Meeting regulatory expectations

Published: 9-Jan-2015

Best practice and meeting the expectations of regulators on the use of plant isolates, bioburden strategies, rapid ID methods, auditing environmental controls and deviation management are topics taxing microbiologists. Susan Birks reports on issues discussed at the Pharmig conference

You need to be a subscriber to read this article.
Click here to find out more.

Research is revealing more information about microbes found on humans and in the manufacturing environment, changing the way microbiological strategies and tests are devised. Pharmig’s annual conference, held in Nottingham, UK, highlighted some areas where pharmaceutical regulators have embraced these new concepts but have not, as yet, mandated or specified procedures in the standards.

Tim Sandle, Site Microbiologist, Bio Products Laboratory (BPL) began the proceedings by looking at recent research from the Human Microbiome Project (HMP) and its implications for cleanroom microbiology. Research on the HMP has revealed that there are some 1,000 different species of microbes found on men and women, and it is now recognised that a human adult houses about 1012 bacteria on the skin, 1010 in the mouth and 1014 in the gastro-intestinal tract. There is also a considerable diversity of species and a variation between individuals.

The skin is now regarded as an ecosystem with different areas populated by different species. Knowing what is there is important because people can shed as many a billion skin cells a day, and up to 10% of those may carry on average four microbes per skin cell.

Not yet a Subscriber?

This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Cleanroom Technology.

Subscribe now Already a subscriber? Sign in here.

You may also like