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 WHO - EDM

 Air Handling Systems

Purpose of an air handling system

Air Handling
System

Production Room
Supply With Outlet
Air Defined Air
Requirements

Module 3, Part 2: Components Slide 2 of 20 WHO - EDM

 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 WHO - EDM

 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 WHO - EDM

 Air Handling Systems
Overview components
Exhaust Air Grille Flow rate controller
Silencer Fan Filter

Weather louvre Control damper

Heater
+
Humidifier
Prefilter Terminal filter

Cooling coil Secondary Filter

Production Room
with droplet
separator
Heating
coil Re-circulated air

Module 3, Part 2: Components Slide 5 of 20 WHO - EDM

 Air Handling Systems
Components (1)
 Weather louvre
 Silencer
 Flow rate controller
 Control damper
Module 3, Part 2: Components
To prevent insects, leaves, dirt and
rain from entering
To reduce noise caused by air
circulation
Automated adjustment of volume of
air (night and day, pressure control)
Fixed adjustment of volume of air
Slide 6 of 20 WHO - EDM
 Air Handling Systems
Components (2)
 Heating unit To heat the air to the proper temperature

 Cooling unit To cool the air to the required temperature

/dehumidifier 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 WHO - EDM

 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 WHO - EDM

 Air Handling Systems
Air types

+ Exhaust
Fresh air Supply air
(make-up air) air

Production Room
Return air
(re-circulated)

Module 3, Part 2: Components Slide 9 of 20 WHO - EDM

 Air Handling Systems
Comparing International Cleanroom Classifications
Particles / m3 US 209D US 209E EC cGMP Germany UK Japan ISO 14644-
 0.5µm non- 1992 Annex I VDI 2083 BS 5295 JIS B 9920 1
metric metric 1997 1990 1989 1989
1
3,5 0 2 2
10 M1
35 1 M 1.5 1 3 3
100 M2
353 10 M 2.5 2 4 4
1.000 M3
3.530 100 M 3.5 A, B 3 E or F 5 5
A= unidirectional
B= turbulent
10.000 M4
35.300 1.000 M 4.5 4 G or H 6 6
100.000 M5
353.000 10.000 M 5.5 C 5 J 7 7
1.000.000 M6
3.530.000 100.000 M 6.5 D 6 K 8 8
10.000.000 M7

Module 3, Part 2: Components Slide 10 of 20 WHO - EDM

 Air Handling Systems
Filter classes Dust filters

Standard Aerosol

Coarse Fine HEPA ULPA

Dp > 10 µ m 10 µ m > Dp > 1 µ m Dp < 1 µ m

G1 - G4 F5 - F9 H 11 - 13 U 14- 17

EN 779 Standard EN 1822 Standard

Module 3, Part 2: Components Slide 11 of 20 WHO - EDM

 Air Handling Systems

Classification of filters according to their efficiency

Average Efficiency Peak Arrestance
Integral Value Local Value
Retention in Penetration Efficiency Penetration
%
F9 85 0.15

H11 95 0.05
-3 -3
H12 99.5 5x10 97.5 25x10
-4 -4
H13 99.95 5x10 99.75 25x10
-5 -5
U14 99.995 5x10 99.975 25x10

Module 3, Part 2: Components Slide 12 of 20 WHO - EDM

 Air Handling Systems

HEPA or tertiaary filter

Primary panel filter

Secondary filter
Module 3, Part 2: Components Slide 13 of 20 WHO - EDM
 Air Handling Systems
Humidifier Silencer Heating and
cooling units

Module 3, Part 2: Components Slide 14 of 20 WHO - EDM

 Air Handling Systems

Control damper for air flow

Adsorber wheel Dry air

Humid room air AHU with fan Variable
Speed Controller

Regeneration air Humid room air

Filter Pressure
Air heater Gauges

Air handling unit

De-humidification
Module 3, Part 2: Components Slide 15 of 20 WHO - EDM
 Air Handling Systems

1
2

3
4

1
2
Filter
Tightening frame
Swirl Type air diffusors with
3 Register outlet terminal filters
4 Screw fixation for register

Module 3, Part 2: Components Slide 16 of 20 WHO - EDM

 Air Handling Systems

High induction Low induction

office type diffusor swirl diffusor
(avoid) (preferred)

Module 3, Part 2: Components Slide 17 of 20 WHO - EDM

 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 WHO - EDM

 Air Handling Systems
Pressure cascade injectables
Protection from micro-organisms and particles

Room 1 Room 2 Room 3

30 Pa 60 Pa A 45 Pa

LF
D

Air Lock Air Lock

45 Pa B C

15 Pa

Air
30 Pa D Passage 0 Pa
Lock

Annex 1, 17.24, 17.25

Note : Direction of door opening relative to room pressure

Module 3, Part 2: Components Slide 19 of 20 WHO - EDM

 Air Handling Systems
Pressure cascade solids
Protection from cross-contamination

Room 1 Room 2 Room 3

15 Pa 15 Pa 15 Pa

Air Lock Air Lock

Air
Lock
30 Pa E 0 Pa

Passage
15 Pa

Note : Direction of door opening relative to room pressure

Module 3, Part 2: Components Slide 20 of 20 WHO - EDM