HEATING

VENTILATION &
AIRCONDITIONING
 HELLO!
I am Avishek Sensarma
I am here to give a presentations on HVAC.
You can find me at [email protected]

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CONTENT

▰ Introduction of HVAC
▰ History of HVAC
▰ Application of HVAC
▰ Component of HVAC
▰ Clean Area /Room
▰ Classification of Clean Area
▰ Airlocks
▰ Qualification of HVAC system 3
1
INTRODUCTION

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H= Heating
V= Ventilation
AC= Air Conditioning
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 INTRODUCTION OF HVAC

▰ HVAC refers to Systems which are mechanical arrangements

that treats outside air to produce cleaned (from dust and
microbes) conditioned air ( temperature and humidity) which is
circulated or re-circulated for use in controlled and critical areas
within the pharmaceutical manufacturing space
OR
▰ Can be simply said to be a utility system used to provide air
ventilation, heating, cooling and air conditioning services to a
building or a pharmaceutical space for drug manufacturing
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2
HISTORY

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The first comfort HVAC
system was installed in
New York Stock
Exchange in the Year
of 1902 8
 FATHER OF HVAC SYETEM

Willis Haviland Carrier (November 26, 1876 –

October 7, 1950) was an American engineer,
best known for inventing modern air
conditioning . Carrier invented the first
.electrical air conditioning unit in 1902 and, in
1915, he founded Carrier Corporation , a
company specializing in the manufacture and
distribution of heating, ventilation, and air
conditioning (HVAC) systems.

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3
APPLICATION

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 HOTELS

SHOPPING MALL

HOSPITALS
185,244 users
PHARMA INDUSTRIES

TELECOM INDUSTRIES
100%
IT INDUSTRIES 11
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COMPONENTS

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 COMPONENTS OF HVAC

The HVAC system is mainly consists of Air Handling Units (AHU).

HVAC is the central unit to which AHU is connected.

Components of AHUs are as follows :

 Weather louvre
 Silencer
 Flow rate controller
 Control damper
 Fan/Blower
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 COMPONENTS OF HVAC

Components of AHUs are as follows :

 Heating Unit
 Cooling Unit/ Dehumidifier
 Humidifier
 Filters
 Ducts

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 OVERVIEW COMPONENTS

Silencer Flow rate controller Fan Filter

Weather louvre
Control damper

+
Prefilter Humidifier
Terminal filter

Cooling coil Production Room

with droplet
separator

Heating
coil 15
INSIDE THE AIR HANDLING UNIT

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SCHEMATIC DIAGRAM OF AHU

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 AHU CIRCULATION TYPE

100% FRESH AIR TYPE RECIRCULATION TYPE

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 WEATHER LOUVRE

To prevent insects,
leaves, dirt and rain from
entering

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 SILENCER

To reduce noise caused

by Air Circulation.

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 FAN /BLOWER

To suck the fresh air from

the atmosphere or from
the production room.
Fan blower is run by a
powerful motor.

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 FLOW RATE CONTROLLER

▰Automated adjustment of
volume of air (night and
day, pressure control)

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 CONTROL DUMPER

▰Fixed adjustment of volume of

air

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 HEATING UNIT

▰To heat the air to the

proper temperature

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 COOLING UNIT /DEHUMIDIFIER

▰To cool the air to the

required temperature or to
remove moisture from the
air

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 HUMIDIFIER

▰To bring the air to the

proper humidity, if too low

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 DUCTS

▰To transport the air

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 FILTERS

▰To eliminate particles of

pre-determined
dimensions and/or micro-
organisms

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FILTERS TYPES

DUST FILTER

STANDARD AEROSOL

COARSE FINE HEPA ULPA

G1-G4 F5-F9 H11-H13 U14-U17

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GRADE WISE FILTER EFFICENCY

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GRADE WISE FILTER EFFICENCY

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5
CLEAN AREA/ROOM

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 NASA's Goddard
Space Flight Center
is Worlds Largest
Clean Room

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 WHAT IS CLEAN ROOM

l A room/area in which the concentration of airborne particles is

controlled.

l A room/area, which is constructed and used in a manner to

minimize the introduction, generation and retention of particles
inside the room.

l A room/area in which other relevant parameters e.g.

Temperature, Humidity and Pressure are controlled as
necessary.
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 WHY CLEAN ROOM

l To avoid cross contamination.

l To avoid physical contamination like Air borne Foreign particles

and fibers.

l To avoid microbial contamination.

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CLEAN ROOM CLASSIFICATION AS PER ISO

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CLEAN ROOM CLASSIFICATION AS PER EU

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CLEAN ROOM CLASSIFICATION AS PER USFDA

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6
AIRLOCKS

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 WHAT IS AIRLOCK

Airlock is a small room with controlled air flow acting as barrier

between spaces, minimises volume of contaminated air that is
introduced into the cleaner area when door is opened.

▰ Air lock should open and close fast( minimise time of

contamination
▰ No simultaneous opening of booth doors
▰ High air change rate and smaller airlock ensure faster recovery
time

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 TYPES OF AIRLOCK

Airlock are mainly four types

• Bubble type
• Cascade type
• Sink type
• Dual Compartment Airlock

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7
HVAC QUALIFICATION

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HVAC QUALIFICATION

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QUALICATION FLOW CHART
QUALIFICATION ACTIVITY FLOW

Design Installation Operation Performance

Qualification Qualification Qualification Qualification

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 DESIGN QUALIFICATION

Design Qualification includes

•System description.
•Basic Design Concept
•Methodology
•Acceptance Criteria
•Summary & Conclusion

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 INSTALLATION QUALIFICATION

Installation Qualification includes

• Equipment specification & Identification
• Major component Verification
• Levelling and Alignment
• Verification of Installation & Verification of Utilities
• Check List for Duct Network
• Drawings & Documents
• SOP Verification 48
 OPERATION QUALIFICATION

Operation Qualification includes

• Instrument Calibration
• Key Functionality
• Operational Checks
• Safety Features
• SOP verification
• PM planner verification.
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 PERFORMANCE QUALIFICATION

Performance Qualification includes (Cont..)

• Pressure Drop across the HEPA and Fine filters of Air Handling Unit
• Air Velocity Measurement and Calculation of Air Changes
• Integrity test of HEPA filters
• Differential Pressure Test
• Temperature and Relative Humidity Test

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 PERFORMANCE QUALIFICATION

Performance Qualification includes (cont..)

• Air Flow Direction Test

• Cleanliness Class Verification (Non viable Particle Count)
• Sound level Test
• Light Level Test
• Air Borne Viable Particle Monitoring
• Recovery test
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 REQUALIFICATION

Scheduled Qualification
Scheduled qualifications as per validation plan shall be carried out.
Unscheduled Qualification shall be carried out incase of ;

• Substitution of existing HVAC system with a new system.

• Replacement of existing HEPA-Filter or critical component.
• Any major modification to the existing HVAC system since purchase
or after the last performance qualification.
• Frequent surpassing of the alert or action limits of routine
environmental monitoring parameters 52
PERFORMANCE
QUALIFICATION
TESTS

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 PRESSURE DROP ACROSS THE HEPA AND
FINE FILTERS OF AIR HANDLING UNIT

Objective:
The purpose of this test is to check the Clogged or clean condition of the
across filters of the Air Handling Unit.
Test Equipment:
Differential pressure Transmitter or Manometer
Procedure for HEPA, Fine and Pre Filters:
Ensure that the differential pressure transmitter is connected to before the
filter and after the filter. Check the status of the filter whether the filter is in
clean condition or Clogged condition.
Acceptance Criteria: 54
HEPA, Pre and Fine filters should be in clean condition
 AIR VELOCITY MEASUREMENT AND
CALCULATION OF AIR CHANGES

Objective:
To demonstrate that the air system is balanced and capable of delivering air
velocities and providing number of air changes per hour in the respective
rooms as per requirement.

Test Equipment:
Digital Anemometer / Vane Anemometer

Procedure:
For compliance of air change rate, velocity to be measured at 5 different
locations 2” below the each Terminal HEPA Filter or Grill (Four Corners and
center) with the help of calibrated Anemometer. 55
 AIR VELOCITY MEASUREMENT AND
CALCULATION OF AIR CHANGES

Calculate the average velocity of the air coming from Supply Grill / Terminal
Filter.

Calculate the total airflow from all the Supply Grill / Terminal Filter in the room
and add values to get the total airflow in the room (CFM).

Acceptance Criteria:
Average velocity and subsequent airflow through supply terminals should
meet the design criteria of air change rate as per requirement

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 INTEGRITY (LEAK) TEST OF HEPA FILTER

Objective:
To check the installation integrity of the HEPA Filter in Air Handling Units.

Test Equipment:
Aerosol generator
Aerosol Photometer, duly calibrated with national /
international traceability.
DOP Liquid (Di Octyl Phthalate) /
PAO (Poly Alpha Olefin) Liquid

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 INTEGRITY (LEAK) TEST OF HEPA FILTER

Procedure:
Position the Aerosol generator and introduce Aerosol into the upstream air,
ahead of the HEPA filters, at the concentration of 80-100 g per liter of air at
the filter’s designed airflow rating and set the instrument at 100%
concentration. Scan the downstream side of the filter with an appropriate
photometer probe at a sampling rate of at least 1 ft3 / min.

Acceptance Criteria:
During scanning percentage of the PAO/ DOP Liquid penetration shown by
photometer should be less than 0.01% through the filter media and should be
‘zero’ through mounting joints for 99.97 efficiency HEPA Filters and 0.001%
for 99.997 Efficiency. 58
 DIFFERENTIAL PRESSURE TEST

Objective:
To demonstrate the capability of air system and to provide pressure gradient
among different rooms.

Equipment Used:
Differential Pressure Display Unit or BMS System/Magnehelic Gauges .

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 DIFFERENTIAL PRESSURE TEST

Procedure:
To avoid unexpected changes in air pressure and to establish a baseline, all
doors in the facility must be closed and no man movement to be allowed
during the observations. Observe the differential pressure through Display
Unit or BMS System / Magnehelic Gauges .

Acceptance Criteria:
Pressure differentials should meet the requirement as specified in system
specification.

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 TEMPERATURE & RELATIVE HUMIDITY TEST

Objective:
To demonstrate the ability of the HVAC system to provide temperature and
Relative Humidity within the specified range.

Test Equipment:
Temperature and Relative Humidity Sensor
Display Unit for Temperature and Relative Humidity

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 TEMPERATURE & RELATIVE HUMIDITY TEST

Procedure:
Observe the temperature and relative humidity through respective display
unit wherever installed. Use Hygrometer to check the reading of Temperature
and RH in other rooms.
Temperature and RH in the area to be checked and recorded in Static as well
as Dynamic Condition.

Acceptance Criteria:
Temperature and relative humidity should meet the requirement as specified
in system specification.

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 AIR FLOW DIRECTION TEST

Objective
To ensure that the HFC system in aseptic area, LAF and Pass box provide
unidirectional airflow up to the working height during rest and operating
condition.
To demonstrate that the air pressure is balanced and air is flowing from high-
pressure zone to low pressure zone.

Procedure
Place a torch of Dry Ice / TiCl4 under HFC.
Observe the flow of Dry Ice / TiCl4 smoke at the filter downstream.
Videotape the smoke flow pattern.
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 AIR FLOW DIRECTION TEST

Acceptance Criteria

Under HFC, Smoke Flow should be unidirectional up to working height

Smoke should flow from the higher-pressure zone to low-pressure zone
between the rooms when the door is open.

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 CLEANLINESS CLASS VERIFICATION (NON
VIABLE PARTICLE COUNT)

Objective:
To verify that the clean rooms are having cleanliness class as
specified in specification sheet.
Test Equipment:
Air borne particulate counter of 1 CFM suction capacity, duly
calibrated with traceability to national / international standard.
Procedure:
Particulate counting shall be carried out at predefined locations.
Particulate Count shall be taken in 3 rounds of Static condition
and 3 rounds of Dynamic condition.
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 CLEANLINESS CLASS VERIFICATION (NON
VIABLE PARTICLE COUNT)

Static Condition:
In static condition all the machines shall be kept switched ‘OFF’. Only
restricted man movement shall take place.
Dynamic Condition:
In dynamic condition the operator shall mock desired operation and
restricted man movement shall take place.
Acceptance Criteria:
Clean room or clean zone shall meet the acceptance criteria for an air
borne particulate as referred in standard ISO 14644-1.

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 AIR BORNE VIABLE PARTICLE MONITORING

Objective:
To determine the air borne microbial contamination level in critical
area.
Air borne microbial count by settling plate exposure method:
Pre incubated SCDA Media plates shall be exposed in Locations
mentioned for 4 hours and incubated for 48 hours at 30°C to 35°C
followed by next 72 hours at 20°C to 25°C.Record the results in
respective format. PDA plates shall be exposed weekly to monitor
the fungal counts. SCDA plates shall be incubated once in fifteen
days to monitor the anaerobic Microorganisms
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 AIR BORNE VIABLE PARTICLE MONITORING

Air borne microbial count by Active Air Sampling:

To check the Viable Air borne particle count active air
sampling is done and incubate the tested Cassettes for 48
hours at 30°C to 35°C and further for 72 hours at 20°C to
25°C and observations are recorded in the respective format.

Acceptance Criteria:
All the Parameters performed in the area should meet the
following requirements

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 SOUND LEVEL TEST

Objective:
To verify that the sound level is in limit in the clean room area.

Test Equipment:
Sound Level Meter, duly calibrated with traceability to national /
international standard.
Procedure:
Take the reading at 5 locations in the room and take the average
of the sound in the unit of decibels.
Acceptance Criteria:
The clean room or clean zone shall meet the acceptance criteria 69
for sound level as mentioned below.
 LIGHT LEVEL TEST

Objective:
To verify that the Light level is in limit in clean room area.
Test Equipment:
Lux Meter, duly calibrated with traceability to national / international
standard.
Procedure:
Take the reading at 5 locations in the room and take the average of the
light level in the unit of Lux.
Acceptance Criteria:
The clean room or clean zone shall meet the acceptance criteria for light 70
 RECOVERY TEST

Objective:
To establish the recovery time frame for the area to attain the required
conditions after the simulation of particle counts from class A & class B.

Test Equipment:
Non-viable particle counter dually calibrated.

Procedure:
Simulate and ensure to a count equivalent to that of grade C areas at rest
by the following methods as below:
 Personnel Movement.
 Garments dusting. 71
 RECOVERY TEST

Operate the Air borne non – viable particulate counter in the Class A & B
areas and continuously operate the non viable particulate counter and
note down the time taken after restoration as equivalent to class A & B.

Acceptance Criteria:
During restoration the particle count limits should fall in the class limits (as
referred in standard ISO 14644-1).

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 Any questions?
You can find me at
@8336055587 & [email protected]
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REFERENCES

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