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Contamination Control - Life Science Applications

Contamination Control - Life Science Applications

Contamination Control - Life Science Applications

Product catalog summary
Regulatory Compliance
Pharmaceutical companies, medical device manufacturers, biotech companies, and healthcare facilities must adhere to strict regulations such as FDA Aseptic Guidelines and EU GMP Annex 1, classified under ISO 14644-1 standards. These regulations ensure safety and consistency in product manufacturing, storage, and testing.
Patient Safety
Manufacturing sterile products requires minimizing particle and microbiological contamination risks. TSI’s AeroTrak® Particle Counters and FMS 5 software monitor critical environments for particle contamination, temperature, humidity, and pressure, ensuring patient safety and regulatory compliance.
Process Control
TSI’s FMS software supports the US FDA Process Analytical Technology (PAT) initiative by identifying process weaknesses and implementing improvements. It provides real-time data collection for immediate response to out-of-specification events, aiding root cause investigations.
TSI’s Leadership in Particle Counting
TSI has been a leader in particle measurement for over 40 years, offering solutions for filter testing, atmospheric studies, clean room certification, and more. AeroTrak® Particle Counters meet ISO 21501-4 standards and are calibrated to NIST traceable PSLs.
Certification and Monitoring
AeroTrak Portable Particle Counters simplify clean area certification and monitoring with an icon-driven interface and secure data output. FMS 5 software integrates with AeroTrak counters for comprehensive facility monitoring, ensuring compliance with 21 CFR part 11.
AeroTrak Portable and Handheld Particle Counters
Portable counters offer various models for different sampling needs, featuring easy transport, extensive data storage, and pass/fail reporting. Handheld counters are ideal for identifying contamination sources and conducting investigations, with features like integrated handles and touch screens.
Continuous Monitoring with AeroTrak Remote Particle Counters
These counters provide continuous data streams integrated into FMS 5, ensuring process monitoring with data redundancy and easy configuration. They support Ethernet and Modbus RTU communications.
FMS 5 Facility Monitoring Software
FMS 5 is designed for compliance with EU GMP Annex 1 and FDA cGMP, offering secure data archiving, system security, and integration with various sensors. It includes redundancy features and alarm options for timely notifications.
Validation and Compliance
TSI provides validation lifecycle documentation based on ISPE GAMP® guidelines, including specifications and qualification tests, ensuring compliance in regulated environments.
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Catalog excerpts

Contamination Control - Life Science Applications-1

CONTAMINATION CONTROL FOR LIFE SCIENCE APPLICATIONS UNDERSTANDING, ACCELERATED

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Contamination Control - Life Science Applications-2

TSI SETS THE STANDARD FOR PARTICLE COUNTING Regulatory Compliance Patient Safety Process Control Pharmaceutical companies, medical device The manufacture of sterile products has special Continuous improvement tools such as TSI’s manufacturers, biotech companies, healthcare requirements to minimize the risk of particle FMS software, are an important part of the facilities and other regulated organizations are and microbiological contamination. Whether US FDA Process Analytical Technology (PAT) subject to a variety of laws and regulations manufacturing pharmaceutical drugs or medical initiative....

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Contamination Control - Life Science Applications-3

For over 40 years, TSI has been a recognized leader in accurate particle measurements. TSI is considered the leader in aerosol and particle instrumentation for many applications, including: +Filter testing + Atmospheric and climate studies +Ambient air monitoring +Nanoparticle measurements +Dust monitoring +Respirator fit testing +Engine emissions +Aerosol research +Clean room certification +Biodetection AeroTrak® Particle Counters - Where Research meets Reality The AeroTrak® line of particle counters, including handhelds, portables, and remotes, are designed to meet the rigid...

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Contamination Control - Life Science Applications-4

LIFE SCIENCE CERTIFICATION SOLUTION AEROTRAK PORTABLE PARTICLE COUNTERS TSI offers a complete line of Portable Particle Counters, including + Lightest products on the market, making it easy to transport from allows you to sample 1 m3 of air in just 10 minutes, shortening the time needed to perform ISO 14644-1 and EU GMP classifications. + Most sample points (10,000) and locations (999) available, allowing Professional certifiers prefer AeroTrak’s easy icon-driven touch you to store more information in the instrument screen interface when measured against comparable products. + Easy set-up and...

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Contamination Control - Life Science Applications-5

ISO 21501-4 Compliant TSI’s AeroTrak Particle Counters are fully ISO 21501-4 compliant, ensuring accurate and repeatable measurements. Classify clean rooms with confidence using products from TSI. AEROTRAK HANDHELD PARTICLE COUNTERS TSI’s Handheld Particle Counters are an excellent choice for tracking down particle contamination sources, classifying clean areas, looking for filter leaks, and conducting IAQ investigations. When used as survey tools, these products are a great place to start when looking for early identification of problem areas, helping you save time and money. The Model 9303...

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Contamination Control - Life Science Applications-6

ENSURE COMPLIANCE AND RELIABILITY WITH CONTINUOUS MONITORING AEROTRAK REMOTE PARTICLE COUNTERS ensures secure, tamper proof data archiving and reporting. System security is easily configurable. User groups allow TSI’s AeroTrak Remote Particle Counters provide a continuous stream users and managers appropriate levels of system access. of data that integrates directly into TSI’s FMS 5. These particle counters Open architecture makes it easy to integrate any sensor with standard can easily be mounted in critical locations to ensure your processes are outputs. This includes TSI’s AeroTrak Particle...

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Contamination Control - Life Science Applications-7

TSI’S CONTINUOUS MONITORING SYSTEM Alarm Beacon Main Database Temp/RH Dedicated or Corporate LAN Differential Pressure View Client View Client Mirror Database Email Alerts and SMS (text) Alerts AeroTrak Remote Particle Counters AeroTrak Portable Particle Counters

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All models, except Model 9303, communicate via modbus RTU • = Feature of Instrument + = Optional accessories available x = Specify at Time of Order AccuBalance, AeroTrak, VelociCalc, TSI, and the TSI logo are registered trademarks, and DP-Calc and TrakPro are trademarks of TSI Incorporated. TSI Incorporated - Visit our website www.tsi.com for more information.

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