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Supplementary Training Modules on

Good Manufacturing Practice


Heating, Ventilation and AirConditioning (HVAC)

Part 1 (b):
Introduction and overview
WHO Technical Report Series,
No. 937, 2006. Annex 2
HVAC

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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

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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

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HVAC
Levels of protection and recommended filtration
Level of
protection

Recommended filtration

Level 1

Primary filters, e.g. EN779 G4*

Level 2 and 3

Production area with 100% outside air: Primary plus


secondary filter (e.g. EN779 G4 plus F8 filters)

Level 2 and 3

Production area with recirculated plus ambient air with a risk


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

HVAC

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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)
HVAC

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4.2.4 4.2.10

HVAC

HVAC

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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

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HVAC
Airflow patterns

HVAC

Turbulent

Unidirectional/laminar

dilution of dirty air

displacement of dirty air

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HVAC
Prefilter

Airflow patterns

AHU

Main filter

HVAC

Turbulent

Unidirectional

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Turbulent

HVAC
Airflow patterns (4)
Workbench (vertical)

HVAC

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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

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HVAC

Annex 5, 7.

HVAC

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HVAC

Annex 5, 7.

HVAC

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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

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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

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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

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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

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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)

HVAC

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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
Operating limits and tolerances
HVAC

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4.5.13 4.5.18,
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

HVAC

Interlocked with air-handling system


No airflow between rooms linked to same system
Room pressure imbalance
4.5.19 4.5.26

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Pressure cascade solids
Protection from cross-contamination
R oom 1

R oom 2

R oom 3

15 Pa

15 Pa

15 Pa

A ir L o c k

A ir L o c k
A ir
30 Pa

Passage

N o te : D i r e c ti o n o f d o o r o p e n i n g r e l a ti v e to r o o m p r e s s u r e
HVAC

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Lock
15 Pa

0 Pa

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

HVAC

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6.2.1 6.2.5