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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
Slide 2 of 31
May 2006
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
Slide 3 of 31
May 2006
HVAC
Levels of protection and recommended filtration
Level of
protection
Recommended filtration
Level 1
Level 2 and 3
Level 2 and 3
HVAC
Slide 4 of 31
May 2006
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
Slide 5 of 31
May 2006
4.2.4 4.2.10
HVAC
HVAC
Slide 6 of 31
May 2006
HVAC
Airflow patterns
Filtered air entering a production room or covering a
process can be
turbulent, or
unidirectional (laminar)
GMP aspect
economical aspect
HVAC
Slide 7 of 31
May 2006
HVAC
Airflow patterns
HVAC
Turbulent
Unidirectional/laminar
Slide 8 of 31
May 2006
HVAC
Prefilter
Airflow patterns
AHU
Main filter
HVAC
Turbulent
Unidirectional
Slide 9 of 31
May 2006
Turbulent
HVAC
Airflow patterns (4)
Workbench (vertical)
HVAC
Slide 10 of 31
May 2006
Cabin/booth
Ceiling
HVAC
Unidirectional airflow (UDAF):
Provided where needed over product or material to prevent
contamination, or to protect operator
HVAC
Slide 11 of 31
May 2006
HVAC
Annex 5, 7.
HVAC
Slide 12 of 31
May 2006
HVAC
Annex 5, 7.
HVAC
Slide 13 of 31
May 2006
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
Slide 14 of 31
May 2006
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
Slide 15 of 31
May 2006
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
Slide 16 of 31
May 2006
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
HVAC
Slide 17 of 31
May 2006
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)
HVAC
Slide 18 of 31
May 2006
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
Slide 19 of 31
May 2006
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
Slide 20 of 31
May 2006
HVAC
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
Slide 21 of 31
May 2006
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
Slide 22 of 31
May 2006
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
Slide 23 of 31
May 2006
HVAC
Temperature and relative humidity (RH) (2)
Remove moisture, or add moisture as necessary
Dehumidification
Refrigerated dehumidifiers with cooling media
Chemical dehumidifiers
Slide 24 of 31
May 2006
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
Slide 25 of 31
May 2006
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
Slide 26 of 31
May 2006
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
HVAC
Slide 27 of 31
May 2006
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
Slide 28 of 31
May 2006
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
HVAC
Slide 29 of 31
May 2006
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
Wet scrubbers
Use suitable drainage system for dust slurry
6.1.11 6.1.15
Slide 30 of 31
May 2006
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
HVAC
Slide 31 of 31
May 2006
6.2.1 6.2.5