Components on GMP Air Handling Systems

1.

Supplementary Training Modules
on GMP
Air Handling Systems
Heating
Ventilation and
Air Conditioning (HVAC)
Part 2: Components
Module 3, Part 2: Components
Slide 1 of 20
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2.

Air Handling Systems
Purpose of an air handling system
Air Handling
System
Supply
Air
Module 3, Part 2: Components
Production Room
With
Defined
Requirements
Slide 2 of 20
Outlet
Air
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3.

Air Handling Systems
Objectives
In the following slides, we will study the components of air
handling systems in order to:
1.
become familiar with the components
2.
know their functions
3.
become aware of possible problems
Module 3, Part 2: Components
Slide 3 of 20
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4.

Air Handling Systems
Main subsystems
Exhaust air treatment
Fresh air treatment
(make-up air)
+
Terminal air treatment
at production room level
Production Room
Central air handling unit
Module 3, Part 2: Components
Slide 4 of 20
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5.

Air Handling Systems
Overview components
Exhaust Air Grille
Silencer
Weather louvre
Flow rate controller
Fan
Filter
Control damper
Heater
+
Humidifier
Prefilter
Heating
coil
Cooling coil
with droplet
separator
Module 3, Part 2: Components
Terminal filter
Secondary Filter
Production Room
Re-circulated air
Slide 5 of 20
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6.

Air Handling Systems
Components (1)
Weather louvre
To prevent insects, leaves, dirt and
rain from entering
Silencer
To reduce noise caused by air
circulation
Flow rate controller
Automated adjustment of volume of
air (night and day, pressure control)
Control damper
Fixed adjustment of volume of air
Module 3, Part 2: Components
Slide 6 of 20
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7.

Air Handling Systems
Components (2)
Heating unit
To heat the air to the proper temperature
Cooling unit
/dehumidifier
To cool the air to the required temperature
or to remove moisture from the air
Humidifier
To bring the air to the proper humidity, if
too low
Filters
To eliminate particles of pre-determined
dimensions and/or micro-organisms
Ducts
To transport the air
Module 3, Part 2: Components
Slide 7 of 20
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8.

Air Handling Systems
Problems with components
Flow rate controller
Blocked
Control damper
Poorly adjusted, bad pressure differential system
Humidifier
Bad water/steam quality/poor drainage
Cooling battery
No elimination of condensed water/poor drainage
Filters
Incorrect retention rate/damaged/badly installed
Ducts
Inappropriate material/internal insulator
leaking
Module 3, Part 2: Components
Slide 8 of 20
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9.

Air Handling Systems
Air types
Fresh air
(make-up air)
Supply
air
Exhaust
air
+
Production Room
Return air
(re-circulated)
Module 3, Part 2: Components
Slide 9 of 20
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10. Comparing International Cleanroom Classifications

Air Handling Systems
Comparing International Cleanroom Classifications
Particles / m
3
0.5µm
1
3,5
10
35
100
353
1.000
3.530
US 209D
nonmetric
1
10
100
US 209E
1992
metric
M1
M 1.5
M2
M 2.5
M3
M 3.5
EC cGMP
Annex I
1997
A, B
Germany
VDI 2083
1990
UK
BS 5295
1989
Japan
ISO 14644JIS B 9920
1
1989
0
2
2
1
3
3
2
4
4
3
E or F
5
5
4
G or H
6
6
C
5
J
7
7
D
6
K
8
8
A= unidirectional
B= turbulent
10.000
35.300
100.000
353.000
1.000.000
3.530.000
10.000.000
1.000
10.000
100.000
M4
M 4.5
M5
M 5.5
M6
M 6.5
M7
Module 3, Part 2: Components
Slide 10 of 20
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11. Filter classes

Air Handling Systems
Filter classes
Dust filters
Standard
Aerosol
Coarse
Fine
HEPA
Dp > 10 µ m
10 µ m > Dp > 1 µ m
G1 - G4
F5 - F9
Dp < 1 µ m
H 11 - 13
EN 779 Standard
Module 3, Part 2: Components
ULPA
U 14- 17
EN 1822 Standard
Slide 11 of 20
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12.

Air Handling Systems
Classification of filters according to their efficiency
F9
Average Efficiency
Integral Value
Retention in Penetration
%
85
0.15
H11
95
0.05
H12
99.5
5x10
-3
97.5
25x10
-3
H13
99.95
5x10
-4
99.75
25x10
-4
U14
99.995
5x10
-5
99.975
25x10
-5
Module 3, Part 2: Components
Peak Arrestance
Local Value
Efficiency Penetration
Slide 12 of 20
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13.

Air Handling Systems
HEPA or tertiaary filter
Primary panel filter
Secondary filter
Module 3, Part 2: Components
Slide 13 of 20
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14. Humidifier Silencer Heating and cooling units

Air Handling Systems
Humidifier
Module 3, Part 2: Components
Silencer
Slide 14 of 20
Heating and
cooling units
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15. Control damper for air flow

Air Handling Systems
Control damper for air flow
Humid room air
Adsorber wheel
Regeneration air
Dry air
AHU with fan Variable
Speed Controller
Humid room air
Filter Pressure
Gauges
Air heater
De-humidification
Module 3, Part 2: Components
Air handling unit
Slide 15 of 20
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16. Swirl Type air diffusors with terminal filters

Air Handling Systems
1
2
3
4
1
2
3
4
Filter
Swirl
Tightening frame
Register outlet
Screw fixation for register
Module 3, Part 2: Components
Type air diffusors with
terminal filters
Slide 16 of 20
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17.

Air Handling Systems
High induction
office type diffusor
(avoid)
Module 3, Part 2: Components
Low induction
swirl diffusor
(preferred)
Slide 17 of 20
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18. Regulation of room pressure – pressure differentials concept

Air Handling Systems
Regulation of room pressure – pressure differentials concept
Room pressure
gauges
Room pressure indication panel
Annex 1, 17.26
Module 3, Part 2: Components
Slide 18 of 20
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19. Pressure cascade injectables Protection from micro-organisms and particles

Air Handling Systems
Pressure cascade injectables
Protection from micro-organisms and particles
Room 1
Room 2
30 Pa
60 Pa
Room 3
45 Pa
A
LF
D
Air Lock
45 Pa
Air Lock
B
C
15 Pa
30 Pa
D
Passage
Air
Lock
0 Pa
Annex 1, 17.24, 17.25
Note : Direction of door opening relative to room pressure
Module 3, Part 2: Components
Slide 19 of 20
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20.

Air Handling Systems
Pressure cascade solids
Protection from cross-contamination
Room 1
Room 2
15 Pa
Room 3
15 Pa
Air Lock
15 Pa
Air Lock
Air
Lock
30 Pa
E
Passage
0 Pa
15 Pa
Note : Direction of door opening relative to room pressure
Module 3, Part 2: Components
Slide 20 of 20
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