Tim
Sandle has written an article for European Pharmaceutical Review about
improving assurance in relation to microbial bioburden assessments. This
relates to the use of biocontainer bags, designed to reduce the chance of false
positives occurring.
Assessment
of microbial levels in (and on) samples is an important part of pharmaceutical
process control. Samples are drawn from intermediate product at defined stages
(ideally based on risk assessment) and these allow for the microbial levels to
be tracked from upstream processing to downstream processing (with an
expectation that the microbial levels decrease, or at least remain unchanged
provided they are below an acceptable action level). For aseptically products,
European guidelines require a certain bioburden to be met at the point that a
bulk product passes through a sterilising grade filter.
Due
to the relatively low specification – of 10 CFU/100mL – pharmaceutical
manufacturers need to ensure that false positive results are avoided (as might
arise from extraneous environmental contamination). False positives can result
in batch rejection. A key innovation, in recent years, is the biocontainer
sampling bag. This item of irradiated plastic is in keeping with moves towards
single use, sterile processing technology.
The
article examines the importance of bioburden testing, particularly in relation
to aseptically filled products, together with the most important criteria for
sampling bags.
Sandle,
T. (2016) Improving microbiological assurance for bioburden tests, European Pharmaceutical Review, 21 (3):
41-44
Posted by Dr. Tim Sandle
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