Microbial colonies have traditionally been observed on agar media. This is sometimes aided with various forms of magnification and often uses an electronic colony-counting pen to mark colonies.

As we know, human counting is subject to error, which can be costly and undermine confidence in lab operations, whilst reported values may also contain human errors during transcription. Health authorities may see these issues as signs of data integrity problems.

Automated colony counting systems are one option to help overcome these challenges. A new article by BioPhorum’s Alternative and Rapid Microbial Methods (ARMM) team explores this area and discusses how these systems can reduce or eliminate sources of human error, provide faster and more precise detection of microbial colonies, and allow greater control of data, data integrity and data security.

Currently, there is no standard approach taken when implementing these automated systems. A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems describes a systematic nine-step approach for the evaluation, equipment qualification, and deployment of automated colony counting systems. It uses the general framework previously published by the team for evaluating and implementing alternative and rapid microbiological methods.

The paper includes comprehensive tables that detail a comparison of candidates for automated colony counting systems (using mandatory core requirements and application-specific requirements), financial business case considerations, and a decision-making matrix (to be completed by the end-user). It was published in the PDA Journal of Pharmaceutical Science and Technology in March 2022. 

Sven Deutschmann, Head of Global ASAT “Adventitious Agent Testing & Alternative Microbiological Methods” at Roche and the paper’s lead author, said, “Using a systematic approach for the evaluation, validation, and implementation of automated colony counting systems is beneficial to all involved in the process. The preparation of this paper was more time-consuming and took longer than originally planned, but in the end, with great teamwork, we were able to describe a standardized process that can be applied by peers.”