Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3: Overall application

Whyte, W. and Eaton, T. (2017) Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3: Overall application. European Journal of Parenteral and Pharmaceutical Sciences, 22(2), pp. 38-49.

Abstract

A method of calculating the degree of risk of sources of microbial contamination to products manufactured in cleanrooms has been described in two previous articles. The degree of risk was ascertained by calculating the number of microbes deposited (NMD) onto, or into, a product from each source of contamination. The first article considered airborne sources, the second article considered surface and liquid sources, and this final article considers all three sources. The NMD method can be applied to various manufacturing methods and designs of cleanrooms but was illustrated by a vial-filling process in a unidirectional airflow (UDAF) workstation located in a non- UDAF cleanroom. The same example was used in this article to demonstrate how to control the microbial risk, and included the use of a restricted access barrier system. The risk to a patient is not only dependent on microbial contamination of pharmaceutical products during manufacture in cleanrooms and controlled zones but the chance that any microbes deposited in the product will survive and multiply during its shelf life, and this aspect of patient risk is considered.

• 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
• ISSN: 0964-4679
• Copyright Holders: Copyright © 2017 Euromed Communications
• First Published: First published in European Journal of Parenteral and Pharmaceutical Sciences 2292):38-49
• Publisher Policy: Reproduced with the permission of the publisher