TSI serves the global pharmaceutical manufacturing market by providing trusted measurements in world class cleanrooms. Whether you periodically classify your clean areas or monitor them per your contamination control strategy, TSI particle counting instruments are here to help.

Now available, the Aerotrak™+ Portable Particle Counter A100 Series is specifically engineered for you to make your job easy, providing what you've been asking for in a portable particle counter, including:

  • Easy compliance — EU GMP Annex 1 (2022 and 2008), ISO 14644-1:2015, and China GMP
  • Data integrity — based on ALCOA+ principles
  • Intuitive GUI — requires no manuals to operate, significantly reducing the chance for user error and simplifying the sampling process
  • Communication options

The TSI BioTrak Real-Time Viable Particle Counter, a bio-fluorescent particle counter (BFPC), is the industry referenced instrument for real-time viable air and total particulate testing of pharmaceutical manufacturing environments. This instrument is your solution for meeting Annex 1 requirements for continuous viable air testing in Grade A areas to increase process understanding and reduce risk.

Industry trusted TSI FMS Software incorporates TSI particle counters, environmental sensors, real-time alarms and automated data collection. All work seamlessly as a complete system to assure easy FDA 21 CFR part 11 compliance and the highest level of data integrity. The continuous monitoring capabilities of aseptic processes reduces your risk by eliminating environmental monitoring (EM) interventions and improving quality through better process understanding.

With headquarters based in the U.S. and field offices throughout Europe and Asia, TSI has established a leading worldwide presence in the markets we serve.


AeroTrak Portables A100 Series

TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.

FMS/BioTrak/Portable/Remote/Environmental Sensors


Flow Rate 1 CFM (28.3 LPM) - 3.5 CFM (100 LPM) / Channel Sizes 0.3 µm to 10 µm,(6) user selectable channels.

What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

AeroTrak Remote Particle Counters with Integrated Pump are ideal for use in any GMP-controlled area where continuous particulate and environmental monitoring is required. AeroTrak Remote Particle Counter Models 6310, 6510 and the vaporized hydrogen peroxide (VHP)-resistant 6510-VHP have the features needed for seamless integration.

TSI AeroTrak+ Remote Particle Counters offer cleanroom professionals top-notch reliability and no-hassle operation in measuring a wide range of particle sizes, including a 6-channel model with upper size threshold of 25 µm. 

A widely used method to inactivate bio-contamination on surfaces in GMP controlled areas is sporicidal gassing using vaporized hydrogen peroxide (VHP). This decontamination process uses a free radical reaction to kill microorganisms on surfaces.

Provides confident and reliable aseptic microbial monitoring in pharmaceutical manufacturing Grade A and B environments with external vacuum systems.

The TSI AeroTrak 9303 Handheld Particle Counter offers the most features and flexibility for customers interested in a low cost and versatile handheld particle counter. The Model 9303 features a sturdy yet lightweight high-impact injection-molded plastic design for easy handling. The instrument is easy to configure using an intuitive keypad. The internal memory can store up to 1,500 sample records of particle count data which can be conveniently viewed on screen or downloaded using a USB port.

The TSI AEROTRAK 9306 Handheld Particle Counter offers the most features and flexibility for customers interested in versatile handheld particle contamination monitoring. The Model 9306 features an ergonomic handle with thumb controls, for easy one-hand operation.

TSI FMS system is an advanced, reliable and user-friendly monitoring software suite that has a true open architecture supporting multiple instrument inputs from any manufacturer.

Real-time airborne viable particle detection is challenging. TSI BioTrak Real-Time Viable Particle Counters provide confidence in instant detection and identification of viable particles, relying on the best particle discrimination technology available. 

TSI’s Continuous Monitoring Systems provide a complete solution to monitor your cleanrooms.

Most Continuous Monitoring Systems, in addition to FMS Software and AeroTrak Remote Particle Counters, include additional environmental sensors and interface devices.  FMS has the capability to interface with almost any environmental sensor from most manufacturers.  And, since FMS is so flexible, we can write additional drivers for your specific application.


TSI Incorporated

500 Cardigan Road

Shoreview, MN 55126


Phone: 800-777-8356

Contact: Sales