air handling unit qualification

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

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Page 1: Air Handling Unit Qualification

Air Handling Systems

Heating Ventilation and Air Conditioning (HVAC)

Part 2: Components

Supplementary Training Modules on GMP

Module 3, Part 2: Components Slide 1 of 20 WHO - EDM

Page 2: Air Handling Unit Qualification

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

Air Handling Systems

Purpose of an air handling system

Air Handling System

Production RoomWith

DefinedRequirements

SupplyAir

OutletAir

Page 3: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 3 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

Page 4: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 4 of 20 WHO - EDM

Air Handling Systems

+

Production Room

Exhaust air treatment

Central air handling unit

Terminal air treatmentat production room level

Fresh air treatment (make-up air)

Main subsystems

Page 5: Air Handling Unit Qualification

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

Air Handling Systems

FilterSilencer

Terminal filter

Weather louvre Control damper

FanFlow rate controller

Humidifier

Heating coil

Cooling coil with droplet

separator

Production Room

Overview components

+

Prefilter

Exhaust Air Grille

Heater

Secondary Filter

Re-circulated air

Page 6: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 6 of 20 WHO - EDM

Air Handling Systems

Weather louvre

Silencer

Flow rate controller

Control damper

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

Components (1)

Page 7: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 7 of 20 WHO - EDM

Air Handling Systems

Heating unit Cooling unit /dehumidifier

Humidifier

Filters

Ducts

To heat the air to the proper temperature

To cool the air to the required temperature or to remove moisture from the air

To bring the air to the proper humidity, if too low

To eliminate particles of pre-determined dimensions and/or micro-organisms

To transport the air

Components (2)

Page 8: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 8 of 20 WHO - EDM

Air Handling Systems

Flow rate controller

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 insulatorleaking

Problems with components

Page 9: Air Handling Unit Qualification

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

Air Handling Systems

+

Production Room

Exhaust air

Return air(re-circulated)

Fresh air(make-up air)

Supply air

Air types

Page 10: Air Handling Unit Qualification

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

Air Handling Systems

Particles / m3

? 0.5µm

US 209Dnon-

metric

US 209E1992

metric

EC cGMPAnnex I1997

GermanyVDI 20831990

UKBS 52951989

J apanJ IS B 9920

1989

ISO 14644-1

13,5 0 2 210 M 135 1 M 1.5 1 3 3

100 M 2353 10 M 2.5 2 4 4

1.000 M 33.530 100 M 3.5 A, B

A= unidirectionalB= turbulent

3 E or F 5 5

10.000 M 435.300 1.000 M 4.5 4 G or H 6 6

100.000 M 5353.000 10.000 M 5.5 C 5 J 7 7

1.000.000 M 63.530.000 100.000 M 6.5 D 6 K 8 8

10.000.000 M 7

Comparing International Cleanroom Classifications

Page 11: Air Handling Unit Qualification

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

Air Handling Systems

Filter classesDust filters

Standard Aerosol

FineCoarse ULPAHEPA

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

F5 - F9G1 - G4 U 14- 17H 11 - 13

EN 1822 StandardEN 779 Standard

Page 12: Air Handling Unit Qualification

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

Air Handling Systems

Average EfficiencyIntegral Value

Peak ArrestanceLocal Value

Retention in%

Penetration Efficiency Penetration

F9 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

Classification of filters according to their efficiency

Page 13: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 13 of 20 WHO - EDM

Air Handling Systems

Primary panel filter

Secondary filter

HEPA or tertiaary filter

Page 14: Air Handling Unit Qualification

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

Air Handling Systems Humidifier Silencer Heating and cooling units

Page 15: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 15 of 20 WHO - EDM

Air Handling Systems

Control damper for air flow

De-humidification

Filter Pressure Gauges

AHU with fan Variable Speed Controller

Humid room air

Air heater

Regeneration air

Humid room airAdsorber wheel Dry air

Air handling unit

Page 16: Air Handling Unit Qualification

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

Air Handling Systems

Swirl Type air diffusors with terminal filters1 Filter

2 Tightening frame3 Register outlet4 Screw fixation for register

1

2

3

4

Page 17: Air Handling Unit Qualification

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

Air Handling Systems

Low induction swirl diffusor(preferred)

High induction office type diffusor

(avoid)

Page 18: Air Handling Unit Qualification

Module 3, Part 2: Components Slide 18 of 20 WHO - EDM

Air Handling Systems

Annex 1, 17.26

Regulation of room pressure – pressure differentials concept

Room pressure gauges

Room pressure indication panel

Page 19: Air Handling Unit Qualification

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

Air Handling SystemsPressure cascade injectables

Protection from micro-organisms and particles

Note : Direction of door opening relative to room pressure

15 Pa

0 PaAirLock

30 Pa PassageD

C

A

B

D LF

Air LockAir Lock45 Pa

Room 3 Room 2 Room 1

45 Pa60 Pa30 Pa

Annex 1, 17.24, 17.25

Page 20: Air Handling Unit Qualification

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

Air Handling Systems

Pressure cascade solidsProtection from cross-contamination

Note : Direction of door opening relative to room pressure15 Pa15 Pa15 PaE30 PaPassage0 PaAirLock Room 3 Room 2 Room 115 PaAir LockAir Lock

Note : Direction of door opening relative to room pressure

15 Pa

15 Pa15 Pa

E30 Pa

Passage0 Pa

AirLock

Room 3 Room 2 Room 1

15 Pa

Air LockAir Lock