Bioburden
testing is an important part of pharmaceutical microbiology and provides data
in relation to the quality of pharmaceutical products during manufacture.
Little guidance is provided in relation to test methodology, culture media and
incubation parameters. The quality control laboratory, therefore, needs to
establish the most appropriate method.
With
this in mind, Tim Sandle and colleagues have written a paper which outlines a
case study for the selection of incubation parameters for the bioburden
assessment of in-process samples using the Total Viable Count technique and
pour plate method.
While
the outcome of the experiment contained within the paper relates to a specific
set of processes, the approach taken can be used by other laboratories to compare
or to develop their test methods and techniques for bioburden determinations.
The
reference is:
Sandle,
T., Skinner, K. and Yeandle, E. (2013). Optimal conditions for the recovery of
bioburden from pharmaceutical processes: a case study, European Journal of Parenteral and Pharmaceutical Sciences, 18 (3):
84-91
Posted by Tim Sandle
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