Important of clean room and hvac system

IMPORTANCE OF CLEAN ROOM AND
DESCRIBE TO HVAC SYSTEM IN
PHARMACEUTICAL INDUSTRIES
PRESENTED BY;
RONAK PRAJAPATI
M.SC PHARMACEUTICAL(1ST
SEM.)
MADHAV UNIVERSITY

CONTENT
• What is clean room.
• Types of clean room.
• Principal of the clean environment.
• Types of contamination.
• Contamination sources.
• Contamination control.
• Classes of contamination.
• Gowning .
• Air handling system.
• Entry & exit.
• Test & frequency.

WHAT IS CLEAN ROOM?
• ‘Federal standard 209E’ define a clean room as a room in which the
contamination of airborn partical is controlled to specified limit.
• ‘British standard’ define a clean room as a room with control a partical
contamination constructed and use in such a way as to minimize the
introduction , generation and retention of partical inside the room and
in which the temperature, humidity, airflow, patterns, air motion, and
pressure are controlled.

TYPES OF CLEAN ROOM.
• Turbulentry ventilated / non unidirectional flow clean room.
• 1. Turbulentry ventilated- receving clean filtred air throught air diffuser in the
ceiling this air mixed in the room air and remove air born contamination through
air extract at the bottom of the wall. In this style of the clean room the
contamination is generated by people and the machines is mixed and diluted with
the supply air and them removed.
• 2. Non Unidirectional flow clean room- Hepa(high epiciency particulate air)
filters are installed across a whole celling ( or whole in system ) & these supply air .
This air sweeps up across the room in a unidirectional only way at a speed of
around 0.4m/s (80ft/min) & exists throught the floor these removing the air born
contamination from the room.

PRINCIPAL OF THE CLEAN ENVIRONMENT
• Air is highly (HEPA) filtered
(99.97%@ 0.3 µm)
• Lay out should minimize partical
sources in filtered air stream .
• Air flow should remove most
partical generated by process.

TYPES OF CONTAMINATION.
• Particulate. ( dust , skin, hair,
make up )
• Chemical ( oil, grease, metal ion,
perfume )
• Biological ( bacteria , fungi ,
rodents )
• Radiation ( ultraviolet light )

CONTAMINATION SOURCES
• People ~ 75%
• Ventilation ~ 15%
• Room structure ~ 5%
• Equipment ~ 5%

CONTAMINATION CONTROL
• Personal control.
• Dress code.
• Personal hygiene.
• Gowning.
•Environment control.
• Entrance and exit.
• Materials and supplies.
• Cleaning and maintenance.
• Atmospheric ( HVAC & microbial
monitoring )

CLASSES OF CONTAMINATION
Federal standard 209E
Gone from the new standards are Class 1, Class 10 and all the other familiar classifications of 209E.
The new names are ISO Class N where N is a numerical number between 1 and 9, in increments of
0.1. As with 209, the class name tells the maximum allowed number of particles of a given diameter.
In the ISO classifications, however, the maximum allowable concentration for a given class is 10 N ,
the concentration units are particles per cubic meter, and the reference particle diameter is 0.1 micron
and larger -- quite different from 209E in which the Class number is itself the maximum allowable
concentration of particles per cubic foot with a reference particle diameter of 0.5 micron. With the
available filtration technology, 0.5-micron particles are not a significant problem anymore.

FS209E TABLE 1 : AIRBORNE PARTICULATE CLEANLINESS
CLASSES
Metric ` Imperial 0.1µm 0.2µm 0.3µm 0.5µm 5µm
M Class M3/FT3 m3/ft3 m3/ft3 M3/ft3 M3/ft3
1 350/9.91 75.7/2.14 30.9/0.875 10/0.283
1.5 1 1240/35.0 265/7.5 106/3.00 35.3/1.00
2 3500/99.1 757/21.4 309/8.75 100/2.83
2.5 10 12400/350 2650/75.0 1060/30 353/10
3 35000/991 7570/214 3090/87.5 1000/28.3
3.5 100 26500/750 10600/300 3530/100
4 75700/2140 30900/875 10000/283 247/7.00
4.5 1000 35300/1000 618/17.5
5 100000/2830 2470/70
5.5 10000 353000/10000 6180/175
6 1000000/28300 24700/700
6.5 100000 3530000/100000 61800/1750
7 10000000/283000

ISO 14644-1 TABLE 1-SELECTED AIRBORNE PARTICULATE CLEANLINESS
CLASSES FOR CLEANROOM AND CLEAN ZONES
Metric 0.1µm 0.2µm 0.3µm 0.5µm 0.1µm 5µm
Iso class m3 m3 m3 m3 m3 m3
1 10 2
2 100 24 10 4
3 1000 237 102 35 8
4 10000 2370 1020 352 83 29
5 100000 23700 10200 3520 832 293
6 1000000 237000 102000 35200 8320 2930
7 352000 83200 29300
8 3520000 832000 293000
9 35200000 8320000 2930000

COMPARISON BETWEEN 209E TO ISO 14644-1
CLASSIFICATIONS
Iso 14644-1 Fed std
209E
Iso class English metric
1
2
3 1 M1.5
4 10 M2.5
5 100 M3.5
6 1000 M4.5
7 10000 M5.5
8 100000 M6.5
9
• Cleanliness classification
levels defined by FS209E
and ISO 14644-1 are
approximately equal, except
the ISO standard offers new
class designations, a metric
measure of air volume and
adds three additional classes
- two cleaner than Class 10
and one beyond than Class
100,000.

GOWNING
• Proper gowning order.
• Hair covered.
• Hood.
• Shoe cover.
• Coverall.
• Gloves.
• Face mask.
• Safety glasses.
• Cotton garments shed fiber, hence not used

AIR HANDLING SYSTEM
• Requirement .
• Temperature should be 15-25ºc.
• At least 20 air change should be there per hour.
• Cleanliness requirement i.e. class 100.
• Relative humidity 45-55%.

ENTRY & EXIT
• Enter and exit quickly.
• Only one person may enter at one time.
• Each user must use their own access card.
• Pass from the gowning area to the clean area slowly to reduce migration of partical
between areas.

TEST & FREQUENCY
Test frequency
• Piratical monitoring in air – 6 month
• Hepa filter integrity testing- year
• Air change rate calculation- 6 month
• Air pressure differentials- daily
• Temperature and humidity- daily
• Microbiological monitoring by- daily

ENVIRONMENT CONTROL SYSTEM
•HVAC SYSTEM
• Air filtration.
• Pressurization.
• Temperature.
• Humidity.
• Air born.
• Cleanliness.

HVAC SYSTEM
• Purpose- The provide a specific set of environment condition required for the manufacturing
process.
• Function-
• Heating and cooling.
• Humidifying and dehumidifying.
• Cleaning the air.
• Regulate air flow.
• Pressurization.
• Uses-
• To prevent contamination.
• To provide comfortable working condition.

HVAC TYPES
• Heating-heating is the significant in
maintaining adequate room temperature specially
during cold weather.
• Ventilation- process of “changing ‘ of
replacing air in any space to control temperature
of remove any combination.
• Air conditioning- air conditioning and
refrigeration are provide through the removal of
heat.

HVAC
• HVAC - heating ventilation and air conditioning system.
• The hvac system regulates.
• Room temperature.
• Humidity.
• Air quality.
• Air flow.

HVAC COMPONENT
• Air conditioning.
• AHU’S.
• Dehumidifiers/ heater
• Filter ( pre.& HEPA ).
• Dust extractor.
• Ducting ( for delivery of controlled air )
• Supply fan.
• Smoke detectors.
• Damper.
• Humidity / temp. / pressure sensor.
• Heating and cooling coils

ENVIRONMENTAL MONITORING
Schedule-M
• Particulate monitoring in air - monthly
daily
• HEPA filter integrity testing - yearly
• Air change rate - monthly
• Temperature and humidity - Daily
• Air pressure differentials - daily
• Microbiological monitoring - daily( in aseptic
area )

AIR- C0NDITIONING
• An air conditioner designed
to change the air
temperature and humidity
within an area (used for
cooling and sometimes
heating depending on the
air properties at a given
time). The cooling is
typically done using a
simple refrigeration cycle,
but sometimes evaporation
is use.

AHU’S
• The air handling unit is an equipment consisting of fans, heating and cooling coils, air-control
dampers, filters .
• It collect and mix outdoor air with that returning from the building space.
• The air mixture is then cooled or heated, after which it is discharged into the building space
through a duct

DEHUMIDIFIERS/ HEATER
• •In dehumidifier evaporator and
condenser coils are placed in the
same air path, and the entire
unit is placed in the environment
.
• • Having the condenser coil in
the same air path as the
evaporator coil produces warm,
dehumidified air
• •The air next passes over the
condenser coil, re-warming the
now dehumidified air.

FILTER ( PRE. & HEPA )
• A particulate air filter is a device composed
of fibrous materials which removes solid
particulates such as dust, pollen grains,
mold, and bacteria from the air.
• A chemical air filter consists of an
absorbent or catalyst for the removal of
airborne molecular contaminants such as
volatile organic compounds or ozone.
• Air filters are used in applications where
air quality is important.

DUST EXTRACTOR
• A dust collection system is
an air quality
improvement system.
• Dust collection systems
work on the basic formula
of capture, convey and
collect.

DUCTING (FOR DELIVERY OF CONTROLLED AIR)
• •Ducts are used to deliver and remove
air.
• •A duct system is often called as
ductwork.
• Materials
1. Polyurethane and Phenolic insulation
panels (pre-insulated air ducts)
1. Fiberglass duct board (preinsulated
nonmetallic ductwork
1. Flexible Ducting

SUPPLY FANS
• Flow rate controlled
by inlet vanes or
outlet dampers on the
fan.
• The supply fan speed
is controlled to
maintain pressure in
the supply duct

SMOKE DETECTORS
• •A smoke detector is a
device that detects
smoke, typically as an
indicator of fire.
Commercial,
industrial, and mass
residential devices
issue a signal to a fire
alarm system.

DAMPER
• A plate or gate placed in a
duct to control air flow by
increasing friction in the
duct.
• Smoke damper-
A damper or adjustable
louver designed to augment
the ventilation of a space
during a fire

HUMIDITY/TEMP./ PRESSURE SENSORS
• This function board is used
to measure humidity.
• Temperature sensors are
devices used to measure the
temperature.
• A pressure sensor measures
pressure, typically of gases
or liquids.

HEATING & COOLING COILS
• A heating coil is a piece of equipment built for
efficient heat transfer from one medium to another.
• A cooling coil cools air blown across it and into the
building occupied space.

WHAT CAN HVAC DO?
• Control airborne particles, dust and micro-organisms
• Maintain room pressure (delta P)
• Maintain space moisture (Relative Humidity)
• Maintain space temperature

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

TYPES OF CLEAN ROOM
. Horizontal Clean Room – Horizontal Laminar flow
(HEPA filters in a wall force clean air from one side of the room to
other.)
• Vertical Clean Room – Vertical Laminar flow
(HEPA filters on the ceiling push clean air down to the
floor.)

FOUR BASIC PRINCIPLES OF CLEAN ROOM
• Not To Bring Any Dust
• Not To Accumulate Any Dust
• Not To Generate Any Dust
• To Remove Any Dust Quickly

VALIDATION OF AHU/HVAC SYSTEM
• Temperature control test
• Humidity control test
• Filter integrity test
• Air velocity test
• Air flow pattern(Smoke test)
• Microbiological test.

TEMPERATURE CONTROL TEST
• Objective:- To demonstrate the ability of the HVAC system to control
temperature.
• Equipment- Thermometer.
• Test procedure: Environment is divided by a grid Size of square- 60cm
60cm or more Sampling location- work height Result compare with specification.
• Acceptance criteria:- Temp. 20 2ºC

HUMIDITY CONTROL TEST
• Objective:- To demonstrate the ability of the HVAC system to control humidity.
• Equipment- Automatic humidity recorder.
• Test procedure- Environment is divided by a grid .
• Size of square- 60cm 60cm or more.
• Sampling location- work height .
• Result compare with specification.
• Acceptance criteria:- Humidity: 45 5%

FILTER INTEGRITY TEST
• Objective:- To provide evidence of the integrity of the HEPA filter.
• Acceptance criteria-
99.97 efficiency- 0.03% particles of 0.3 µm 99.99 efficiency- 0.01% particles of 0.3 µm.

AIR FLOW VELOCITY AND UNIFORMITY TEST:
• Test procedure-
• Environment is divided by grid
• Measure by Airflow meter
• Acceptance criteria:
Vertical flows - 0.30 m/sec 20%
Horizontal flows - 0.45 m/sec 20%
• Action: - Deviation indicates blockage of filter
• Solution :- Alteration of fan speed HEPA filter replacement

AIR FLOW SYSTEM( SMOKE TEST )
• Test procedure:- (smoke test)
• Generate visible smoke upstream from the work zone.
• Establish the reference point.
• Videotape the direction of the flow in both case.
• Determine the direction.

MICROBIOLOGICAL TESTS
• Solid growth media-
1. Sampling conditions -
• Sampling in the at rest condition may be continued at an agreed frequency to monitor baseline
contamination levels.
• The operational conditions and the activities being performed at the time of testing should be recorded.
2. Incubation conditions -
• Incubation of samples, inverted, at 20 – 25C for at least 5 days is suitable for the growth of mold
and fungi.
• Incubation of samples, inverted, at 30 - 35C for at least 2 days is suitable for the growth of bacteria

APPLICATION OF HVAC
• 1. Health-Care Facilities Residences
• 2. Educational Facilities
• 3. Laboratories
• 4. Pharmaceutical Industries
• 5. Non Pharmaceutical Industries
• 6. Tall Buildings
• 7. Hotels
• 8. Places of Assembly
• 9. Nuclear Facilities
• 10. Commercial and Public Buildings

CONCLUSION
• HVAC is “ heart ‘ of Pharmaceutical Industries that purify the
outside air and circulate all over the areas.
• HVAC system provide specific set of environment condition
which required to make quality product so therefore it must be
validated

Important of clean room and hvac system

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Important of clean room and hvac system