Bioburden testing determines the number of viable aerobic microorganisms that live on or in end products or raw materials which have not been sterilized. Bioburden testing is conducted in two parts: In the first, quantitative phase (microbial enumeration), the total number of aerobic microorganisms as well as the total yeast and mold count is determined. The second, qualitative phase (test for specified microorganisms) is designed to determine the presence or absence of specific microorganisms.
For quality control in manufacturing, bioburden testing of raw materials, water and end products has become a challenge. QC labs need to follow company guidelines which are driven by the stringent regulations of the pharmacopeias (Europe, US and Japan) while constantly optimizing laboratory workflow and delivering both reliable and consistent results. The relevant standards for the bioburden test (microbial limits test) have recently been harmonized for the US, Europe and Japan and are laid down in USP <61> and <62>, EP Chapter 2.6.12 and 2.6.13 and JP XV 1st Supplement, respectively.
