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Abstract  

Traditional microbiological techniques have been used for well over a century as the basis for contamination testing of pharmaceutical products and processes. With a more recent industry focus on faster product release and concerns around integrity of data, new technologies have been implemented to detect and enumerate organisms faster and provide paperless processes to minimize data integrity issues. Automated colony counters, that perform both the incubation and enumeration, have recently been implemented for quality control (QC) laboratory analytical processes, supporting a cGMP environment. This article summarizes the findings of eight companies demonstrating their qualification of an automated colony counter technology to perform most microbial tests required for QC, environmental monitoring, bioburden, bulk drug substance and water testing.

Authors: Hans Joachim Anders, Daniel Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah, and David L. Jones