Monday, 29 July 2019

Contamination control hot topics


There are a number of challenges facing pharmaceutical and biopharmaceutical companies in relation to controlling contamination in their facilities. To address some of these issues American Pharmaceutical Review recently hosted a contamination control roundtable.

Taking part were: Tony Cundell, Paula Peacos, Tim Sandle and Jeanne Moldenhauer.

Here is an extract from Tim Sandle:

“The problems will vary between different facilities, and these will center on the different sources of contamination in relation to people, air, water, transfer of items, equipment cleanliness, and bioburden of starting materials. The most difficult challenges are invariably around people: how personnel behave in cleanrooms, how they are gowned, and whether they follow the correct procedures. Although the regulations around personnel have largely remained unchanged, its noticeable that the number of warning letters and other regulatory citations have increased. The reason for this must rest with training, knowledge and with time (in terms of allowing operators sufficient time to carry out their duties and to clean and disinfect effectively).

“Keeping track of data is also a challenge. With large facilities in particular, assessing microbial and particulate trends remains important so that appropriate actions can be taken promptly. Furthermore, it is important to understand when the process is leaning out of control, to enable personnel to be alerted to a potential change in the process.”

The reference is:

Cundell, T., Peacos, P., Sandle, T. and Moldenhauer, J. (2019) Contamination Control Roundtable, American Pharmaceutical Review, 22 (3): 44-47

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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