A comprehensive new primary validation of the popular TSI BioTrak real-time viable particle counter from Validair has recently been completed to satisfy the demanding requirements of both users and regulators. In addition, the instrument now features enhanced detection algorithms that add important discrimination capabilities for mould spores, fungi and bacteria centred around specific requirements of pharma manufacturers.
The validation development is driven by updates to regulatory guidance for validating alternative and rapid microbial methods (ARMMs) in recent years based on empirical evidence collected as technological ARMM solutions gain acceptance. Prior to initiating testing, the specialist product team at TSI researched opportunities for improvement that would optimise the value of the new validation testing. With extensive quantities of data collected in the years since the BioTrak real-time viable particle counter was first introduced, a comprehensive review identified key opportunities to enhance the viability algorithm.
The latest enhancements provide improved detection of viable particles without a significant increase in false positives, which translates to the highest levels of user confidence that their aseptic environments are not putting their product at risk. New developments that improve the instrument’s detection and discrimination performance with mould spores, fungi and bacteria are also driven by identified user needs.
The product is a popular ARMM solution for viable testing of air in the pharma sector. All new TSI BioTrak instruments from Validair feature an enhanced algorithm supported by the new, more rigorous, primary validation. Existing instrument owners can also benefit from these changes through a firmware upgrade that Validair support engineers can perform on-site.