HVAC SYSTEM

QUALIFICATION
Heating Ventilation Air Conditioning System
Prepared By:

Kanishk pandey
Department of Quality Assurance

INTRODUCTION

WHAT IS CLEAN ROOM?

A room in which the concentration of airborne
particle is controlled and which is constructed and
used in a manner to minimize the introduction,
generation and retention of particles inside the
room and in which other relevant parameters.
Important parameters: Temperature,
Relative Humidity
Pressure
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WHY CLEAN ROOM

It controls 3 types of contamination transfer
NECESSARY?
Air borne contamination
Direct contamination by personnel,
equipment etc.
Contamination from fluids like
cleaning fluids, solutions etc.
As airborne particulate are reduced,
chances of particles entry in the process
reduced.
Protects product, personnel & environment.

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INTRODUCTION

HVAC SYSTEMS
Air Handling Units
LAF
DPB(Pass Box)

Ventilation is used to remove

unpleasant smells and excessive

moisture, introduce outside air, to
keep interior building air
circulating, and to prevent
stagnation
of the
air.
Air
conditioning
is theinterior
process of
altering
the properties
of air(primarily temperature and humidity)
to more comfortable conditions.
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AHU

HVAC-play an important role in ensuring the manufacture

of quality pharmaceutical products. A well designed HVAC
system will also provide comfortable conditions for
operators.
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Important terminology
As-Built Condition where the
installation is complete with all services
connected and functioning but with no
production equipment, materials or
personnel present.
At-Rest Condition where the installation
is complete with equipment installed
and operating in a manner agreed
upon by the customer and supplier, but
with no personnel present.
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Important terminology
Relative Humidity- The ratio of the actual
water vapor pressure of the air to the saturated
water vapor pressure of the air at the same
temperature expressed as a percentage. (It is the
ratio of the mass of moisture in the air, relative to the mass
at 100% moisture saturation, at a given temperature)

Turbulent Flow- or non-unidirectional airflow, is

air distribution that is introduced into the
controlled space and then mixes with room air by
means of induction.

Unidirectional Airflow- is a rectified airflow

over the entire cross-sectional area of a clean
zone with a steady velocity and approximately
parallel streamlines
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Basic criteria affects room

Relative humidity
cleanliness
Building finishes

and structure.
equipment
movement
Air filtration
Air change rate or
flushing rate
Room pressure
Location of air
terminals and
directional airflow
Type of product

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Material flow
Personnel flow
Gowning procedures
Process being carried
out (open or closed
system)
Outside air conditions
Occupancy
Cleaning standard
operating procedures
(SOPs).
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INTRODUCTION

Basic Design Of AHU

Plenum

Air In

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HWC

CWC

Motor

Air
Out

Air
Blower

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AHU

HVAC System
Consists of,
1.
2.
3.
4.
5.
6.
7.
8.

AHU plenum/ Cabinet

Dehumidifier / Heater
Filters (Pre & HEPA)
Ducting (For delivery of controlled air)
Supply Fans
Smoke Detector
Dampers (Air, Fire)
Humidity / Temperature / Pressure
sensors
9. Heating / Cooling Coils

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INTRODUCTION
AHU & AFD

Area - 1

10-20%

Fresh Air

Area - 3

I
M
P
U
R
E

Area - 4

A
I
R

Area - 2

Impure Air

HVAC
Pure Air

80-90%
Return
Air

Exhaust 10-20%

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Impure Air

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12

Qualification
Parameter

Qualification Checks

Air Flow Volume (As per Room design )

Filter Integrity (NMT 0.01%)
Air Pressure (As per room Design)
Temp/RH (As per room design)
Non Viable Particle Counts (As per Clean
Room )
Recovery Study
Air Flow Pattern
Microbial Monitoring
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Qualification Matrix
qualification Frequency

S.
No.
1
2

Tests
Measurements of air flow
velocities (air volume) &
calculation of air changes per
hour (Air exchange rates).
HEPA Filter integrity test

Monitoring of temperature &

relative humidity

Pressure Monitoring Test

Non-viable particle monitoring

(Operation)

6
Viable
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count monitoring

Initial

Requalification

One Time

Six monthly

One Time

Six monthly
Once in a year
For 7
for 3
Consecutive
Consecutive
days
days
Once in a year
For 7
for 3
Consecutive
Consecutive
days
days
Once in year,
For
for
7Consecutive
3Consecutive
days
days
Once in year,
For 7
for 3
Consecutive
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Industries
Consecutive
days

Instrument
Required

Anemometer
Photometer
Particle Counter
Thermal Hygrometer
Manometer
Air Sampler

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HVAC/ Clean
Room
Qualification

Air Flow Volume

Equipment :- Anemometer, Capture Hood

Five Point Sampling at filter from 10-15cm

from the surface of filter.
For Grade A laminar flow workstations, the
air flow rates shall be 0.36-0.54 m/s + 20%
The ACPH can be calculated using the following
formula:
Air Volume = Sum ( Avg. Velocity x Filter
ACPH = Air supply volume (m/s) x 3600/ Room
area)
volume (m)
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Air Flow Volume

Anemometer

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HVAC/ Clean
Room
Qualification

HEPA FILTER INTEGRITY

Purpose : To confirm for no leakage
TEST
to filter, seals.
Equipment :
1. Photometer
2. Aerosol generator
DiOctylPhthalate/PAO)

(Using

Scan at 1 inch from filter surface.

Traverse at NMT 10Ft. Min. Cover
entire range.
Make
separate
passes
at
peripheries.
Acceptance:
NMT
0.01%
of

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HEPA FILTER INTEGRITY TEST

Photometer

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Filter Level& grades

EU-4 Filter- retain up to 70-90% of
10.0 particle
EU-6 Filter- retain up to 60-70% of
1.0 particle
EU-9 Filter- retain up to 90% of 10
particle
EU-13 Filter- retain up to 99.99599.997 % of 0.01 particle
EU-14 Filter- retain up to 99.999599.9997 % of 0.001 particle
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HEPA

HEPA-High Efficiency
Particulate Air
Construction- Glass lined
glass Fiber
interception, where
particles following a line of
flow in the air stream come
within one radius of a fiber
and adhere to it.
Impaction, where larger
particles are unable to
avoid fibers by following
the curving contours of the
air stream and are forced
to embed in one of them
directly; this effect
increases with diminishing
fiber separation and higher
air flow velocity.
Diffusion,
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HVAC/ Clean
Room
Qualification

Particle count

Objective:

To Measure the cleanness of the area in terms

of the non viable particulate matter

A should consider for minimum

no. of Location (A-Area of Room)For NVPC
Measured By lassair-III
Selection Shall be consider the
Worst case or maximum chances
of particle contamination
Clean Room Classification
(EUGMP-2011)
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HVAC/ Clean
Room
Qualification
Clean
Area
Class

Grad
e

NVPC Limit

Viable Limit

At Rest

In Operation

0.5

5.0

0.5

5.0

contact plates
CFU/ Hr
55mm
plate

Air
Samplin
g

90mnm
CFU/ M3
plate

100
1000

A
B

3520
3520

20
29

3520
35200

20
290

<1
<5

<1
<5

<1
<10

10,000

35200

290

352000

2900

<25

<50

<100

100,00
0

35200
0

2900

352000
0

29000

<50

<100

<200

Incubation conditions
Incubation of samples, inverted, at
20 - 25C for at least 5 days is
suitable for the growth of mould
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and fungi.

HVAC/ Clean
Room
Qualification

Total Viable Count

(Guideline Values)
Conditions : In operation
Grade
EU
Schedule M
(90mm / 4 Hrs)

A
B
C

<1
<10
<100

(90mm / 2 Hrs)

<1

US

Air Sampling

(90mm / 4 Hrs)

<1
<5

(1000cc)

<1
<3

<50

<7
<5

<10
D

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<200
<100

<100

<50

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HVAC/ Clean
Room
Qualification

Other Tests

Pressure Differential monitoring

Temperature & RH monitoring
Recovery
Air Flow Pattern

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AIR FLOW PATTERNS

NOVA-: Double Deflection
Grille Used for Supply and
Return

Rectangular Fixed
Cones Ceiling Diffuser
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Swirl Ceiling Diffuser Used for

Supply and Return Air with
Adjustable Blades

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Types Of air flow Pattern

As Built (Project Phase)
At Rest
At Operation/Dynamic

As Built

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At Rest

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In Operation

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AIR FLOW PATTERNS

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AIR FLOW PATTERNS

Displaceme
nt

Turbulent
Air

Induction
Diffuser
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Perforated
Diffusion
Swirl

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AIR FLOW PATTERNS

Dispensing
Booth

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Weighing Booth

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Method of air circulation

Cascade method
Sink Method
Bubble Method

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Sink

Bubble

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Bubble Air Lock

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Sink Air Lock

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Bubble Air Lock

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 Differential /RH Monitoring :

Monitor the Pressure and the RH for
consecutive days as per room design
parameter.

Recovery :
"Recovery time" specified as the
timerequired to reduce an (artificially
increased)initial particle concentration
in a cleanroom bya factor of 100.
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