Whyte, W. and Eaton, T. (2004) Microbial risk assessment in pharmaceutical cleanrooms. European Journal of Parenteral and Pharmaceutical Sciences, 9(1), pp. 16-23.
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Abstract
The microbial risk to aseptically manufactured products in pharmaceutical cleanrooms can be assessed by the use of fundamental equations that model the dispersion, transfer and deposition of microbial contamination, and the use of numerical values or risk descriptors. This can be done in two-stages, with the first stage used to assess the transfer of contamination from all of the sources within the cleanroom suite and the second stage used to assess both air and surface contact contamination within critical production areas. These two methods can be used to assess and reduce microbial risk at the preliminary design stage of the cleanroom and associated manufacturing process or, retrospectively, for an established manufacturing operation.
| 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):16-23 |
| Publisher Policy: | Reproduced in accordance with the permission of the publisher. |
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