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Modules on GMP
Air Handling Systems
Heating
Ventilation and
Air Conditioning (HVAC)
Part 2: Components
Slide 1 of 20
WHO - EDM
Air Handling
System
Supply
Air
Production Room
With
Defined
Requirements
Slide 2 of 20
Outlet
Air
WHO - EDM
2.
3.
Slide 3 of 20
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Production Room
Central air handling unit
Slide 4 of 20
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Silencer
Weather louvre
Fan
Control damper
Filter
Heater
+
Humidifier
Prefilter
Heating
coil
Cooling coil
with droplet
separator
Terminal filter
Secondary Filter
Production Room
Re-circulated air
Slide 5 of 20
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Weather louvre
Silencer
Flow rate
controller
Control damper
Automated adjustment of
volume of air (night and day,
pressure control)
Fixed adjustment of volume of air
Slide 6 of 20
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Heating unit
Cooling
unit
/dehumidifier
Humidifier
Filters
Ducts
Slide 7 of 20
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Control damper
Humidifier
Cooling battery
Filters
Ducts
Blocked
Poorly adjusted, bad pressure differential system
Bad water/steam quality/poor drainage
No elimination of condensed water/poor
drainage
Incorrect retention rate/damaged/badly installed
Inappropriate material/internal insulator
leaking
Slide 8 of 20
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Fresh air
(make-up air)
Supply
air
Exhaust
air
Production Room
Return air
(re-circulated)
Slide 9 of 20
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0.5m
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
E or F
G or H
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
Slide 10 of 20
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Dust filters
Standard
Aerosol
Coarse
Fine
HEPA
Dp > 10 m
10 m > Dp > 1 m
G1 - G4
F5 - F9
Dp < 1 m
H 11 - 13
EN 779 Standard
ULPA
U 14- 17
EN 1822 Standard
Slide 11 of 20
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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
Peak Arrestance
Local Value
Efficiency Penetration
Slide 12 of 20
WHO - EDM
Secondary filter
Module 3, Part 2: Components
Slide 13 of 20
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Silencer
and
cooling units
Slide 14 of 20
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Heating
Adsorber wheel
Regeneration air
Dry air
Air heater
De-humidification
WHO - EDM
3
4
1 Filter
Swirl
2 Tightening frame
3 Register outlet
4 Screw fixation for
register
WHO - EDM
High induction
office type diffusor
(avoid)
Module 3, Part 2: Components
Slide 17 of 20
Low induction
swirl diffusor
(preferred)
WHO - EDM
Room pressure
gauges
Room pressure indication panel
Annex 1, 17.26
Module 3, Part 2: Components
Slide 18 of 20
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R oom 1
R oom 2
30 Pa
60 Pa
R oom 3
45 Pa
A
LF
D
A ir L o c k
45 Pa
A ir L o c k
B
15 Pa
30 Pa
Passage
A ir
Lock
0 Pa
Slide 19 of 20
WHO - EDM
R oom 2
R oom 3
15 Pa
15 Pa
15 Pa
A ir L o c k
A ir L o c k
A ir
30 Pa
Passage
Lock
0 Pa
15 Pa
N o te : D i r e c ti o n o f d o o r o p e n i n g r e l a ti v e to r o o m p r e s s u r e
Slide 20 of 20
WHO - EDM