ABOUT US
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.
PHARMACEUTICAL ENVIRONMENTAL MONITORING TYPES
TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.
HOT PRODUCTS
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.
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.
CONTACT INFORMATION
TSI Incorporated
500 Cardigan Road
Shoreview, MN 55126
UNITED STATES
Phone: 800-777-8356
Contact: Sales
FEATURED ARTICLES
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![TSI]( "Improved Viable Particle Discrimination With Real-Time Viable Particle Counter")
A new algorithm developed by the BioTrak Real-Time Viable Particle Counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.
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![Vaccine manufactiring vials iStock-1292355769]( "Aseptic Environmental Monitoring For Vaccine Manufacturing")
To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.
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![TSI biotrak-filter-scanning]( "Real-Time Viable Particle Detection For Definitive Root Cause Investigation")
Investigations into viable air excursions are difficult to perform using traditional methods. Discover why a real-time viable particle counter is key to providing process improvement.
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![AeroTrak-Plus]( "Microbial Air Sampling: Physical And Biological Collection Efficiencies")
GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.
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03/04/20 Pharmaceutical Online Newsletter
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![cc-data-integrity-header-1200x628]( "TSI Announces Enhanced Data Integrity Capabilities For Particle Counters")
TSI Incorporated, manufacturer of real-time viable particle counters and airborne particle counters for contamination control monitoring, is pleased to announce enhanced data integrity capabilities for all AeroTrak Portable Airborne Particle Counters, AeroTrak 9306 Handheld Airborne Particle Counter and BioTrak Real-Time Viable Particle Counter.
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TSI introduces a new range of AeroTrak®+ Remote Airborne Particle Counters (APCs) for monitoring manufacturing cleanrooms. TSI is so confident about the performance of the new laser technology inside, that all models are covered by an industry-exclusive standard 5 year laser warranty.
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![The Case For A Facility Monitoring System]( "The Case For A Facility Monitoring System")
Facility monitoring software with OPC UA client/server functionality makes great business sense. Cleanroom monitoring leads to reduced waste, improved yield, product quality, and increased profits.
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![TSI biotrak-left]( "Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?")
Real-time viable particle monitoring instruments have been available for over five years. Learn in detail about this technology and how it is used to detect viable particles in real-time.
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Investigations of airborne viable excursions in cleanrooms using traditional techniques notoriously fail to identify a definitive root cause. No matter how extensive the investigation, due to the limitations of the traditional tools available, luck often plays a large role in actually identifying an elusive "smoking gun".
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![lifimage]( "Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?")
In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.
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![Microbial And Biological Decontamination Of Equipment Brings Peace Of Mind]( "Immediate Benefits Of Real-Time Microbial Monitoring")
Airborne microbial contamination is a serious concern for companies producing medicines and biotech products, and it must be addressed to ensure that products and people are kept safe.
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![Improve Your Facility Monitoring System To Comply With Regulatory Requirements]( "Improve Facility Monitoring Systems To Comply With Regulations")
A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime.
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The BioTrak Particle Counter instantly detects microbial contamination, a vast improvement over century-old culture-based methods.
VIDEOS
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![aas-video-150x100]( "Reduce Production Waste In Pharmaceutical Manufacturing")
Learn how cleanroom technicians can perform confident, reliable aseptic microbial monitoring in pharmaceutical manufacturing Grade A and B environments with external vacuum systems.
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![Bio-Trak Real-Time Viable Particle Counter 1]( "BioTrak Real-Time Viable Particle Counter Video")
Investigations of airborne viable excursions in cleanrooms using traditional techniques notoriously fail to identify a definitive root cause. What if this information were available in real-time when the contamination event occurred? This video introduces real-time viable particle monitoring and how it can quickly identify the source of a contamination.
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![real time microbial contamination info]( "Real-Time Information On Microbial Contamination In Pharma Cleanrooms")
The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.
