HVAC - Heating, Ventilation and Air - Conditioning

Supplementary Training Modules on
Good Manufacturing Practice
Heating, Ventilation and Air-

Conditioning (HVAC)
Part 1 (b):
Introduction and overview
WHO Technical Report Series,
No. 937, 2006. Annex 2
HVAC | Slide 1 of 31 May 2006

HVAC
Objectives
To continue from Part 1(a), now focus on:
 Air filtration
 The role of HVAC in dust control
 HVAC system design and its components (part 2)
 Commissioning, qualification and maintenance (part 3)

HVAC
Air Filtration
 Degree of filtration is important to prevent contamination
 Type of filters to be used dependent on the quality of ambient

air, return air and air change rates
 Manufacturer to determine, select and prove appropriate filters

for use considering level of ambient air contamination, national
requirements, product specific requirements
4.2.1, 4.2.3

HVAC
Levels of protection and recommended filtration

Recommended filtration Level of
protection
Primary filters, e.g. EN779 G4* Level 1
Production area with 100% outside air: Primary plus Level 2 and 3
secondary filter (e.g. EN779 G4 plus F8 filters)
Production area with recirculated plus ambient air with a risk Level 2 and 3
of cross-contamination: Primary plus secondary plus tertiary
filter (e.g. EN779 G4 plus F8 plus EN1822 H13 filters)
*Filter class should be referenced to the standard test method 4.2.1

HVAC
Contamination should be prevented through
appropriate:
 Materials for components and construction
 Design and appropriate access to dampers, filters and other
components
 Personnel operations
 Airflow direction
 Air distribution component design and installation and location
 Type of diffusers (non-induction type recommended)
 Air exhaust (normally from a low level) 4.2.4 – 4.2.10

HVAC

HVAC
Airflow patterns
Filtered air entering a production room or covering a
process can be
 turbulent, or
 unidirectional (laminar)
 GMP aspect
 economical aspect
Other technologies: barrier technology/isolator technology.

HVAC
Airflow patterns
Turbulent Unidirectional/laminar
dilution of dirty air displacement of dirty air

HVAC
Airflow patterns Prefilter
AHU
Main filter
1 2 3
Turbulent Unidirectional Turbulent

HVAC
Airflow patterns (4)

Workbench (vertical) Cabin/booth Ceiling

HVAC
Unidirectional airflow (UDAF):
Provided where needed over product or material to prevent
contamination, or to protect operator
UDAF in weighing areas

 The aim is to provide dust containment
 Airflow velocity should not affect balance
 Position of material, balance, operator determined and
validated – no obstruction of airflow or risk
4.3.1 – 4.3.10

HVAC
Annex 5, 7.

HVAC
Annex 5, 7.

HVAC
Infiltration
 Facilities normally under positive pressure to the

outside
 Prevent infiltration of unfiltered, contaminated air

from outside
 Some cases - negative pressure (e.g. penicillin

manufacture). Special precautions to be taken
4.4.1 – 4.4.4

HVAC
Cross-contamination
 General aspects and concepts
 Displacement concept
– low pressure differential, high airflow
 Pressure differential concept

– high pressure differential, low airflow
 Physical barrier concept

4.5

HVAC
General aspects
 Multiproduct OSD manufacturing, prevent movement of

dust between areas where different products are
processed
 Directional air movement and pressure cascade can be

helpful – dust containment
 Normally, corridor at higher pressure than cubicles,

cubicles at higher pressure than atmosphere
4.5.1 – 4.5.3

HVAC
Containment concepts
 Pressure cascade regime influenced by:

– Product and product group, e.g. highly potent products (in
some cases, pressure cascade regime negative to
atmosphere)
– Processing methods
 Building structure should be considered including airtight

ceilings and walls, close fitting doors, sealed light fittings
4.5.4 – 4.5.9

HVAC
Displacement concept
 Air supplied to the corridor, through the doors (grilles) to

the cubicles
 Air extracted at the back of the cubicle
 Velocity high enough to prevent turbulence in doorway
 Requires large air quantities
(Not preferred method)

4.5.10 – 4.5.12

HVAC
Pressure differential concept
 Concept can include high pressure differential, low airflow, and
airlocks in the design
 Airlock types include: Cascade, sink and bubble type
 Sufficient pressure differential required to ensure containment

and prevent flow reversal – but not so high as to create
turbulence
 Consider effect of other items such as equipment and

extraction systems in cubicles
4.5.13 – 4.5.18,
 Operating limits and tolerances 4.5.22

HVAC
Pressure differential concept (2)
 Calibrated monitoring devices, set to alarm system
 Monitoring and recording of results
 Doors open to higher pressure
 Dust extraction system design

– Interlocked with air-handling system
– No airflow between rooms linked to same system
– Room pressure imbalance 4.5.19 – 4.5.26

HVAC
Pressure cascade solids
Protection from cross-contamination
Room 1 Room 2 Room 3
15 Pa 15 Pa 15 Pa
A ir L o c k A ir L o c k
A ir
Lock
30 Pa E 0 Pa
Passage
15 Pa
N o te : D ir e c tio n o f d o o r o p e n in g r e la tiv e to r o o m p r e s su r e

HVAC
Physical barrier concept
 In some cases, impervious barriers are used to

prevent cross-contamination
 Spot ventilation
 Capture hoods
4.5.27 – 4.5.28

HVAC
Temperature and relative humidity (RH)
 Controlled, monitored and recorded where relevant
 Materials and product requirements, operator comfort
 Minimum and maximum limits
 Premises design appropriate, e.g. low humidity areas,

well sealed and airlocks where necessary
 HVAC design – also prevent moisture migration

4.6.1. – 4.6.6

HVAC
Temperature and relative humidity (RH) (2)
 Remove moisture, or add moisture as necessary
 Dehumidification
– Refrigerated dehumidifiers with cooling media
– Chemical dehumidifiers
 Humidifiers should not be sources of contamination
– Use of pure steam or clean steam
– No chemicals added to boiler system if these can have a
detrimental effect on product (e.g. some corrosion
inhibitors/chelating agents)
4.6.7. – 4.6.11

HVAC
Temperature and relative humidity (RH) (3)
Humidification systems: Design should be such that the system
does not become the source of contamination:
 No accumulation of condensate
 Avoid evaporative systems, atomizers, water-mist sprays
 Suitable duct material, insulation of cold surfaces
 Air filters not immediately downstream of humidifiers
 Chemical driers – used if not sources of contamination
4.6.12. – 4.6.18

HVAC
Dust Control
 Dust and vapour removed at source
 Point of use extraction – fixed points or movable hood –

plus general directional airflow in room
 Ensure sufficient transfer velocity to prevent dust settling

in ducting
 Risk analysis – airflow direction, hazards, operator

5.1. – 5.7

HVAC
Dust Control (2)
 Normally air supplied through ceiling diffusers, and air
extracted from low level – aids flushing effect
 Extraction of vapours – consider density of vapour
 Handling harmful products – additional steps needed

– e.g. barrier technology, glove boxes
– totally enclosed garments with air-breathing systems
 Fresh air rate supply

– comfort, odour and fume removal, leakage, pressure control, etc.
5.8. – 5.14

HVAC
Protection of the environment (Exhaust air dust)
 Exhaust air from equipment and some areas of production
carry heavy loads of dust (e.g. FBD, coating, weighing)
 Filtration needed to prevent ambient contamination
 Not highly potent material
– EN779 F9 filter recommended
 Harmful substances (e.g. hormones)
– EN1822 H12 (HEPA) filter recommended
– In some cases two banks of HEPA filters
– Safe change filter housings ("bag-in bag-out" filters)
6.1.1 – 6.1.5

HVAC
Protection of the environment (Exhaust air dust) (2)
 Filter banks provided with pressure differential indication

gauges
 Limits indicated, results monitored at regular intervals

– Manual, Building Management Systems, Building
Automated Systems, System Control and Data Acquisition
systems
 Automated systems provided with alarm or similar system

to indicate OOS
6.1.6 – 6.1.10

HVAC
Protection of the environment (Exhaust air dust) (3)
 Reverse pulse dust collectors
– Should be equipped with cartridge filters with compressed air
lance,
– Continuous operation – no interruption of airflow
 Dust collectors with mechanical shakers

– Used in a manner not to become source of contamination
– Switched off at times resulting in loss of airflow, and disruption of
pressure cascade
 Wet scrubbers
– Use suitable drainage system for dust slurry 6.1.11 – 6.1.15
 Determine exhaust air quality to verify filtration efficiency

HVAC
Protection of the environment (Fume removal)
 Appropriate design, installation, and operation of fume,
dust, effluent control
 Wet scrubbers
– Added chemicals for increased adsorption efficiency
 Deep bed scrubbers
– Activated carbon or chemical adsorption granular media
– Specific to type of effluent
– Type and volume prepared
6.2.1 – 6.2.5

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Supplementary Training Modules on

Good Manufacturing Practice

Heating, Ventilation and Air-

HVAC | Slide 1 of 31 May 2006

 The role of HVAC in dust control

 HVAC system design and its components (part 2)

 Commissioning, qualification and maintenance (part 3)

HVAC | Slide 2 of 31 May 2006

 Type of filters to be used dependent on the quality of ambient

 Manufacturer to determine, select and prove appropriate filters

HVAC | Slide 3 of 31 May 2006

Levels of protection and recommended filtration

*Filter class should be referenced to the standard test method 4.2.1

HVAC | Slide 4 of 31 May 2006

HVAC | Slide 5 of 31 May 2006

HVAC | Slide 6 of 31 May 2006

Other technologies: barrier technology/isolator technology.

HVAC | Slide 7 of 31 May 2006

HVAC | Slide 8 of 31 May 2006

Airflow patterns Prefilter

Turbulent Unidirectional Turbulent

HVAC | Slide 9 of 31 May 2006

Airflow patterns (4)

HVAC | Slide 10 of 31 May 2006

UDAF in weighing areas

HVAC | Slide 11 of 31 May 2006

HVAC | Slide 12 of 31 May 2006

HVAC | Slide 13 of 31 May 2006

 Facilities normally under positive pressure to the

 Prevent infiltration of unfiltered, contaminated air

 Some cases - negative pressure (e.g. penicillin

HVAC | Slide 14 of 31 May 2006

 General aspects and concepts

 Pressure differential concept

 Physical barrier concept

HVAC | Slide 15 of 31 May 2006

 Multiproduct OSD manufacturing, prevent movement of

 Directional air movement and pressure cascade can be

 Normally, corridor at higher pressure than cubicles,

HVAC | Slide 16 of 31 May 2006

 Pressure cascade regime influenced by:

 Building structure should be considered including airtight

HVAC | Slide 17 of 31 May 2006

 Air supplied to the corridor, through the doors (grilles) to

 Air extracted at the back of the cubicle

 Velocity high enough to prevent turbulence in doorway

 Requires large air quantities

(Not preferred method)

HVAC | Slide 18 of 31 May 2006

 Airlock types include: Cascade, sink and bubble type

 Sufficient pressure differential required to ensure containment

 Consider effect of other items such as equipment and

HVAC | Slide 19 of 31 May 2006

 Calibrated monitoring devices, set to alarm system

 Monitoring and recording of results

 Doors open to higher pressure

 Dust extraction system design

HVAC | Slide 20 of 31 May 2006

Room 1 Room 2 Room 3

HVAC | Slide 21 of 31 May 2006

 In some cases, impervious barriers are used to

HVAC | Slide 22 of 31 May 2006

 Controlled, monitored and recorded where relevant