(a) Environmental control. Where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents, you must adequately control environmental conditions and provide proper conditions for operations. Where appropriate, you must provide for the following control activities or systems:
- (1) Temperature and humidity controls;
- (2) Ventilation and air filtration;
- (3) Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations; and
- (4) Maintenance of equipment used to control conditions necessary for aseptic processing operations.
- (b) Inspections. You must inspect each environmental control system periodically to verify that the system, including necessary equipment, is adequate and functioning properly. You must take appropriate corrective action as necessary.
- (c) Environmental monitoring. You must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms.
- (d) Records. You must document, and maintain records of, environmental control and monitoring activities.