Measuring equipment expert TSI has introduced a new implementation roadmap to support pharmaceutical manufacturers adopting alternative microbiological methods for Grade A environmental monitoring.
The company is a manufacturer of precision measurement and monitoring instruments for applications including cleanroom environmental monitoring, indoor air quality and aerosol research.
The newly launched BioTrak Biofluorescent Particle Counter Implementation Roadmap provides a structured framework covering the implementation process from initial project planning through to routine use.
The roadmap is based on experience from real-world installations and is intended to help cleanroom teams manage the practical and compliance requirements associated with introducing an alternative monitoring method.
Published in 2022, EU GMP Annex 1 explicitly encourages facilities to consider and validate alternative/rapid methods within their Contamination Control Strategy (CCS), and this roadmap aims to help companies achieve this.
Four-phase implementation for the roadmap
The roadmap is divided into four stages: Project Initiation, System Design, Validation and Routine Use.
TSI said resources and guidance are available throughout each phase, with the framework designed to address implementation challenges in pharmaceutical cleanroom environments.
Grade A environmental monitoring is a tightly regulated part of pharmaceutical manufacturing, with alternative microbiological methods increasingly being considered as manufacturers seek different approaches to contamination monitoring.
The BioTrak BFPC uses biofluorescence to provide real-time viable particle data and is positioned by TSI as an alternative to conventional active and passive air sampling in Grade A environments.
The roadmap covers project initiation, system design, validation and routine use, with guidance intended to support manufacturers through each stage of implementation.
"We built this roadmap from lessons learned in actual installations, so professionals have a proven framework at every phase. Our goal is to help teams reduce implementation complexity, support their compliance efforts, and move forward with real confidence,” said Ketan Mehta, Vice President of Sales and Marketing at TSI.
The company said the framework is intended to reduce the complexity of implementation and support manufacturers through the different stages of adopting the technology.
Other recent work by TSI
The move follows TSI’s earlier launch of its Nano LPM System for advanced semiconductor manufacturing, extending the company’s focus on real-time monitoring across critical cleanroom environments.
The roadmap also builds on TSI’s recent integration of its OmniCount PWCPC Model 3001 with the OmniTrak platform, enabling synchronised, real-time ultra-fine particle monitoring across multiple locations.
