Supplementary Training Modules on

Good Manufacturing Practice

Heating, Ventilation and Air-

Conditioning (HVAC)

Part 2:
HVAC systems and components
Section 7

HVAC | Slide 1 of 29 May 2006

 HVAC

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

HVAC | Slide 2 of 29 May 2006

 HVAC
General
 Design of HVAC is dependent on required
degree of air cleanliness

 Suitable components should be selected

including:
– fans,
– driers,
– filters,
7.
– ducts, grilles, etc.
HVAC | Slide 3 of 29 May 2006
 HVAC Main subsystems

Exhaust air treatment

Fresh air treatment

( make-up air) Terminal air treatment
+
at production room level

Production Room
Central air handling unit

HVAC | Slide 4 of 29 May 2006

 HVAC
Components
Components in HVAC may include, depending on need:
 Filters
 Fans
– no fan failure; including supply air fans, return air
fans, exhaust air fan, dust extract system fans
 Driers
– Drying of air with chemical driers, e.g. rotating
desiccant wheel
 Frost coils for preheating air
7.1.1 – 7.1.7

HVAC | Slide 5 of 29 May 2006

 HVAC
Components
Components in HVAC may include, depending on need:

 Snow eliminators

 Dust eliminators

 Moisture eliminators

 Precooling coils

 Alarm systems, grilles/diffusers, etc. 7.1.1 – 7.1.7

HVAC | Slide 6 of 29 May 2006

 HVAC
Overview components

Exhaust Air Grille

Silencer Flow rate controller Fan Filter

Weather louvre Control damper

+ Heater

Prefilter Humidifier
Terminal filter

Cooling Secondary Production Room

coil Filter
with droplet
Heating
separator
coil
Recirculated air
HVAC | Slide 7 of 29 May 2006
 HVAC

Components (1)

 Weather louvre  To prevent insects, leaves, dirt and

rain from entering
 Silencer‫ خافض الصوت‬ 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

HVAC | Slide 8 of 29 May 2006

 HVAC

Components (2)
 Heating unit  To heat the air to the proper
temperature
 Cooling unit/  To cool the air to the required
dehumidifier 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
predetermined dimensions and/or
 Ducts microorganisms
 To transport the air

HVAC | Slide 9 of 29 May 2006

 HVAC

Air-handling unit

Control damper for airflow

Dry air
Adsorber wheel
Humid room air
AHU with fan
Variable Speed
Regeneration air Controller
Humid room air
Filter
Air heater
Pressure
De-humidification Gauges

HVAC | Slide 10 of 29 May 2006

 HVAC
 Dampers to control pressure differentials are
important. They can be automated or fixed.
 As filters get dirty the system pressure losses
increase, and if airflow is not regulated, the flow
decreases and pressure differentials change.
 This could cause flow reversal and cross-
contamination.
 Variable speed drives for fan motors are also
commonly used to control airflow.

HVAC | Slide 11 of 29 May 2006

 HVAC
 In some cases, it is necessary to have very dry air for
galenical reasons in certain rooms (production of
effervescent tablets and humidity sensitive products in
general).

 To generate dry air, the air supplied to the production is

passed over an adsorbant (silicagel, lithium chloride,
etc.) where the humidity is removed from the air.

 The adsorbant is then re-generated, on a continuous or

on a batch-wise base.

HVAC | Slide 12 of 29 May 2006

 HVAC
Humidifier Silencer Heating and
cooling units

HVAC | Slide 13 of 29 May 2006

 HVAC

Filter classes
Dust filters

Standard Aerosol

Coarse Fine HEPA ULPA

Dp > 10 µ m 10µ 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

HVAC | Slide 14 of 29 May 2006

 HVAC
Primary panel filter

Secondary filter

Secondary filters,
consisting of mini-
pleated media or
filter bags, and is
Primary Panel
used for
filters, which are
higher filtration
used mainly for
efficiency.
lower filtration
or as efficiency
pre-filters

HVAC | Slide 15 of 29 May 2006

 HVAC

HEPA or tertiary filter

HEPA or tertiary filters, usually being

the final filter in the system,
providing the highest filtration
efficiency.

HVAC | Slide 16 of 29 May 2006

 Though there is a strong relationship between filter efficiency
and cleanroom class, a filter of a high efficiency does not
guarantee a high cleanroom class, as many other elements play
a role, such as

• Air flow (how the air is extracted, how well the room is
“flushed)”

• Air speed and number of air changes

• Positions of air terminals

• Layout and presence of objects

• Personnel and clothing

• Equipment (not all machines are designed to operate in a

clean environment!)
HVAC | Slide 17 of 29 May 2006
• Proper installation and proper maintenance
 HVAC

 The table in the next slide gives an idea of the efficiency

of the filters, calculated across the entire surface (integral
value) or in particular spots (local value).

 Referring to filter ratings by percent efficiency is

misleading, as there are so many different types of tests
that give different efficiencies for the same filter. This can
be very confusing and it is better to refer to the
Committee of European Normalisation (EN) test rating i.e.
G4, F8, H12, etc.

HVAC | Slide 18 of 29 May 2006

 HVAC

Classification of filters according to their efficiency

Average Efficiency Peak Arrestance ‫قمة االعتقال‬
‫ قيمة متكاملة‬Integral 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

HVAC | Slide 19 of 29 May 2006

 HVAC

Positioning of filters ( )1

AHU mounted final filter Filter in terminal position

HEPA Filter

Production Room Production Room

HEPA Filter

HVAC | Slide 20 of 29 May 2006

 HVAC
Positioning of filters (2 )
Prefilter

AHU

Main filter
Ceiling
exhausts

1 2 3

Low level exhausts

HVAC | Slide 21 of 29 May 2006

Positioning of filters ( )3
HVAC
This slide shows an HVAC installation feeding two rooms, each one without terminal
filters, but with remote final filters protected by a pre-filter.
Final filter

AHU
Prefilter

1 2

HVAC | Slide 22 of 29 May 2006

 HVAC

3
4

Swirl Type air diffusors with

1 Filter
2 Tightening frame
terminal filters
3 Register outlet
4 Screw fixation for register

HVAC | Slide 23 of 29 May 2006

 Swirl Type air diffusors with terminal filters
 The air flows into the rooms via so-called registers (diffusors), which
are built and installed in such a way that the air is distributed evenly.

 Machinery or furniture can block the passage of air from the register
to the exhaust point, creating unflushed zones, where counts of
particles and micro-organisms could be higher.

 It is therefore important to consider the content of a clean room,

when planning the HVAC system.

 In many cases, the terminal filter panel and diffusors are

incorporated into one unit.

 It is also important that the air diffuser supplies air evenly and does
not induce the circulation of dust in the room – as illustrated by the
next slide.
HVAC | Slide 24 of 29 May 2006
 HVAC

The rising The preferred type

induced air of diffuser for
has the cleanroom
potential for applications is the
carrying a lot swirl diffuser, or
of dust perforated plate
upwards which diffuser. These
is then spread types do not
throughout the High induction Low induction promote the
room with the office type diffusor swirl diffusor spread of dust
air supply. (avoid) (preferred) within the room.

HVAC | Slide 25 of 29 May 2006

 HVAC

Regulation of room pressure – pressure differentials concept

Room pressure
gauges

Room pressure indication panel

HVAC | Slide 26 of 29 May 2006

 HVAC
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

HVAC | Slide 27 of 29 May 2006

 HVAC
In the next slides
Consider different air types, e.g.:
 Supply air
 Return air (recirculated air)
 Fresh air (make-up air)
 Exhaust air

And: Concepts of air delivery to production areas:

 Recirculation systems
 Full fresh-air systems
HVAC | Slide 28 of 29 May 2006
 HVAC

Air types

+ Exhaust
Fresh air ( %15 Supply air
)make-up air air

Production Room
Return air
(recirculated)
about %85 is being re-circulated
HVAC | Slide 29 of 29 May 2006
 HVAC
Recirculation systems

 There should be no risk of contamination and cross-

contamination when air is recirculated

 Normally, HEPA filters (EN1822 H13) needed in supply air

stream
– Not required in single product facility with no risk of cross-
contamination
– Not required where no dust generation (e.g. secondary
packaging)

 HEPA filters placed in AHU or terminally 7.2.1 – 7.2.6

HVAC
Dust| from highlyMaytoxic
Slide 30 of 29 2006 processes should not be recirculated
 HVAC
Ventilation with recirculated air + make-up air

Exhaust Unit

Central Air-Handling Unit

Return air

HVAC | Slide 31 of 29 May 2006

 HVAC

HVAC | Slide 32 of 29 May 2006

 HVAC
Full fresh-air systems
 100% fresh air - normally where toxic products are
processed, and recirculation not recommended

 No contamination from fresh air – sufficient filtration

needed

 Degree of filtration on exhaust dependent on exhaust air

contaminants and environment regulations

 Energy-recovery wheels
– Should not be source of contamination
– Relative pressure between supply and exhaust air 7.3.1 – 7.3.3

HVAC | Slide 33 of 29 May 2006

 HVAC

Ventilation with 100% fresh air (no air recirculation)

Washer (optional)
Exhaust Unit

Central Air-Handling Unit

Production Rooms

HVAC | Slide 34 of 29 May 2006

 HVAC

HVAC | Slide 35 of 29 May 2006