1

Introduction of Clean Room

Reference Guideline

Validation of HVAC

Validation parameter
2

Heating Ventilation and Air Conditioning
System (HVAC)

HVAC systems can have an impact on product quality

It can provide comfortable conditions for operators

Temperature, relative humidity control where appropriate

Supplement to basic GMP
3
Area 1
Area 2
HVAC
Impure air
Pure air
Area 3
Area 4
I
M
P
U
R
E
A
I
R
10% Return
Air
Exhaust
air
4

Testing Procedure ISO 14644-3

Classification based on Non viable particle count - ISO
14644-1
5
Typical parameters to be included in qualification:

Room air change rates/ACPH/Velocity

HEPA filter Integrity/ Leakage test

Non-viable Particle Count

Recovery

Air flow pattern

Room pressures (pressure differentials)

Temperature

Relative humidity

Microbial (Viable count)
6
Test procedure Maximum time Objective
and key aspects interval
Test
Parameter
Velocity
measurement/ACPH
12 months
Verify unidirectional
airflow and or
containment condition
Airflow velocity
HEPA filter Integrity
12 months
Verify air change rates
Airflow volume
Particle count test
Readings and
positions
6 months or 12
Verifies cleanliness
months depending
on Class
Air flow pattern
24 Month
To verify direction of
flow
Area Recovery
24 Month
To evaluate Minimum
time for area to
achieve cleanness
level
Particle count
7
No. of Particle count Location based on area
Sr. No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
Area (in M2 )
NO. of Sampling Points
2
4
6
8
10
24
28
32
36
52
56
64
68
72
76
104
108
116
148
156
192
232
276
352
436
636
1000
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
8
9
10
11
Airlock concept
12
Air flow pattern
Piyush Prajapati, M.Pharm sem-III
(Q.A.)
13
14