The Rapid Micro Blog

Our blog will keep you informed of new and noteworthy technologies, reviews of recent publications and presentations, upcoming conferences and training events, and what's changing in the rapid and alternative microbiological methods world.

Automating the Micro QC Lab (Part 4)

Over the last few months, Steve Delity, President and CEO of Rapid Micro Biosystems, has provided his insights into the benefits of automation in the pharmaceutical microbiology lab. In my fourth and final blog on this subject, I asked Steve to briefly comment on the impact automation may have on validation.

Michael - Anyone who has attempted to validate a rapid solution knows the hurdles that must be overcome. Should companies be concerned that automation adds another level of complexity to the validation?

Steve – Not necessarily. In actuality, this could just be the opposite. A rapid method solution like ours or others in the market can greatly simplify the validation process, as automation could remove a number of validation performance requirements that other alternative methods might require. Additionally, automated methods that are based on compendial testing may also simplify this process. For most compendial microbiology methods, we utilize a certain sample size, media, incubation time and temperature and acceptance limits. Using a rapid method that has similar (or the same) testing elements will be straightforward to validate, since the difference is the automation. Methods that deviate and require different or additional steps may introduce variables and risk factors that will need to be addressed in the validation program.

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