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As an experienced and full-service group, SMB has validated Heating, Ventilation, and Air Conditioning (HVAC) systems and their microprocessor controllers in multi-unit, multi-zone manufacturing/R&D facilities.

Validation of an HVAC system requires a thorough understanding of the facility design, and the purpose of each zone/room in the facility. What are the areas and zones in the facility? What are their classes? What area(s) does each particular Air Handling Unit (AHU) service? Are these 100% fresh air supply AHU's, or do they incorporate return air? What control system is in place to monitor and regulate air temperature, humidity, and pressure differentials? How many air changes per hour are required for each zone? Each room? These are all questions that need to be answered to understand the design intent of a facility's HVAC system.

Next the validation strategy should be determined, including the length and intensity of the validation effort (number of sampling weeks and number samples in a day), the status of the facility during sampling (Static? Dynamic? Both?), and the sampling strategy (how and where will samples be taken (temperature, humidity, pressure, particulate) and what are the acceptance criteria).

The HVAC system's controller requires careful study, too. Is this a rudimentary system controlling a single AHU, or a complex, microprocessor-based control servicing multiple AHU's? Is the control system part of a Building Automation (or Management) System responsible for security, fire, etc.? How will your validation activities impact the BAS/BMS? Is this functionality being added on to an existing control system? How will your validation activities affect the existing validation? How should the room sampling regime coincide with reporting from the BAS/BMS? What aspects of GAMP should be incorporated into your validation efforts?

Once you have a clear answer to these and other questions, you can begin to write your protocols.

Obviously, the validation of an HVAC system can be a daunting task for a validation department with stretched resources. Make SMB's experience work for you on your next HVAC validation project.

From design qualification (DQ) through installation qualification (IQ), operational qualification (OQ) and process qualification (PQ) we are able to develop a Heating, Ventilation and Air Conditioning validation package to suit you.

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