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Pharmaceuticals | Life Sciences

Contamination Control Instruments and Systems for Compliance

Meeting easy compliance for:

  • Global Good Manufacturing Practices
    • Annex 1 (EU, PIC/S, WHO): Manufacture of Sterile Medicinal Products
    • FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing
  • ISO 14644-1:2015, 14644-2:2015 & 21501-4:2018

TSI Airborne Particle Counters — Confident Results Matter

  • Models for every pharmaceutical environment and application
  • ALCOA+ data integrity principles for no-hassle 21 CFR Part 11 compliance
  • Leading the way in real-time viable particle detection

BioTrak™ Real-Time Viable Particle Counter (a biofluorescent particle counter) — The Future of Viable Monitoring

AeroTrak+ Remote Particle Counters — Ultra-Reliable Data Collection

  • Protect against network failures with six months of data storage
  • Worry-free cleaning with sealed inlets and VHP resistant options
  • Flexible environmental monitoring system with Wi-Fi® communication
  • Unmatched 5 year laser warranty

AeroTrak Remote Particle Counters with Pump 

AeroTrak Handheld Particle Counter

AeroTrak Portable Particle Counters

  • Different sample modes for monitoring, classifying, and root cause investigation
  • Built-in monitoring and classification reports
  • Unmatched 5 year laser warranty
  • Makes Annex 1 compliance easy — Read blog >

 AeroTrak+ Remote Active Air Sampler for Aseptic Environments

  • Intermittent sampling improves knowledge of conditions during a production run without interventions
  • Protect against network failures with local data storage
  • Watch video >

Integrated Environmental Monitoring Probes
 

TSI Facility Monitoring Software — Reliable Monitoring Systems

  • No single point of failure
  • Data available where and when you need it
  • Easily scalable
  • Pharma 4.0 ready — communication via OPC UA Client/Serverr

Monitor: Data Collection

  • Fault-tolerant design
  • Protects against network failures
  • Hot-standby options

Client: Interface

  • Turn data into knowledge with alarming, reports, and trending
  • Does not effect monitor or database functions
  • Multiple clients possible

Database: Secure Storage

  • Valuable data is safe and secure
  • Redundancy is standard with a mirror database
  • SQL for high availability and fast access