The pharmacopoeia methods for microbiological purity has to be verified to show that the methods are capable of detecting microorganisms in the sample. The tests are listed in section 4 in Ph. Eur 2.6.12 and USP <61> ”Suitability of the counting method ”, and in section 3 in Ph. Eur. 2.6.13 and USP <62> ”Suitability of the test”. A suitability test is a recovery study and is performed by detection of up to 5 different types of microorganisms added to the sample. If the sample has antimicrobial activity, dilution, adding neutralising components, membrane filtration or other methods are used to neutralise the sample. This is to ensure a true picture of the content of viable microorganisms in the sample.
We perform suitability tests and validation of already existing methods, as well as developing and validating new methods for neutralising antimicrobial activity.
We are more than happy to develop and validate new methods of cell counts and identification of microorganisms according to ICH guidelines. A validation may include examination of the following parameters: