Supplementary Training Modules on

Good Manufacturing Practice

Heating,
Ventilation and Air-
Conditioning
(HVAC)

Part 3:
HVAC systems and
components
 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 Main subsystems

Exhaust air treatment

Fresh air treatment

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

Production Room
Central air handling unit
 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
 General
• Pharmaceutical products should be manufactured in areas of
appropriate cleanliness
• Prevent contamination and cross-contamination
• Design of HVAC dependent on various factors e.g.
• Outside air quality
• Recirculation of air (or not)
• Products and range of products
• Risk assessment to determine clean room conditions.
 General
• Two basic concepts of air delivery
–a re-circulation system, and
–a full fresh air system (100% outside air supply).
• Recirculation – determine the amount of fresh air based on
criteria:
–to compensate for leakage and loss
–to comply with national building regulations; and
–for odour control.
 General
• Validated automated monitoring systems (e.g. Building management
systems (BMS), building automation system (BAS) or system control and
data acquisition (SCADA) system) - capable of indicating any out-of-
specification condition without delay e.g. by means of an alarm
– Also helps with preventive maintenance and trend logging
– Critical alarms easily identifiable, visible and/or audible
• Fan interlock failure matrix
• Fan failures can cause a system imbalance, resulting in a pressure
cascade malfunction with a resultant airflow reversal.
 Air distribution
• Positioning of supply and extract grilles to provide effective room
flushing.
• Low-level return or exhaust air grilles preferred.
• If not possible, a higher air change rate may be needed to achieve a
specified clean area condition, e.g. where ceiling return air grilles are
used.
• There may be alternative locations for return air

7.2.1 – 7.2.2
 HVAC

Air types

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

Production Room
Return air
(recirculated)
 Recirculation systems
• Increased risk of contamination and cross-contamination.
• Need HEPA filters (EN1822 classification of H13)
• HEPA filters may not be required:
– a single product facility and there is evidence that cross-contamination would not be
possible.
– No dust generated e.g. secondary packing
• HEPA filters installed in the air-handling unit or terminally placed
– If terminally mounted - not with flexible ducting
• If highly toxic processes – never recirculate
 HVAC
Ventilation with recirculated air + make-up air

Exhaust Unit

Central Air-Handling Unit

Return air
 Full fresh-air systems
• 100% fresh air normally used in a facility dealing with toxic products or
solvents, where recirculation of air with contaminants should be avoided
• Degree of filtration of the exhaust air depends on the exhaust air
contaminants and local environmental regulations
• HEPA filters in the exhaust system normally when handling hazardous
materials
 HVAC

Ventilation with 100% fresh air (no air recirculation)

Washer (optional)
Exhaust Unit

Central Air-Handling Unit

Production Rooms
 Energy-recovery wheels
• Risk assessment to determine cross-contamination risks
• Should not become a source of possible contamination
• Alternatives include crossover plate heat exchangers and water-coil heat
exchangers
• Prevent air leakage between the supply air and exhaust air
– exhaust air system operates at a lower pressure than the supply system.
 Components
Components in HVAC may include, depending on need:
• frost coils to preheat the air
• reheaters for humidity control, moisture eliminators
• automatic air volume control devices
• sound attenuators
• snow eliminators, dust eliminators,
• fresh air precooling coils
 HVAC
Overview components
Exhaust Air Grille
Silencer Flow rate controller Fan Filter

Weather louvre Control damper

Heater
+
Humidifier
Prefilter Terminal filter

Cooling coil Production Room

with droplet Secondary Filter
separator
Heating
coil
Recirculated air
 HVAC

Components (1)

• Weather louvre • To prevent insects, leaves, dirt and rain from

entering
• Silencer • To reduce noise caused by air circulation
• Automated adjustment of volume of air
• Flow rate controller (night and day, pressure control)
• Fixed adjustment of volume of air
• Control damper
 HVAC

Components (2)
• Heating unit • To heat the air to the proper temperature
• To cool the air to the required
• Cooling unit/ temperature or to remove moisture from
dehumidifier the air
• To bring the air to the proper humidity, if
• Humidifier too low
• To eliminate particles of predetermined
• Filters dimensions and/or microorganisms
• To transport the air
• Ducts
 HVAC

Air-handling unit

Adsorber wheel Dry air

Humid room air
AHU with fan Variable
Speed Controller

Regeneration air Humid room air

Filter Pressure
Air heater Gauges
De-humidification
HVAC
 HVAC

HEPA or tertiary filter

Primary panel filter

Secondary filter
 HVAC

3
4

1 Filter
2 Tightening frame
3 Register outlet
4 Screw fixation for register
 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
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Call: (719) 576-7158