Good Manufacturing Practices: HVAC: Heating, Ventilation and Air-Conditioning (HVAC)

Good Manufacturing Practices: HVAC
Heating, Ventilation
and Air-
Conditioning (HVAC)
Part 2: Air flows,

Pressure concepts
WHO Technical Report Series,
No. 961, 2011. Annex 5
HVAC | Slide 1 of 47 2013

HVAC
Objectives
To continue from previous section of Part 1, now focus on:
Air filtration and air flow patterns
The role of HVAC in dust control
HVAC system design and its components (part 3)
Commissioning, qualification and maintenance (part 4)

HVAC
Air Filtration
Degree of filtration of air is important to prevent contamination
Type of filters to be used is dependent on:

Quality of ambient air,
Return air / re-circulation
Air change rates
National requirements
Products and required class of clean room etc.
Manufacturer to determine, select and install appropriate filters

for use 4.2.1, 4.3.3

HVAC
Levels of protection and recommended filtration

Level of Recommended filtration
protection
Level 1 Primary filters, e.g. EN779 G4
Level 2 Production area with 100% outside air: Primary plus

secondary filter (e.g. EN779 G4 plus F8 or F9 filters)
Level 3 Production facility operating on re-circulated plus ambient air, where

potential for cross-contamination exists: Primary plus secondary
plus tertiary filters (e.g. EN779 G4 plus F8 plus EN1822 H13 filters)
(For full fresh air system, without recirculation, G4 and F8 or F9
filters are acceptable) 4.2.1 - 2

HVAC
Contamination can be prevented by considering:
Appropriate materials of construction of HVAC components
Placement of components (e.g. upstream of final filters)
Design and appropriate access (from outside) to dampers,
filters and other components
Personnel operations and protection
Airflow direction
Air distribution component design, installation and location
Diffusers (type, design, location)
4.2.4 4.2.10
Air supply and air exhaust location

HVAC
Induction diffuser
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Perforated plate
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Swirl type diffuser

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

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

HVAC
Unidirectional airflow (UDAF)
Often used in weighing and sampling areas

(Airflow Protection Booths) and provides:
Dust containment and product and operator protection
Note: For Airflow Protection Booths (APB):
Airflow velocity should not affect balance (may be lower than
for Class A areas)
Position of material, balance, operator determined and
validated no obstruction of airflow or risk 4.3

HVAC
Airflow patterns
Workbench (vertical) Cabin/booth Ceiling

HVAC
Unidirectional airflow (UDAF):
Sampling and weighing area classification same as other
processing areas following sampling and dispensing
Dust containment shown through smoke tests as part of
validation / qualification
Location and type of return and exhaust grilles
Cleaning and maintenance
Will discuss examples in the following figures
4.3.

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Infiltration
Prevent infiltration of unfiltered, contaminated air

from outside
Facilities normally under positive pressure to the

outside
4.4.1 4.4.4
Building structure well sealed
Some cases - negative pressure (e.g. penicillin

manufacture). Special precautions to be taken. See
separate guidelines
HVAC
Cross-contamination
Multiproduct facility even if in different areas - risk for

cross contamination (dust from area to area)
Correct direction of air movement and pressure cascade
Normally, corridors positive to cubicles and cubicles

positive to atmosphere
Consider building structure, ceilings, walls, doors etc
Different concepts discussed in following slides 4.5

HVAC
Displacement concept
Not a preferred method (Found in older facilities)
Based on low pressure differentials and high airflows
Air supplied to the corridor then through the doors

(grilles) to the cubicles
Air extracted at the back of the cubicle
Velocity high enough to prevent turbulence in doorway

4.6

HVAC
Pressure differential concept
Used where there is low dust in areas. Alone or in combination
with other control techniques
High pressure differential, low airflow, and airlocks
Airlock types include: Cascade, sink and bubble type (See

next slides)
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 4.7

extraction systems in cubicles
HVAC
Essential / critical parameter here is pressure differentials
Risk assessment may be done
High enough to achieve containment; low permissible when

airlocks are used
No flow reversal should take place therefore appropriate

limits e.g. 5Pa to 20 Pa
No turbulence
No overlap (two adjacent rooms)
4.7

HVAC
Adequate room pressure differential indication provided
Each critical room pressure must be traced back to ambient

pressure (by summation of the room pressure differentials)
provides actual absolute pressure
Gauges with appropriate range and graduation scale to enable

accurate reading; analogue or digital; as pressure differentials or
absolute pressures
Normal operating range, alert and action limits defined and

displayed
4.7
OOS condition should be easily identifiable

HVAC

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Calibrated and qualified monitoring devices, verified at
intervals
Linked to alarm system
Monitoring and recording of results
Doors open to higher pressure, self closers
Doors interlocked where possible
4.7

HVAC
Dust extraction system design is important as it may
impact on pressure cascade
Central systems interlocked with AHUs
No airflow between rooms through common system
What happens in the case of component failure?
4.7

HVAC
Airlocks and Material Pass-though-hatches (PTH)
Can be used to separate two zones
Dynamic and passive PTH
Also designed as bubble, sink or cascade
See next slides for design principles

4.7

HVAC

HVAC
What type of airlock

is this?
How does it work?
Any examples of where

It can be used?

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

prevent cross-contamination
Closed systems
Pump or vacuum transfer
4.8

HVAC
Temperature and relative humidity (RH)
Consider materials and product requirements as well as

operator comfort in the design of the HVAC
Where conditions are required, provide for control,

monitoring and recording
Alert and action limits; minimum and maximum limits
Premises appropriately designed 4.9
HVAC design to achieve and maintain conditions in

different seasons
HVAC
Relative humidity (RH)
Low RH areas need well sealed walls and ceilings, and
preferably air locks
Remove or add moisture as necessary
Dehumidification
Refrigerated dehumidifiers - cooling media
Chemical dehumidifiers
Humidifiers should not be sources of contamination
Use of pure steam or clean steam 4.9
No chemicals that can have a detrimental effect

HVAC
Relative humidity (RH)
Humidifiers should be well drained - 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
4.9

HVAC
Dust Control 5.1. 5.6
Where possible - 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 in

extraction system to prevent dust
settling in ducting
Calculations and
measurements
Periodic checks for build up
Risk analysis airflow direction

HVAC
Dust Control (2)
Normally air supplied through ceiling diffusers, near the door
Air extracted from low level (rear)
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
5.7. 5.8.
Fresh air rate supply
comfort, odour and fume removal, leakage, pressure control, etc.

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Exhaust air dust
Dust collection
6.1.1 6.1.2 Exhaust air from equipment and
system some areas of production can
carry heavy loads of dust,
vapours and fumes (e.g. FBD,
coating, weighing)
Filtration may be needed to
protect environment (see
National legislation)
Location of the inlet and exhaust
points relative to one other
important to prevent
contaminants taken into inlet air

HVAC
Exhaust air dust
Wet scrubbers can also be used
Contaminated air is collected
Dust is treated with a mist/spray

/ water
Clean air is exhausted

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Good Manufacturing Practices: HVAC

Part 2: Air flows,

HVAC | Slide 1 of 47 2013

Air filtration and air flow patterns

The role of HVAC in dust control

HVAC system design and its components (part 3)

Commissioning, qualification and maintenance (part 4)

HVAC | Slide 2 of 47 2013

Type of filters to be used is dependent on:

Manufacturer to determine, select and install appropriate filters

HVAC | Slide 3 of 47 2013

Levels of protection and recommended filtration

Level 2 Production area with 100% outside air: Primary plus

Level 3 Production facility operating on re-circulated plus ambient air, where

HVAC | Slide 4 of 47 2013

HVAC | Slide 5 of 47 2013

Swirl type diffuser

Other technologies: barrier technology/isolator technology.

HVAC | Slide 9 of 47 2013

HVAC | Slide 10 of 47 2013

HVAC | Slide 11 of 47 2013

Airflow patterns Prefilter

Turbulent Unidirectional Turbulent

HVAC | Slide 12 of 47 2013

Often used in weighing and sampling areas

HVAC | Slide 13 of 47 2013

HVAC | Slide 14 of 47 2013

HVAC | Slide 15 of 47 2013

HVAC | Slide 16 of 47 2013

HVAC | Slide 17 of 47 2013

HVAC | Slide 18 of 47 2013

HVAC | Slide 19 of 47 2013

HVAC | Slide 20 of 47 2013

HVAC | Slide 21 of 47 2013

HVAC | Slide 22 of 47 2013

Prevent infiltration of unfiltered, contaminated air

Facilities normally under positive pressure to the

Some cases - negative pressure (e.g. penicillin

Multiproduct facility even if in different areas - risk for

Correct direction of air movement and pressure cascade

Normally, corridors positive to cubicles and cubicles

Consider building structure, ceilings, walls, doors etc

Different concepts discussed in following slides 4.5

HVAC | Slide 25 of 47 2013

Not a preferred method (Found in older facilities)

Based on low pressure differentials and high airflows

Air supplied to the corridor then through the doors

Air extracted at the back of the cubicle

Velocity high enough to prevent turbulence in doorway

HVAC | Slide 26 of 47 2013

High pressure differential, low airflow, and airlocks

Airlock types include: Cascade, sink and bubble type (See

Sufficient pressure differential required to ensure containment

Consider effect of other items such as equipment and 4.7

Risk assessment may be done

High enough to achieve containment; low permissible when

No flow reversal should take place therefore appropriate

No overlap (two adjacent rooms)

HVAC | Slide 28 of 47 2013

Each critical room pressure must be traced back to ambient

Gauges with appropriate range and graduation scale to enable

Normal operating range, alert and action limits defined and

HVAC | Slide 29 of 47 2013