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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. This makes it critical that the monitoring instruments and software implemented must be capable of generating reliable, timely results with demonstrable data integrity.

TSI: Reliable, Timely Results with Secure Data Integrity

  • No Loss of Data. TSI AeroTrak®+ Remote Particle Counters can buffer over half a year of one minute continuous particle sample results. When coupled with the reliable TSI FMS Software, no other system does more to prevent loss of data. 

  • 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 occurs.

  • Worry-Free VHP Resistant Sensors. TSI VHP resistant 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 Counter (a biofluorescent particle detector) offers the best of three worlds. An alternative and rapid microbiological testing method (ARMM) for viable air testing, it performs ISO compliant total particle counting, real-time viable particle detection, and sample capture to allow for the opportunity to identify microorganisms.

  • 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.

Compliant and Simple Cleanroom Classification

All TSI AeroTrak Portable Particle Counters are designed to simplify the cleanroom classification process per common standards including EU GMP Annex 1 and ISO 14644-1. This is done by either using the instrument's built-in reporting capabilities or utilizing the included TrakPro™ Lite Secure Software to generate high quality reports.

High flow rate instruments are available for rapid sampling of a full cubic meter of air.

Compliant and Simple Cleanroom Monitoring

TSI AeroTrak Portable Particle Counters and BioTrak Real-Time Viable Particle Counter [using biofluorescent particle counting (BFPC) technology] can operate with the included TrakPro Lite Secure Software in an optional mode that is specifically designed to meet ALCOA+ data integrity principles.

TSI FMS Software (with OPC UA Client/Server functionality) can also be seamlessly integrated with AeroTrak Portable Particle Counters and BioTrak Real-Time Viable Particle Counter, as well as AeroTrak+ Remote Particle Counters and environmental sensors, to centralize all particle counting data and to continuously monitor cleanrooms and isolators.

Read What the PEMM Group is Saying...

about how biofluorescent particle counting (BFPC) technology and BFPC detectors are helping address major industry concerns (risk managment, productivity and safety). Source: European Pharmaceutical Review

PEMM (Process and Environmental Monitoring Methods) group is a collaborative group comprised of leading pharma industry experts.

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