publication . Article . 2002

A cleanroom contamination control system

Whyte, W.; Eaton, T.;
Open Access English
  • Published: 01 Jan 2002
  • Publisher: Euromed Communications Ltd.
  • Country: United Kingdom
Abstract
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 reinterpretation for use in\ud pharmaceutical manufacturing. This paper suggests a possible system.\ud To control contamination effectively, it is necessary to have a good appreciation of the routes and\ud sources of contamination, and the means of controlling them. An overview of these is given.
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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.

11. Whyte W. 'Sterility assurance and models for assessing airborne bacterial contamination'. Journal of Parenteral Science and Technology 1986; 40: 188-197.

12. Whyte W. 'In support of settle plates', PDA Journal of Pharmaceutical Science & Technology 1996; 50: 201.

13. Whyte W, Matheis, W, Dean-Netcher, M and Edwards, A. 'Airborne contamination during blow-fill-seal pharmaceutical production'. PDA Journal of Pharmaceutical Science & Technology 1998; 52: 89-99.

14. Ljungqvist B and Reinmüller B. 'Hazard analysis of airborne contamination in cleanrooms - application of a method of limitation of risks'. PDA Journal of Pharmaceutical Science and Technology 1995; 49: 239-243.

15. Reinmüller B. 'HACCP and microbiological risk assessment in aseptic production'. The Nordic Journal of Contamination Control and Cleanroom Technology 1999; 28(1): 9-12.

17 references, page 1 of 2
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