Primary validation of the growth direct bioburden system and media

This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.

Bacterial colonies growing on culture plate medium


In 2015, Murphy and Schwedock1 published a paper outlining the statistics to be used to validate an RMM. Since that time, new versions of the US Pharmacopoeia (USP) and the EP have been published with updated statistics. The current EP 5.1.62 chapter has more clearly specified the requirement for suppliers of RMMs to supply the formal validation data obtained using their method. The analytical testing is well defined in the chapter; however, the statistical analysis is not as clear. The USP have made an obvious choice to focus on equivalence or non‑inferiority for most of the validation parameters but is less clear on the role of the supplier. It is the goal of this paper to describe the validation methods for bioburden test application performed using the Rapid Micro Biosystems Growth Direct (GD) system and associated consumables. Experimental data obtained has been analysed using statistical methods that are in line with the EP and USP.

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