Assessment of degree of risk from sources of microbial contamination in cleanrooms; 1: Airborne

Whyte, W. and Eaton, T. (2015) Assessment of degree of risk from sources of microbial contamination in cleanrooms; 1: Airborne. European Journal of Parenteral and Pharmaceutical Sciences, 20(2), pp. 52-62.

Abstract

The degree of risk from microbial contamination of manufactured products by sources of contamination in healthcare cleanrooms has been assessed in a series of three articles. This first article considers airborne sources, and a second article will consider surface contact and liquid sources. A final article will consider all sources and the application of the risk method to a variety of cleanroom designs and manufacturing methods. The assessment of the degree of risk from airborne sources of microbial contamination has been carried out by calculating the number of microbes deposited from the air (NMDA) onto, or into, a product from various sources. A fundamental equation was used that utilises the following variables (risk factors): concentration of source microbes; surface area of product exposed to microbial deposition; ease of microbial dispersion, transmission and deposition from source to product; and time available for deposition. This approach gives an accurate risk assessment, although it is dependent on the quality of the input data. It is a particularly useful method as it calculates the likely rate of product microbial contamination from the various sources of airborne contamination.

• 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
• ISSN (Online): 1740-6277
• Copyright Holders: Copyright © 2015 The Authors
• First Published: First published in European Journal of Parenteral and Pharmaceutical Sciences 20(2):52-62
• Publisher Policy: Reproduced with the permission of the publisher