# 21 CFR § 211.46: Ventilation, air filtration, air heating and cooling

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-211.46

## Section

- **Citation:** 21 CFR § 211.46
- **Heading:** Ventilation, air filtration, air heating and cooling
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** 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

## Text

(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.

## Nearby sections

- [21 CFR § 211.1 § 211.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.1.md)
- [21 CFR § 211.3 § 211.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.3.md)
- [21 CFR § 211.22 § 211.22 Responsibilities of quality control unit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.22.md)
- [21 CFR § 211.25 § 211.25 Personnel qualifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.25.md)
- [21 CFR § 211.28 § 211.28 Personnel responsibilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.28.md)
- [21 CFR § 211.34 § 211.34 Consultants.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.34.md)
- [21 CFR § 211.42 § 211.42 Design and construction features.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.42.md)
- [21 CFR § 211.44 § 211.44 Lighting.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.44.md)
- [21 CFR § 211.46 § 211.46 Ventilation, air filtration, air heating and cooling.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.46.md)
- [21 CFR § 211.48 § 211.48 Plumbing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.48.md)
- [21 CFR § 211.50 § 211.50 Sewage and refuse.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.50.md)
- [21 CFR § 211.52 § 211.52 Washing and toilet facilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.52.md)
- [21 CFR § 211.56 § 211.56 Sanitation.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.56.md)
- [21 CFR § 211.58 § 211.58 Maintenance.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.58.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-211.46. Check the current official text before relying on it. Not legal advice.