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

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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

• Reduce or eliminate interventions in Grade A
• Achieve truly continuous viable monitoring
• Accelerate investigations with real-time data
• Meets Annex 1
• Watch video > | Review must ready industry published papers >

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