USA/EC/ISO regulatory considerations for designing aseptic processing facilities

Pharmaceutical Engineering

Volumn 24, Issue 4, 2004, Pages 36-46

  Del Valle, Manuel A ^a  

^a FLUOR CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASEPSIS; BIOTECHNOLOGY; EUROPE; GOOD MANUFACTURING PRACTICE; INSTRUMENT STERILIZATION; PARTICULATE MATTER; PRACTICE GUIDELINE; REVIEW; UNITED STATES;

EID: 4344627126     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Federal Standard 209E - Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, 11 September 1992. Revised 1992 by the Institute of Environmental Sciences (and Technology), 940 E. Northwest Highway, Prospect, IL. 60056, Tel: 1-708/255-1561, Fax: 1-708/255-1699.
2. ISO 14644 - Clean Room and Associated Controlled Environments. International Organization for Standardization, Case Postale 56, CH-1211 Geneve 20, Switzerland, Internet iso@iso.ch
3. 1997 EC Guide to Good Manufacturing Practice, Annex 1 - Manufacture of Sterile Medicinal Products. This European Community GMP guide is found in the publication known as "The Orange Guide," published by the British "Medicines Control Agency" or MCA titled, "Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002," published by TSO (The Stationary Office), www.tso.co.uk/bookshop, Tel: 44-8706005522.
4. Guideline on Sterile Drug Products Produced by Aseptic Processing - June, 1987 by the Center for Drugs and Biologics, Food and Drug Administration (FDA), Rockville, MD.
5. Commission of the European Communities. The rules governing medicinal products in the EC. Vol. IV. Good Manufacturing Practice for Medicinal Products. Luxembourg: Office for Official Publications of the EC, 1992. ISBN92-826-3180-X.
6. ISPE Baseline® Pharmaceutical Engineering Guides, ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa, FL 33607, Tel: 1-813/960-2105, Fax: 1-813/264-2816, Web site: www.ispe.org.