New detection functionality for mould spores, fungi & bacteria for BioTrak
With the BioTrak Real-Time Viable Particle Counter already considered to be the pharma industry’s leading technology-based Alternative & Rapid Microbial Method (ARMM) for testing and continuous monitoring of air for viable particles, it's great news to see the addition of new detection functionality.
Mould, fungi & bacteria
The latest BioTrak enhancements that add new functionality and performance for the detection and discrimination of mould spores, fungi and bacteria originated from a development project that was entirely driven by identified user needs through some very close collaborations with pharma organisations. We can’t yet say who those collaborating users are.
New primary validation
A new, more rigorous and very comprehensive primary validation fully satisfies the needs of both BioTrak users and the regulatory authorities. That part of the development by the TSI expert team was driven by recent updates to the regulatory guidance for validating Alternative & Rapid Microbial Methods (ARMMs). It was based on sound empirical knowledge gleaned from years of evidence collected as this exemplary technological ARMM solution gained acceptance in world markets.