Remember Me
Or use your Academic/Social account:


Or use your Academic/Social account:


You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.


Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message


Verify Password:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Whyte, W.; Eaton, T. (2004)
Publisher: Euromed Communications Ltd.
Languages: English
Types: Article
This paper describes the fundamental mechanisms of microbial contamination during manufacture\ud of pharmaceutical products. Models are derived that describe air and surface contact contamination.\ud These models can be used to develop and improve methods of microbial risk assessment. The use of\ud the FMEA (FMECA) method of risk assessment is discussed and, when used with the correct risk\ud factors, its use endorsed.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1. Guidance for pharmaceutical manufacturers and distributors, ISBN 0-11-322-559-8. The Stationary Office, UK, 2002.
    • 2. ISO 14698-1. Cleanrooms and associated controlled environments - Biocontamination control: Part 1: General principles and methods. Geneva, Switzerland, International Organization for Standardization, 2003.
    • 3. US Food and Drug Administration Centre for Drug Evaluation and Research. Pharmaceutical cGMPs for the 21st Century - a risk-based approach. In: News along the Pike'. August 30, 2002; 1 and 14.
    • 4. IEC 61025-1990, Fault Tree Analysis (FTA). Geneva, Switzerland, International Electrotechnical Commission, 1990.
    • 5. IEC 812-1985, Analysis techniques for system reliability - Procedure for failure mode and effect analysis (FMEA). Geneva, Switzerland, International Electronic Commission, 1985.
    • 6. Kletz T (1999). Hazop and Hazan, ISBN 0852954212. Institute of Chemical Engineers, Rugby, UK.
    • 7. 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.
    • 8. HACCP - Introducing the Hazard Analysis and Critical Control Point System. Food Safety Unit, World Health Organization. Document number WHO/FSF/FOS/97.2, 1997.
    • 9. Kieffer RG, Bureau S, Borgmann A. Applications or failure mode effect analysis in the pharmaceutical industry. Pharmaceutical Technology Europe, September 1997.
    • 10. Sandle T. The use of risk assessment in the pharmaceutical industry - the application of FMEA to a sterility testing isolator: a case study. European Journal of Parenteral and Pharmaceutical Sciences 2003; 8(2); 43-49.
    • 11. Whyte W. A cleanroom contamination control system. European Journal of Parenteral Sciences 2002; 7(2): 55-61.
    • 12. MacIntosh C, Lidwell OM, Towers AG, Marples, R. The dimensions of skin fragments dispersed into the air during activity. Journal of Hygiene, Cambridge 1978; 81: 471.
    • 13. Whyte W, Bailey PV. Reduction of microbial dispersion by clothing. Journal of Parenteral Science and Technology 1985; 39: 51-60.
    • 14. Noble WC, Lidwell OM, Kingston D. The size distribution of airborne particles carrying microorganisms. Journal of Hygiene 1963; 61: 385.
    • 15. Whyte W. Sterility assurance and models for assessing airborne bacterial contamination. Journal of Parenteral Science and Technology 1986; 40: 188-197.
    • 16. Whyte W, Matheis W, Dean-Netcher M, Edwards A. Airborne contamination during blow-fill-seal pharmaceutical production. PDA Journal of Pharmaceutical Science & Technology 1998; 52: 89-99.
    • 17. Whyte W and Eaton T. Microbial risk assessment in pharmaceutical cleanrooms. European Journal of Parenteral and Pharmaceutical Sciences 2004; 9(1): 17-24.
  • No related research data.
  • No similar publications.

Share - Bookmark

Download from

Cite this article