§ 211.46 Ventilation, air filtration, air heating and cooling

(a) Adequate ventilation shall be provided.

(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.

(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.

(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 211.46

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Equipment for Environmental Control 165
• Exhaust systems inadequate to control air contamination 21
• Air filtration system lacking in production area 21
• Penicillin air handling systems not kept separate 7
• Adequate ventilation not provided 6
• Air recirculation of dust from production areas 4

Warning letters citing § 211.46

5 FDA warning letters since 2017 cite this section :

• Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals 17 Dec 2024
• Family Pharmacy of Statesville, Inc. 6 Nov 2020
• Lernapharm (Loris) Inc. 4 Sept 2018
• Goran Pharma Pvt Ltd 24 Apr 2018
• American CryoStem Corporation 3 Jan 2018

FDA guidance that cites § 211.46

• Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 19 Oct 2023
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry draft 24 Jun 2022
• Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry draft 29 Sept 2021
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for Industry 17 Apr 2013
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978