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Pharmaceutical Manufacturing

Putting patient safety first

Pharmaceutical Manufacturing

Putting Patient Safety First

Contaminated products pose an obvious health risk to patients. That is why pharmaceutical/life science companies are required to manufacture in controlled environments as part of their overall contamination control program. These environments must be monitored to assure control is maintained, making it critical that the monitoring instruments and software implemented must be capable of generating reliable, timely results with demonstrable data integrity.

TSI: Reliable, Timely Data You Can Trust

  • No Loss of Data. TSI AeroTrak®+ Remote Particle Counters (Model 6510 with integrated pump or Model 7510) can buffer 250,000 records. That’s over half a year of one minute sample results. When coupled with the reliable TSI FMS Software, no other system does more to prevent loss of data. 

  • Every Second Counts. Every Second Counts. When working with high value products, waiting for one minute to get a particle count may be too long. TSI AeroTrak+ Remote Particle Counters can monitor on a per second basis to alarm the instant an excursion occur.

  • Worry-Free VHP Resistant Sensors. VHP resistant TSI AeroTrak+ Remote Particle Counters are available for worry-free use in isolators or other environments that employ vaporized hydrogen peroxide for sanitization.

  • Long Laser Life. TSI AeroTrak+ Remote Particle Counters are designed for reliability and backed by a best-in-class 5 year laser warranty

  • The Future of Viable Monitoring is Now. TSI BioTrak® Real-Time Viable Particle Monitor offers the best of three worlds. It performs IS0 compliant total particle counting, real-time viable particle detection, and sample capture to allow for the opportunity to identify microorganisms.

Cleanroom Particle Monitoring is Simple

  • Cleanroom Classification. All TSI AeroTrak Portable Particle Counters are designed to simplify  the cleanroom classification process with built-in EU GMP Annex 1 and ISO 14644-1 reporting.  High-flow rate instruments are available for rapid sampling of a full cubic meter of air. 

  • Periodic Cleanroom Monitoring. TSI AeroTrak Portable Particle Counters can operate as standalone instruments or can be integrated with TSI FMS Software to centralize all particle counting data.

  • Continuous Monitoring of Cleanrooms and Isolators. TSI FMS Software (with OPC UA Client/Server functionality) seamlessly integrates a range of instruments, including TSI AeroTrak Portable Particle Counters, TSI AeroTrak+ Remote Particle Counters, and environmental sensors to continuously monitor cleanrooms and isolators.

  • Pharma 4.0 Ready. With best-in-class features, such as OPC UA Client/Server, distributed databases, and hot standby, TSI FMS Software is ready for Pharma 4.0 with  unparalleled flexibility and reliability to communicate and exchange data with different IT systems and software applications.

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