Monday, 4 November 2013

Optimal recovery of bioburden from pharmaceutical products

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

For those interested in reading the paper, please contact TimSandle.

Posted by Tim Sandle