It is baffling that within the pharmaceutical industry, scientists still conduct tedious tasks like manual data entry and paper signatures, as they did 80 years ago. There is an urgent need to transition from traditional, manual, paper-based microbiology systems to automated digitised systems to overcome efficiency issues and human error. Ivan Muhvic, Field Validation Specialist, Rapid Micro Biosystems, introduced his company’s Growth Direct System as a potential solution.
From a regulatory viewpoint, many errors that regulators pick up on are related to integrity issues. The multiple requirements from different jurisdictions in the pharma world, like the EU standards, US FDA, and Japanese pharmacopeia, can confuse things for scientists. While there is a lot of overlap between them, the wording is often different and confusing, leading to a lack of harmonisation.
So, Rapid Micro Biosystems’ technology holds promise because the automated system addresses data integrity issues by logging all actions with user credentials, making results un-editable and undeletable. According to Muhvic, this ultimately helps clients avoid regulatory problems.
The system automates incubation, imaging, and colony counting of Petri dishes. This reduced manual errors and drastically diminished test turnaround times from the typical 5 -7 days. Robots manoeuvre cassettes rather than waiting until the end of a test is complete, and the machine automatically counts colonies as they grow in real time. Every four hours, an image is fed back to the machine, and the algorithm will calculate the number of microbial coliform units present.
Muhvic added that the system can be integrated with various lab management platforms, including LIMS, Lab Vantage, and SAP. This streamlines sample tracking and reporting through a bridge computer. Other features include remote monitoring options and robust cassette/label design. Muhvic briefly covered the practical benefits of these, such as reduced risk of sample loss and easier handling compared to traditional plates.
