21 CFR § 1271.195 - Environmental control and monitoring.
---
identifier: "/us/cfr/t21/s1271.195"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.195 - Environmental control and monitoring."
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.195"
section_name: "Environmental control and monitoring."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "L"
subchapter_name: "REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION"
part_number: "1271"
part_name: "HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 243, 263a, 264, 271."
regulatory_source: "66 FR 5466, Jan. 19, 2001, unless otherwise noted."
cfr_part: "1271"
---
# 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.