Real-Time Viable Particle Counter

The BioTrak™ Real-Time Viable Particle Counter offers a superior solution for pharmaceutical environmental monitoring by providing real-time biofluorescent particle detection and sample capture capability. Its ability to differentiate between viable and inert particles ensures precise, reliable data, which is crucial for effective monitoring in aseptic environments. With its 21 CFR Part 11 compliance, this particle counter also guarantees data integrity, meeting strict regulatory standards. It can deployed for continuous monitoring, periodic testing, rapid contamination source identification, and room release, making it invaluable for routine environmental monitoring and risk assessment under GMP guidelines.

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BioTrak Real-Time Viable Particle Counter

Bietet eine Echtzeit-Zählung von gesamt- und lebensfähigen Partikeln in der pharmazeutischen...

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Culture-based methods remain essential in GMP environmental monitoring, but they do not provide immediate feedback. TSI real-time viable particle counters add a complementary capability by indicating viable bioaerosol presence during operations. This helps teams respond sooner, narrow investigations, and focus corrective actions.

Key applications include:

  • Continuous monitoring in Grade A/B areas to support situational awareness.
  • Early indication of events that warrant additional sampling or process checks.
  • Trending viable signals alongside nonviable particles and process data to refine risk assessments.
  • Supporting investigations during interventions, equipment changes, or atypical production runs.

Real-time viable data can be used alongside active air sampling and settle plates. When an event occurs, teams can capture culture-based samples for identification and confirmation while also using immediate signals to adjust activities and limit potential impact. Over time, trend analysis helps identify recurring patterns that guide procedural updates and training.

TSI instruments are designed to fit into cleanroom environments and integrate with monitoring systems for centralized visibility and reporting. Data handling supports traceability and collaboration across quality, operations, and engineering. By adding real-time viable insight, life sciences organizations can enhance contamination control strategies, respond more effectively to excursions, and support consistent decision-making across production.


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