---
kind: "section"
citation: "21 C.F.R. § 1271.195"
title: "21"
number: "1271.195"
heading: "Environmental control and monitoring."
url: "https://uscodex.org/cfr/21/1271.195"
---

# §1271.195. Environmental control and monitoring.

- (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.

## Notes

### Source

Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.