A cleanroom contamination control system

Article English OPEN
Whyte, W.; Eaton, T.;
(2002)
  • Publisher: Euromed Communications Ltd.

Analytical methods for hazard and risk analysis are being considered for controlling contamination\ud in pharmaceutical cleanrooms. The most suitable method appears to be the HACCP system that has\ud been developed for the food industry, but this requires some reinterpr... View more
  • References (17)
    17 references, page 1 of 2

    1. The Rules Governing Medicinal Products in the European Union. Volume 4. 'Good manufacturing practices - Medicinal products for human and veterinary use'.

    2. Draft ISO 14698-1. 'Cleanrooms and associated controlled environments-biocontamination Control': Part 1: 'General principles and methods', 2001.

    3. IEC 61025-1990, Fault Tree Analysis (FTA). Geneva, Switzerland: International Electrotechnical Commission, 1990.

    4. IEC 812-1985, 'Analysis techniques for system reliability - Procedure for failure mode and effect analysis'. (FEMA). Geneva, Switzerland: International Electronic Commission, 1985.

    5. Hazard Analysis and Critical Control Point Principles and Application Guidelines. National advisory committee on microbiological criteria for foods, U.S. Food and Drug Administration, 1997.

    6. Hazard Analysis Critical Control Point (HACCP) system and guidelines for its application. 1995 Codex Alimentarius Commission. Alinorm 97/13. Annex to Appendix II. Joint FAO/WHO Food Standards Programme, Rome: Food and Agricultural Organization of the United Nations, 1995.

    7. HACCP - Introducing the Hazard Analysis and critical control point system. Food Safety Unit, World Health Organization. Document number WHO/FSF/FOS/97.2, 1997

    8. Jahnke M. 'Use of the HACCP concept for the risk analysis of pharmaceutical manufacturing process'. European Journal of Parenteral Sciences 1997; 2(4): 113-117.

    9. Løvtrup S. 'Risk assessment in the manufacture of medical products based on design and barrier assessment (DaBA)'. European Journal of Parenteral Sciences 2001; 6(2): 53-57.

    10. Whyte W, Bailey P V, Tinkler J, McCubbin I, Young L and. Jess J. 'An evaluation of the routes of bacterial contamination occurring during aseptic pharmaceutical manufacturing'. Journal of Parenteral Science and Technology 1982; 36: 102-107.

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