Current Perspectives on Environmental Monitoring

Sinopse

It is perhaps easier to explain what this booklet is not, for the aim is not to offer a beginners guide to the environmental monitoring of sterile and non-sterile environments. There are several text books on this subject as well as a course on pharmaceutical microbiological environmental monitoring run by the University of Manchester (the PMAT programme). What then is the purpose of this booklet? The aim of this booklet is to survey some of the current practices, trends and approaches to environmental monitoring and present these as technical articles in a way which will be of interest to those with some experience with pharmaceutical microbiology. In doing so note of the current interest in risk assessment is accounted for and several chapters directly or indirectly describe how risk assessment is an advantage for environmental monitoring, using practical examples. Risk assessment can, for example, help with the selection of sample sites or with working how often to monitor; it is also useful in problem solving. Environmental monitoring is an important part of pharmaceutical manufacturing and it typically falls under the responsibility of QC Microbiology to devise and manage the monitoring programme using viable and non-viable methodologies. The articles collected in this booklet include some published for the first time and others previously published, but now out-of-print, from past editions of Pharmig News. These latter articles have not simply been re-printed. They have been reviewed, updated and edited where appropriate whilst keeping the main thrust of the author s argument intact. About the Author