Introduction to HVAC Validation.
Where environmental conditions, such as
temperature, humidity, particle content and biological contamination are
important aspects of pharmaceutical, biotechnical and or medical device
production, validation and qualification of the HVAC system must be performed.
This validation must utilize a risk-based approach,
which involves a high level of process understanding and focuses on potential
problems, risks, and all suitable countermeasures. The validation must verify that in all
areas where drugs or raw materials have air contact, the air cannot adversely
affect the quality or efficacy of the
To fulfil regulatory requirements, a clean
room HVAC system must
maintain environmental condition within specified specifications. These conditions must be regularly
monitored to ensure constant awareness of environmental conditions, such as
temperature, humidity, pressure and particle levels. Digital outputs for alarms
must also be monitored to ensure that an alarm will be raised if there is a
change in any of the designated parameters.
All such environmentally controlled areas,
zones and or rooms must be included in a preventative maintenance and calibration program that will monitor all trends and ensure
continued use within the User Requirements
Energy Requirements and Efficiencies.
essential requirements for comfortable and healthy indoor environments are
adequate ventilation and good humidity control. Unfortunately in
humid climates, which includes much of the densely populated regions of the
world, it is difficult to meet both these requirements without using a lot of
fundamental problem is that a conventional cooling coil (whether using chilled
water or direct-expansion refrigerant) cannot effectively meet the latent loads
from ventilation on very humid days. All conventional chillers and air
conditioners are essentially sensible cooling devices that dehumidify by
lowering air temperature below its dewpoint so that moisture condenses. These systems must run with a wet
cooling coil and the air that leaves this coil must be close to saturation.
limitation of conventional chillers and direct-expansion (DX) air conditioners
becomes evident when one tries to use them in an advanced HVAC system. Technologies such as displacement
ventilation, chilled beams, and radiate panels can be part of a low-energy HVAC
system that eliminates the fan energy used in a conventional system that
recirculates large volumes of air.
However, these advanced systems will not work with a conventional chiller
or DX air conditioner that supplies relatively cold air (e.g., 50 to 55 F) that
is saturated with moisture (i.e., 100% rh). What is required is a cooling system
that supplies drier, but warmer air.
supply air conditions for displacement ventilation are 65 F and 50% relative
humidity. This supply air has an
absolute humidity of 45.5 grains moisture per pound of dry air (which is
equivalent to a humidity ratio of 65 g/kg and a dewpoint of 46.0 F). Any cooling system that dehumidifies air
by reducing its temperature to condense the moisture must first cool air to
below 46 F and then reheat the air to 65 F. As shown on the neighboring
psychrometric chart, a cooling system that process 6,000 cfm of warm, humid
outdoor air must do 54.0 tons of cooling and then 10.8 tons of reheating. This air conditioner is doing 25% more
cooling than is required to meet the load.
percent excess cooling becomes much larger during cooler, damp weather, e.g., if
it were 70 F and raining, overcooling would be 42% of the required
This cycle is seldom understood by management, who
consequently fail to realise that the rise in energy consumption of a
system 'out of calibration' can be very very substantial. These systems
should be subjected to annual calibration and a defined method of tuning to attain minimum energy consumption.
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HVAC PERFORMANCE VALIDATION.
This fully formatted HVAC Performance Validation is the last in the chain of qualifying tests that HVAC systems are subjected to, before being considered qualified. However environmental validation is required to verify air quality.