CFR — Code of Federal Regulations Title 21 Part 211 Subpart C — Buildings and Facilities § 211.46 — Ventilation, air filtration, air heating and cooling.

[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.46]

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart C – Buildings and Facilities

Sec. 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.

As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.