A systematic approach for the evaluation, validation, and implementation of automated colony counting systems

Automated colony counting systems have been available for several years with varying degrees of automation. Sophisticated instruments are now increasingly used in microbiological laboratories of pharmaceutical quality control and, in addition to the colony counting device, they are now equipped with robotic systems performing the entire handling of the Petri dishes.

These systems mean the subjective evaluation of microbial enumeration tests by analysts is replaced with a more accurate and precise process, which leads to significant improvements to data integrity compliance. Automated systems can also enable cost reductions in the microbiological laboratory, e.g., by not requiring a second analyst's contemporaneous verification. They also allow the direct integration of count data into a Laboratory Information Management System, reducing hands-on times, costs per test, and preventing human errors caused by manual transcription.

Altogether, these instruments will lead to improved monitoring and assurance of the control of biopharmaceutical processes and manufacturing environments and shortened cycle times in the supply chain. Regulators are encouraging the biopharmaceutical industry to adopt these innovative systems.

However, there is no standard approach taken when using these automated systems.

This paper describes a systematic nine-step approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of their numerous benefits.