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

• Complete Environmental Monitoring. TSI offers environmental monitoring systems that integrate total particle counting, viable particle monitoring (active air sampling) as well as temperature, pressure and humidity. Everything you need to verify appropriate environmental conditions for your aseptic process.

• 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 and VHP resistant AeroTrak Remote Particle Counters with Integrated Pumps 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

• Future of Compendial and Alternative Viable Monitoring. TSI offers system integrated AeroTrak+ Remote Active Air Sampler specifically designed for aseptic manufacturing lines. To go beyond compendial methods, the BioTrak™ Real-Time Viable Particle Counter (a biofluorescent particle detector that meets EU GMP Annex 1 requirements) offers continuous sampling without interventions. An alternative and rapid microbial testing method (ARMM) for viable air testing, it performs ISO compliant total particle counting and real-time viable particle detection.

• 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, AeroTrak+ Remote Active Air Sampler, and environmental sensors, to centralize all particle counting data and to continuously monitor cleanrooms and isolators.