Why is an air handling unit used in the Pharmaceutical industry?

An AHU is a device used to condition and circulate air as part of a ventilating, heating, and air-conditioning (HVAC) system. An air handler is typically a large metal box containing heating or cooling elements, blower, sound attenuators, filter racks or chambers, and dampers. Air handlers typically attach to a ductwork ventilation system which allocates the conditioned air through the building and returns it to the AHU. At times AHUs discharge and admit air directly to and from the space served devoid of ductwork.

Small air handlers, for local use, are known as terminal units and may only include a coil, air filter, and blower; these simple terminal units are known as blower coils or fan coil units. An ahu design in pharma that conditions 100% outside air, and no recirculated air, is known as a makeup air unit (MAU). An air handler meant for outdoor use, usually on roofs, is a packaged unit (PU) or rooftop unit (RTU).

Criteria for validation

During AHU validation, the tests shall be done

Air velocity & number of air changes,
Filter efficiency test,
Differential pressure, temperature, and RH
Airflow pattern (visualization)
Dynamic condition qualification
Static condition area qualification
Non-viable count
Area recovery and power failure study
Microbial monitoring

Why should re-validation be performed?

As per pharma consultants in India, the AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be revalidated in the following cases as well.

When cleanroom volume is changed,
When the basic design of AHU is changed,
When construction is carried out, that calls for the reconstruction of the AHU system
When new equipment is installed

Pharmaceutical AHU and HVAC are offered to heat the air to raise the dew point for humidity control.

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