21 C.F.R. § 211.46

Ventilation, air filtration, air heating and cooling

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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.

Notes of Decisions

Cited in 3 cases, 1988–1993 · leading case: John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988).

Sort: Relevance Newest Treatment

John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988). “” 21 C.F.R. § 211.46 (b); see 52 Fed.Reg. at 29303.”

United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992). “21 C.F.R. § 211.46 . Evaluating the evidence presented in the case at bar in conjunction with all of the foregoing standards and regulations, this Court can come to no other conclusion but that the entry of a preliminary injunction against the Defendants is proper at this time…”

United States v. Richlyn Labs., Inc., 822 F. Supp. 268 (E.D. Pa. 1993). “21 C.F.R. § 211.46 . At bar, after reviewing all of the evidence presented at both the preliminary injunction and contempt hearings and that provided in support of and in opposition to the instant motion in the light most favorable to the Defendants, we find that Plaintiff has…”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.