this graphic represents the city skyline of one of our HVAC validation customers.


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 product.

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 specified specifications.

Energy Requirements and Efficiencies.

This graphic depicts the relationship between weight of water in HVAC validation.

Two 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 electricity.

The 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.

The 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.

Typical 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.  Furthermore, this 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 cooling.

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.

This graphic depicts various of the parameters that are standards for HVAC validation. t

Documents Available.

This combined HVAC SOP and IQ template makes it so easy for you to raise a quality IQ. With the new suite of HVAC documents from the DQ - IQ - OQ - PQ, all user friendly and ready to go, your validation life has got much simpler. The final product is a professional and comprehensive Heating Ventilation and Air Conditioning Installation Validation Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day, or a complete suite in one day.


This easy to use HVAC Operational Validation SOP and Protocol, can be simply and quickly converted (using find replace techniques) into your own company bespoke document. Now you can purchase these document in a suite DQ to PQ, getting you ready at express speed to qualify a system. It has never been quicker or simpler.

More room standards that are required for HVAC 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.