Real-time viable particle counter for pharmaceutical manufacturing
Ensure real-time monitoring of airborne viable particles in aseptic environments with advanced biofluorescent detection, minimizing contamination risks and enhancing process understanding for pharmaceutical manufacturers focused on safety and compliance.
The BioTrak Model 9510-BD from TSI is a cutting-edge viable particle counter designed for continuous, automated monitoring in aseptic environments. Leveraging biofluorescent particle detection, it distinguishes viable from inert particles, ensuring real-time monitoring of vital environments, such as pharmaceutical and biopharmaceutical production facilities, with exceptional precision. Particularly beneficial for vaccine manufacturing and sterile product production, it enhances environmental monitoring by reducing the need for aseptic interventions and supporting root cause investigations.
Operating with a 1 CFM (28.3 L/min) sample flow rate, the BioTrak integrates seamlessly into your current facility monitoring systems using the TSIFMS Software for automated data collection and analysis. The system supports compliance with GMP regulations by maintaining data integrity in accordance with 21 CFR Part 11 standards, and is further supported by the ALCOA+ principles in Data Integrity Mode. The standalone capability aids in rapid contamination source identification, room release, and risk assessment, while its stainless steel enclosure and HEPA-filtered exhaust ensure minimal maintenance and robust operation.
Benefits
- Enhances contamination control by providing real-time viable particle data.
- Reduces operational risk with continuous, automated environmental monitoring.
- Simplifies compliance with EU GMP Annex 1 standards for sterile manufacturing.
- Minimizes manual intervention, fostering safer aseptic processes.
- Ensures data accuracy and integrity in adherence to regulatory requirements.
- Applications
- Vaccine manufacturing,Sterile product production,Aseptic environments,Pharmaceutical microbiology,Biopharmaceuticals,Environmental monitoring,Pharmaceutical manufacturing
- End products
- Antibiotic ampoules,Lyophilized pharmaceuticals,Aseptically filled syringes,Monoclonal antibodies,Sterile iv fluids,Parenteral nutrition solutions,Ophthalmic solutions,Protein therapies,Live attenuated vaccines,Sterile injectable medications
- Steps before
- Air Sampling,Environmental Monitoring Setup
- Steps after
- Data Analysis,Root Cause Investigation,Room Release,Risk Assessment
- Input ingredients
- air samples,viable particles,inert particles,microorganisms
- Output ingredients
- viable particle counts,total particle counts,sampled microorganisms for identification,real-time data,contamination sources
- Detection Type
- Biofluorescent Particle Counting (BFPC)
- Sample Flow Rate
- 1 CFM (28.3 L/min)
- Particle Counting
- Viable and Total Particles
- Compliance
- ISO 21501-4
- Data Integrity
- 21 CFR Part 11 capable
- Automation
- Fully Automated Process
- Interface
- Touch Screen Graphical User Interface
- Automation level
- Fully automated
- Batch vs. continuous operation
- Continuous automated monitoring
- CIP/SIP
- Not required
- Changeover time
- N/A
- Corrosive resistance (e.g. acids)
- Stainless Steel
- Biological compatibility
- Pharmaceutical grade
- Cleanability
- HEPA filtered exhaust
- ISO 21501-4
- Complies with all requirements
- EU GMP Annex 1
- Meets Requirements
- 21 CFR Part 11
- Capable
- Data Integrity Mode per ALCOA+ principles
- Designed to meet GMP requirements
- Sample flow rate
- 1 CFM (28.3 L/min)
- Enclosure material
- Stainless steel
- Exhaust
- HEPA filtered
- Interface
- Intuitive icon driven touch screen
- Size
- 0
- Weight
- 0
- Footprint
- 0
- Integration with software
- TSIFMS Software,TSITrakPro™ Lite Secure Software
- Data collection mode
- Data Integrity Mode
- Touch screen interface
- Icon driven GUI
- Enclosure
- Stainless steel
- Market info