Glossary
Air Handling
Equipment and its operation that condition air for temperature, humidity, and cleanliness and deliver the required airflow.
Details
Air handling is both the means by which a cleanliness grade is created and a route along which contamination travels, so a design fault in one area becomes contamination in another. The corpus includes air carrying unrefined intermediate that was found to contaminate as it passed through the air handling unit, cleanroom air handling whose qualification had not been completed, limits exceeded with no action taken, and inadequate air handling design in unclassified areas. Look together at the balance of supply and extract, the pressure differentials between areas, filter specifications and replacement history, and what was done when a limit was exceeded.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Specifically, on July 14, 2023, your Quality Assurance team observed a box of food from June 16, 2023, covered in scuttle fly pupae in the mechanical room which houses the air handling units and failed to remove the box of food until July 31, 2023.
FDA · FDA Warning Letter · 2024-08-27 -
Before transporting the dried intermediates, the air passes through an air handling unit (AHU).
EMA · EU GMP NCR (EudraGMDP) · 2024-08-16 -
Air handling design for the unclassified production room was observed to be inadequate on 06/19/17, in that the HEPA filters supplying air to the room are located adjacent to the returns, all of which are located on the ceiling.
FDA · FDA 483 · 2025-06-20
