency throughout the year.”

The changes will be holistic - not only technological changes to HVAC systems
themselves, but also to how buildings are designed and built. How a building is
sited and its windows, insulation, and lighting will also come into play. “The
value of energy is going up,

“It’s going to require more-efficient systems and different power-generation and

-distribution methods. The economics of all that is changing.”

1.4 NEED of HVAC

A very humid atmosphere impairs the body’s ability to regulate body

temperature as it prevents the evaporation of sweat. High humidity also
decreases physical strength, which usually leads to fatigue. An unhealthy
surrounding can also affect people’s thinking abilities. Hypothermia, heat
stroke, and hyperpyrexia, among others, are some of the illnesses that may
also occur.

Heating, ventilating, and air conditioning (HVAC) systems provide the people
working inside the buildings with “conditioned air” so that they will have a
comfortable safe working environment. People respond to their work
environment in many ways and many factors affect their health, attitude and
productivity. “Air quality” and the “condition of the air” are two very important
factors. By “conditioned air” and “good air quality”, we mean that air should be
clean and odor-free and the temperature, humidity, and movement of air will be
within certain acceptable comfort ranges.

ASHRAE, the America Society of Heating, Refrigerating and Air Conditioning

Engineers, has established standards which outline indoor comfort conditions
that are thermally acceptable to 80% or more of commercial building’s
occupants. Generally, these comfort conditions, sometimes called the “comfort
zone”, are between 68°F and 75°F (20°C and 23.89°C) for winters and 73°F to
78°F (22.78°C and 25.56°C) during the summers. Both these ranges are for
room air at approximately 50% Relative humidity and moving at a slow speed
(velocity) of 30 feet per minute or less.




To maintain the proper temperature and humidity in the conditioned space the
cooling cycle is this: The supply air (which is 20°F cooler than the air in the
conditioned space) leaves the cooling coil and through the supply air fan, enters
in to the duct and then into the conditioned space. The cool supply air picks up
heat in the conditioned space. The warmed air makes its way into the return air
inlets, then into the return air duct, and back to the air handling unit. The return
air goes through the return air fan into the mixed air chamber and mixes with
the outside air. The mixed air goes through the filters and into the cooling coil.
The mixed air flows through the cooling coil where it gives up its heat into the

chilled water tubes in the coil. This coil also has fins attached to the tube to
facilitate heat transfer. The cooled supply air leaves the cooling coil and the
cycle repeats. The water, after picking up heat from the mixed air, leaves the
cooling coil and goes through the chilled water return (CHWR) pipe to the water
chiller’s evaporator. The “warmed” water flows into the chiller’s evaporator ----
sometimes called the water cooler --- where it give up the heat from the mixed
air into the refrigeration system. The newly “chilled” water leaves the
evaporators, goes through the chilled water pump (CHWP) and is pumped
through the chilled water supply (CHWS) piping into the cooling coil to pick up
heat from the mixed air and the water cycle repeats. The evaporator is a heat
exchanger that allows heat from chilled water return (CHWR) to flow by
conduction into the refrigerant tubes. The liquid refrigerant in the tube “boils off”
to a vapor removing heat from the water and conveying the heat to the
compressor and then to the condenser. The heat from the condenser is
conveyed to the cooling tower through the condenser water in the condenser
return (CWR) pipe. As the condenser water cascades down the tower, outside
air is draw across the cooling tower removing heat from the water through the
process of evaporation. The “cooled” condenser water falls to the bottom of the
tower basin and is pumped from the tower through the condenser water pump
(CWP) and back to the condenser water supply piping (CWS) and the cycle

1.6 PARTS of HVAC Systems

An HVAC system is simply a group of components working together to move

heat to where it is wanted (the conditioned space) or remove heat from where it
is not wanted (the conditioned space), and put it where it is unobjectionable (the
outside air).

The components in a typical HVAC system consists:

1. Fan: An indoor fan (blower) is to circulate the supply and return air.

2. Supply Air Ducts: Supply air ductwork in which the air flows from the fan to
the room.

3. Air Distribution Devices: Air devices such as supply air outlets and return air

4. Return Air Duct: Return air ductwork in which the air flows back from the
room to the mixed air chamber.

5. Mixed Air Chamber: A mixed air chamber to receive the return air and mix it
with outside air.

6. Outside Air Device: An outside air device such as louver, opening or duct to
allow for the entrance of outside air into the mixed air plenum.

7. Filter Section: A filter section to remove dirt and dust particles from the air.

8. Heat exchangers such as refrigerant evaporator and condenser coil for

cooling, and a furnace for heating.

9. A compressor to compress the refrigerant vapor and pump the refrigerant

around the refrigeration system.

10. Condenser Fan: An outdoor fan (blower) to circulate outside air across the
condenser coil.


Classification of ducts: The ducts may be classified as follows:

 Supply air duct: the duct which supplies the conditioned air from the air
from the air conditioning equipment to the space to be conditioned, is
called supply air duct.

 Return air duct: the duct which carries the recalculating air from the
conditioned space back to the air conditioning equipment is called return
air duct.

 Fresh air duct: The ducts which carry the outside air is called fresh air

 Low pressure duct: When the static pressure in the duct is upto 50mm of
water gauge, the duct is said to be a low pressure duct.

 Medium pressure duct : When the static pressure in the duct is upto 150
mm of water the duct is said to be a medium pressure duct.

 High pressure duct : When the static pressure in the duct is upto 150 to
250 mm of water the duct is said to be a high pressure duct.

 Low velocity duct: When the velocity of air in the duct is upto 600 m/min ,
the duct is said to be a low velocity duct.

 High velocity duct: When the velocity of air in the duct is more than 600
m/min, the duct is said to be a low velocity duct.


Providing cooling is the most complex part of HVAC systems. The two primary
components used to achieve this are chillers and cooling towers.
• Chillers
• Cooling Towers

21 Chillers
The chiller serves two basic functions: to cool the air in a building and to
provide dehumidification.
Water enters the evaporator and the condenser through external piping. Tubing
inside the piping is surrounded by a chiller medium, which is a compressible
gas such as freon. As the water circulates within the tubing, heat is transferred
between the water and the chiller medium.

The chiller medium is subjected to two stages of pressurization. First, the

medium is fed into the condenser at high pressure by the compressor. When
the medium is compressed, its temperature increases. The chiller medium then
leaves the condenser through an expansion device that suddenly lowers the
medium’s pressure before it enters the evaporator. When the medium is thus
expanded, its temperature decreases. The change in pressurization between
these two stages is the key to the cooling provided by the chiller.
Heat is removed from the air as the air passes over coils in the air ducts
through which chilled water is flowing. This water flows into the evaporator
where the heat is transferred to the chiller medium. The chiller medium is
pressurized in the compressor, then transfers the resultant heat energy, which
is a combination of the building heat picked up in the evaporator and the effects
of compression, into the water in the condenser circuit. The condenser water is
pumped into a cooling tower where the heat delivered from the compressor is
dissipated into the outside air. In effect, the evaporator acts as a device to

absorb heat from the building air while the condenser acts as a device to
remove that heat from the building once it is picked up. Cooling Towers

The job of the cooling tower is to radiate the heat of the building. Located on the
outside of a building, the tower removes heat from the condenser water as the
condenser water removes heat from the chiller. See Figure. Water in a cooling
tower is cooled by evaporation. Every pound of water that a cooling tower
evaporates removes 1,000 BTU from the system. This lowers the temperature
of 1,000 pounds of water by 1 degree Fahrenheit.

The condenser water is released from the top of the tower in a fine spray. The
finer the spray, the more surface area is available for evaporation. As the
cooling tower fans blow air through the spray, the air carries away some of the
heated water vapour, further aiding the evaporation process. Water in the tower
cools by about 10 degrees Fahrenheit and is circulated back to the chiller to be
heated again by the condenser.
The efficiency of evaporation in a cooling tower at any given time is determined
by a combination of outside air temperature and humidity. A special type of
scale, called wet-bulb temperature, was created for controlling cooling towers.
Wet-bulb temperature is determined by a thermometer enclosed in a water-

soaked wick. A tower removes heat better on a cool, dry day than on a hot,
humid day. This reading is therefore used to control most cooling towers.


In order for air and water to be used to control the temperature of a building,
there must be a way to move them around in the building. Pumps and fans are
similar kinetic devices and both use the same principles to move water and air.

• Centrifugal Pumps
• Centrifugal Fans Centrifugal Pumps

A centrifugal pump consists of a rotating impeller inside of a specially shaped
shell. As the impeller rotates, liquid is taken in at the axis of the impeller and
forced out along vanes to its tips. The liquid moves faster at the tips of the
impeller than at the axis. The fluid is then gathered in a specially shaped
diffusing section called a volute, where it is discharged at high pressure.

Pumping systems are designed to increase both the flow and pressure of a
liquid. In tall buildings, the pressure at which water leaves pumps is critical.
Think of a water pipe in a building as a standing column of water. In order to
move the water from the bottom up, the water at the bottom has to be pushed
up with enough force to overcome the weight of the water above and the friction
of the piping system that the water is flowing in. This force is referred to as the
total dynamic head of the system.

All of the water systems in a building must be designed to overcome the

dynamic head of the system and provide the proper flow and pressure at the
water's destination. The water systems in a building include condenser water
pumps, chilled water pumps, HVAC hot water pumps, and domestic water

24 Centrifugal Fans
Traditional, three-bladed, “propeller-style” fans are not very common. They are
often noisy and inefficient. Centrifugal fans are classified according to blade
arrangement such as radial, airfoil, and forward curved. Widely used in larger
HVAC systems, especially in industry, centrifugal fans move considerable
volumes of air over a wide range of pressures.

Centrifugals have a rotating cylinder (impeller) mounted inside a scroll-type

housing which somewhat resembles a snail's shell. These fans have scoop-like
blades that collect air and throw it against the inside of the housing to create the
desired air stream for efficient cooling.

Fan System Design Fans are located in systems according to their intended
functions. Supply fans, for example, bring in air and must be placed so that air
flows through them into the air ducts. Exhaust fans belong at the other end of
the air stream. Fans that supply several spaces at once are centrally located.
Otherwise, flow rates to different spaces vary and the fan operates inefficiently,
wasting energy. In designing systems, engineers must take into account the
temperature of the air that the fan moves. Cool air is denser than hot air. This
affects fan performance and efficiency.

The way that air flows toward a fan is an important factor in determining its
efficiency. If the entire air stream moves at uniform speed, for example, all
portions of the fan do equal work and efficiency is maximized. If air speed is
uneven, the work is unequally distributed, causing a lower operating efficiency.
This problem is often solved by placing a length of straight duct at the fan
intake. The duct smooths the airflow before the air enters the fan. Proper
design of duct work is an art in itself. If this is not done right, the system will
have very poor efficiency and could also have significant audible noise

Air-conditioning fans are usually arranged in long, rectangular ducts. Made from
galvanized steel, the ducts may be attached to the ceilings, walls, or floors of

the conditioned space. Ducts often contain metal vanes that direct the airflow to
increase system efficiency. Room air inlets and outlets are customarily
rectangular in shape and fitted with a metal grill, which often has dampers that
open and close to control flow.


The principal function of control system are:

• To maintain comfortable conditions in the space by providing desired

cooling & heating outputs, while factors which affect the cooling and the
heating outputs vary.

• To maintain comfortable conditions while using least amount of energy.

Controlled Parameters

An HVAC system functions to provide a controlled environment in which

these parameters are maintained with desired ranges:

• Temperature

• Humidity

• Air Distribution

• Indoor Air Quality

In order to accomplish this task, the ATC Control system must be

designed so as to directly control the first three parameters. The fourth
parameter, indoor air quality, is influenced by the first three but may require
separate control methods.

Approaches to Temperature Control

Temperature control in an air conditioning system that uses air as a delivery
medium may use one of the following approaches:

• Vary the temperature of the air supplied to the space while keeping the
air flow rate constant. This is the basic constant volume, variable
temperature approach.

• Vary the air flow rate while keeping the temperature constant for air
supplied to the space. This is variable volume, constant temperature

• Vary the air flow rate and change the temperature for air supplied to the
space. This is variable volume and temperature approach.

• Vary both the supply air temperature an flow rate where the air flow rate
is varied down to minimum value, then energy input to reheat the coil is
controlled to vary the supply air temperature. This is variable volume
reheat approach.

Approaches to Humidity Control

Humidity control in a conditioned space is done by controlling the amount of

water vapor present in the air in the space. When relative humidity at the
desired temperature setpoint is too high, dehumidification is required to reduce
the amount of water vapor in the air for humidity control. Similarly, when relative
humidity at the desired temperature setpoint is too low, humidification is
required to increase the amount of water vapor in the air for humidity control.

Because relative humidity varies significantly with dry bulb temperature, it is

important to state dry bulb temperature and relative humidity together such as
70° F and 50% RH. For example, at a room air conditioned of as 70° F dry bulb
and 50% RH, the moisture content, or specific humidity, is 54.5 grains of water
per pound of dry air. Air with the same specific humidity at 60°F will have about
71% RH and when read at 80°f will have about 36% RH


HVAC system for

Pharmaceutical Plants & Clean Room

2.1 Introduction of Clean Rooms

The concept of clean spaces was first developed for the aerospace electronics
industry. The same concept was appropriately applied to the semi conductor,
pharmaceutical and many other industries where a clean particulate-free
environment is essential for maintaining standards of product quality.
A clean room is a defined area where the critical parameters such as
temperature, humidity, air changes room pressure, particulates variables etc.
are closely controlled to maintain product strength, identity, operator safety and
product quality. This may be a requirement of the law or by virtue of the product
development data. Clean rooms are divided into several classes based on the
particulate concentration limits. The current classification is shown in Fig.1 &

Clean Rooms for Pharmaceutical Application

All pharmaceutical facilities belong to one or other class of clean room.

General acceptance is:
• Tabletting facilities Class M 6.5 (Class 100,000)
• Topical & Oral liquids Class M 5.5 (Class 10,000)
• Injectables Class M 3.5 (Class 100)
Clean rooms are designed for aseptic as well as non-aseptic applications.
Pharmaceutical facilities designed for sterile products will have aseptic clean
rooms while manufacturing of tablets and oral liquids will have non-aseptic
clean rooms. Besides bulk drug plants designed for handling products in
finishing suites will also employ non-aseptic clean rooms.
The entrance to the aseptic clean room should be through a regime of
change rooms generally designated as black grey and a white change rooms in
order of increasing pressures towards the sterile filling facility
Aseptic clean rooms have the following distinct characteristics:
• Highest pressure in the most critical zone is progressively reduced at the
rate of 15 Pa towards the outside. Generally these are of class M5.5 but the
environment within 600mm of the terminal filters will be as good as class
• All Critical operations will be in a laminar flow work station.
• Air handling system is provided with a central HEPA filter bank along with
mandatory terminal filters in order to extend the life of terminal filters.
• Low RH say 35±5% is through chemical dehumidifiers.
• Supply air outlets are provided flush at the ceiling level with perforated
stainless steel grilles and terminal absolute filters
• Return air grilles are provided at the floor level with a return air riser for
better scavenging
• The filtration regime is generally three stages with two stages of pre-filters,
10 micron (EU 4), 3 micron (EU 8) and one central final filter 0.3 micron (EU
12) along with terminal HEPA filter. See Fig.10

2.2 Principle of construction for Pharmaceutical Industry
The emphasis in air conditioning system design in the pharmaceutical industry
lies in providing a clean and aseptic environment with controlled relative
Some of the principles generally followed in the construction and operation in
the pharmaceutical industry are:
• Minimum seams and joints
• Avoid crevices and moldings
• Round off all joints
• All material used is non chipping and cleanable
• Wall and floor finishes should not shed particulates and should provide
self-cleaning surfaces
• Ceilings are to be flush as far as possible
• Provide airlocks & air showers at the entry points of all important areas
• Operations producing particulates are enclosed and exhausted
• Personnel wear lint-free overalls, head covers etc. And do not wear

• Each manufacturer develops over a period of time their own GMP in all
these aspects.

2.3 Design Goals

Room temperature is not critical as long as it provides comfortable

conditions Normal temperatures range between 20 to 25 deg C + 2 deg C,
Relative humidity (RH) on the other hand, is of greater importance in all the
production areas. While most of the areas could have a RH of 50 ± 5% facilities
designed for handling powders need to be at 40 ± 5% Automatic control of the
RH is essential for maintaining continued product quality.
Of all the design goals, it is the quality of air cleanliness of the space and
prevention of contamination which are of utmost importance. All GMP's aim
towards achieving a clean aseptic space suitable for production.

Currently the normally accepted air quality standards are:

• Manufacturing areas:- 20,000 particles of 5 micron or larger per cum of
- 500 per cum of viable organisms
• Large Volume Systems: - 3500 particles of 0.5 micron or larger per cum
of air
- 5 particles of 5 microns or larger per cum - 5 viable organisms
per Cum
The pressure gradients roughly are:

Atmosphere 0 Pa
Change rooms 25 Pa
Non-aseptic areas 25 Pa
Aseptic areas
Cooling corridors 45 Pa
Access corridors 35 Pa
Manufacture laboratory 55 Pa
Filling rooms 55 Pa
Change rooms 25 Pa
(approx. 10 Pa = 1mm wg)

There should be a net airflow from change rooms to the non-aseptic areas even
if the pressures are stated as equal. Regular adjustments are necessary to
compensate for drift and filter clogging
Atmospheric dust is a mixture of dry particles, fibres, mist, smoke, fumes, live or
dead organisms. The air-borne particle size varies from 0.01 micron to as much
as 100 microns. Less than 2.5 micron particles are considered as fine and
particles over 2.5 micron are regarded as coarse. Fine particles are considered
as fine and particles over 2.5 micron are regarded as coarse. Fine particles are
airborne for a longer time and could settle on vertical surfaces. Coarse
particles, products of mechanical abrasion like in grinding and granulation
departments, have lower airborne life time and are subject to gravitational
settlement. The air conditioning systems in the pharmaceutical industry have to
handle both fine and coarse particulates depending on the production pattern
and the filter regime has to be appropriate.
Table 1 is a guide line to filter selection.

Table 1 Air Filter Selection

Areas Efficiency Arrestance Type
Non-aseptic Areas
Pre-filter 1 20-40% dust spot 75 to 85% Panel or bag
Pre-filter 2 80-85 dust spot 98% Panel
Final 95% DOP - Panel
Aseptic Areas
Pre-filter 1 20-40% dust spot 75 to 85% Panel or bag
Pre-filter 2 80-85% dust spot 98% Panel
Final 99.97% DOP - Panel
All filters are dry type with synthetic and glass fiber. While pre-filters could
be cleanable, the final filters are disposable.

Particle Control

Particle sources in a clean room are either external or internal. External

source is atmospheric dust which is a mixture of dry dust particles, fibres, mist,
smoke, fumes, bacteria and live or dead organisms. Entry is largely through

outside make-up air but could also be by infiltration through doors, windows,
wall and ceiling joints and penetrations. Hence a right building with minimum
infiltration will help minimize uncontrolled contamination. Good filtration regime
controls the flow of contaminants through the make-up air.
Internal sources of contamination are personnel, room surface, process
equipment and he process itself. Personnel are by far the largest source of
fenestration of internal particles and are to be controlled through lint-free clean
garments, head wear, entry through air showers and by suitably designed
airflow. Surface shed particulate are to be controlled through proper surface
applications. But, there is no way of predicting the particle generation from
process and the equipment.

2.4 Air Flow Pattern

There are only two basic air flow patterns viz.

• Non-unidirectional and
• Unidirectional employed in a clean room.

Non-unidirectional air flow is clean rooms of class M4.5 and above. In this
airflow pattern, there will be considerable amount of turbulence and it can be
used in rooms where major contamination is from external source that is the
makeup air. The contaminants are filtered out in the air handling unit filters and
also terminal HEPA filters. If internal contaminants are a concern, a clean work
station is provided inside the clean room.

The unidirectional air flow patter is a single pass, single direction air flow of
parallel streams. It is also called 'laminar' airflow although it is not truly laminar
but the parallel streams are maintained within 18 deg - 20 deg deviation. The
velocity of air flow is maintained at 0.46 m/s to 0.65 m/s
Unidirectional air flow clean rooms are vertical down-flow or horizontal
types. Vertical down-flow type has the ceiling of HEPA filters. In class M3.5
rooms the entire ceiling requires to be covered with HEPA filters with low level
returns or solid or perforated floor plenums. The parallelism of streams is
maintainable right up to the working height (say 900mm) but stream lined flow
gets degraded by obstacles by way of people, equipment and work tables. Thus
the room gets divided into an area of stream lined flow and some area of
turbulent flow which causes undesirable particle trajectory Horizontal flow
systems are same as the vertical except that the airflow is horizontal from a wall
of HEPA filters to a receiving wall on the opposite side. In this the parallelism of
stream lines of flow is not as maintainable as in the down flow and further the
space becomes more and more contaminated towards the return wall. Fig.4
shows such a clean room. Between the two, the vertical flow pattern yields
better results and is more adaptable to pharmaceutical production.

2.5 Air Distribution

The air distribution has to be appropriate with the class of clean room.
Class M5.5 and above are generally non-unidirectional with the supply air
outlets at the ceiling level and the return air at the floor level. Class M3.5 and
lower invariably have unidirectional down flow type. Air distribution is designed
so that the aseptic filling room will have a pressure of 50 Pa or above with a
gradient of 15 PA to the adjoining area. The pressure gradients are monitored
with 'U' tube manometers or magnahelic gauges. Alarm and warning systems
may also be provided when the pressure gradients are disturbed.
All duct work must be non-flaking, corrosion resistant and thoroughly
sealed. If any duct extension is provided from the final filter, it should be
minimum in length and should preferably be of stainless steel upto the finishing
suite. Remaining duct work could be of good quality galvanised steel. Round
ducting is a natural choice, being self cleaning in shape, wherever space
permits. All rotating equipments like the fans should be isolated from the rigid
ducting. Ducts should be tested for leaks before the application of insulation.
Volume control dampers must be provided appropriately for easy air balancing.
Wherever possible, provision should be made for cleaning the duct work
internally and externally. Grilles and diffusers should be flush mounted into
ceiling, walls or duct work and all such grilles shall be fabricated from stainless
steel in the clean areas.


Detail of Demonstration Model of

HVAC System

3.1 Details shown in Demonstration Model

We have selected Pharmaceutical Sterile Injectable plant for demonstration of

HVAC System. The Layout of Model is as shown below.
Chiller Unit
Cooling Tower


Plant Model

Air Handling Units

Demonstration Model of HVAC


3.2 The Regular Operation of Pharmaceutical Sterile Injectable plant
shown in demonstration model is:

1. Man & Material Entry passage: - from this passage the Person &
Material can enter to plant with proper Gowning.
2. Change Room for personnel entry to Sterile area (Filling area).
3. Auto Calving Zone:- It is the Non sterile end where we kept the material
in to the Auto Clave for sterilization before entered into the filling Zone.
4. Cooling Zone:-It is the sterile end where we can store the sterilized
material, ready for filling.
5. Filling Zone: Filling Operation performed here.

 The Basic Need of this Plant is :

1. Pure & Conditioned the Air.

2. Manufacturing area having class A, B, C & D as per ISO Standard.
3. Pressure Differential (Air Lock) between adjacent area to avoid

3.3 Details HVAC System shown in Demonstration model

3.3.1 Two Air Handling units installed

 One is for Filling Zone & Change Rooms.

 Second is for Personnel & Material entry & autoclave non
sterile area

Two Air Handling Units Shown

in Model

3.3.2 Ducting for Circulation of air, To & Fro from the rooms to Air
Handling units.

Ducting for Air Circulation

3.3.3 Return Air & Supply Air Grills.

Return Air

3.3.4 Magnehelic gauges to show the differential pressure between

adjacent rooms.
Supply Air
Grills 3.3.5 Cooling Tower for cooling of water for Condenser.

Cooling Tower

Pipe Lines from


Water Strainer

3.3.6 Chiller unit for circulating of chilled water to Air Handling Unit.


Condenser Compressor

Demonstration of Chiller

Pressure Gauge

3.3.7 Air Flow in Demonstration Model

Air In
Cooling & filtration
of Air in AHU



Supply Air

Return Air


HVAC fundamentals: Samuel C.

1 Sugarman
2 ASHRAE Journal Bulletins
3 Refrigeration & Air Conditions R S Khurmi
4 HVAC controls operation & maintenance by Guy W. Gupton
5 Ranbaxy Laboratories’ Ltd, Dewas, for Plant Visit & Idea of
Demonstration Model