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Pharmaceutical Manufacturing

Putting patient safety first

Pharmaceutical Manufacturing

Putting Patient Safety First

Patient safety is paramount in aseptic manufacturing. Airborne particle counters and facility monitoring systems must be designed to detect environmental contaminants to ensure pharmaceutical manufacturing process control. Demonstrated compliance with use of a facility monitoring system and high flow rate particle counter provides reliable results and trusted data integrity.

TSI: Data You Can Trust

  • Efficient Pharmaceutical Cleanroom Classification. High-flow rate instruments enable rapid classification of a pharmaceutical cleanroom. TSI AeroTrak® Particle Counters guide you through classification to almost any industry standard, including EU GMP Annex 1 and ISO 14644-1. 

  • Monitor Particle Sizes That Matter. 0.5 μm and 5 μm AeroTrak Remote Particle Counters are specially designed to count particles per pharmaceutical regulatory good manufacturing practices (GMP).

  • Worry-Free VHP Resistant Sensors. TSI AeroTrak Remote Particle Counters are suited specific for use in pharmaceutical monitoring applications. They are available with VHP resistance so they can be efficiently cleaned without worry.

  • The Future of Viable Monitoring is Now. TSI BioTrak® Real-Time Viable Particle Monitor offers the best of three worlds: IS0 compliant total particle counting, real-time viable particle detection, and sample capture to support traditional or rapid growth-based sampling methods.

Cleanroom Particle Monitoring is Simple

  • Pharmaceutical Cleanroom Classification. All TSI AeroTrak Portable Particle Counters are designed to simplify and speed up the pharmaceutical cleanroom classification process. With EU GMP Annex 1 and ISO 14644-1 reporting built in, TSI particle counting instruments are simple to setup and easy to use. 

  • Periodic Monitoring of a Pharmaceutical Cleanroom. TSI AeroTrak Portable Particle Counters operate as standalone instruments or integrated with a facility monitoring system for efficient periodic monitoring in a pharmaceutical manufacturing space.

  • 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. With best in class features, such as OPC UA Client/Server, distributed databases, and hot standby, TSI FMS Software offers the unparalleled flexibility and reliability for different IT systems and software applications to communicate and exchange data. This data can then be used to continuously monitor a pharmaceutical manufacturing space.

Quickly identify what cleanroom particle counter you need

Model Flow Rate Particle Size Range With Integrated Pump
Cleanroom Remote Particle Counters
6510* 1 CFM (28.3 LPM) ±5% accuracy 0.5 to 25.0 μm X
7510* 1 CFM (28.3 LPM) ±5% accuracy 0.5 to 25.0 µm  
Cleanroom Portable Particle Counters
9350 1.77 CFM (50 LPM) ±5% accuracy 9350-02, 9350-03: 0.3 to 25.0 µm  
9500 3.53 CFM (100 LPM) ±5% accuracy 0.5 to 25.0 µm  
9510 1 CFM (28.3 LPM) ±5% accuracy 9510-02, 9510: 0.5 to 25.0 µm  
9550 1.77 CFM (50 LPM) ±5% accuracy 9550-02: 0.5 to 25.0 µm  
Cleanroom Handheld Particle Counters
9303 0.1 CFM (2.83 LPM) 0.3 to 25.0 µm  
9306 0.1 CFM (2.83 LPM) ±5% accuracy 0.3 to 25.0 µm  

*VHP-resistant models available

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