Microbiological contamination models for use in risk assessment during pharmaceutical production

Whyte, W. and Eaton, T. (2004) Microbiological contamination models for use in risk assessment during pharmaceutical production. European Journal of Parenteral and Pharmaceutical Sciences, 9(1), pp. 11-15.

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Abstract

This paper describes the fundamental mechanisms of microbial contamination during manufacture of pharmaceutical products. Models are derived that describe air and surface contact contamination. These models can be used to develop and improve methods of microbial risk assessment. The use of the FMEA (FMECA) method of risk assessment is discussed and, when used with the correct risk factors, its use endorsed.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Whyte, Dr William
Authors: Whyte, W., and Eaton, T.
College/School:College of Science and Engineering > School of Engineering
Journal Name:European Journal of Parenteral and Pharmaceutical Sciences
Publisher:Euromed Communications Ltd.
ISSN:0964-4679
ISSN (Online):1740-6277
Copyright Holders:Copyright © 2004 The Pharmaceutical and Healthcare Sciences Society
First Published:First published in European Journal of Parenteral and Pharmaceutical Sciences 9(1):11-15
Publisher Policy:Reproduced in accordance with the permission of the publisher.

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