Contamination control / Particle counters

Particle Counters & Ventilation Test Instrument. GMP Provides solutions for cleanroom applications, helping customers ensure regulatory compliance, and improve quality. Key products include BioTrak™ Viable Real-Time Particle Counters, AeroTrak® Airborne Particle Counters, FMS Facility Monitoring Software and Ventilation Test Instrument. These products assist customers in monitoring and classifying Cleanrooms, and in finding the root cause of contamination events.

 

Airborne Particle counter.

Real -Time Viable Particle counter
An accurate real-time assessment of environmental microbial conditions. It’s the dividing line between knowing and hoping that your pharmaceutical microbial levels are under control.

The BioTrak™ Real-Time Viable Particle Counter from TSI features:

  • The most discriminating data available
  • Patented*, field-proven, Laser Induced Fluorescence (LIF technology)
  • ISO-21501-4 compliant particle counting
  • Integrated particle collection filter for offline analysis of optically analyzed particles

 

Non viable particle counter
The AEROTRAK line of Particle Counters, including handhelds, portables, and remotes, are designed to meet the rigid requirements for life science clean room applications. AEROTRAK Particle Counters comply with the stringent requirements set forth in ISO 21501-4. These particle counters are calibrated to NIST traceable PSLs using TSI’s world-class Classifier and Condensation Particle Counters, the recognized standard for particle measurements. Backed with TSI’s long-standing reputation for high quality and accuracy, AEROTRAK Particle Counters provide the best measurement and data to help keep your processes in control.

We GMP technical Solutions take immense pride in informing to be selected as Gold sales partner for TSI USA to sell service world class particle counters. We promote the range Airborne Particle Counter that includes:

  • Handheld Particle counter
  • Portable Particle Counter
  • Remote Particle Counter

 

Ventilation Test Instrument
Investigating, identifying and solving measurement problems allow you to accurately and reliably measure a wide variety of HVAC testing and balancing parameters that will have your building HVAC system operating at peak efficiency.

  • Air capture Hood
  • Air Velocity Meter
  • Air Velocity Transducer
  • Ductwork Leakage Tester
  • Micrometers
  • Rotating Vane Anemometer

 

Calibration Facility

GMP also provides onsite/offsite calibration Services for TSI make particle counter.
The calibration we perform according to ISO 21501-4. ISO 21501 describes a calibration and verification method for a light scattering airborne particle Counter (LSAPC).

 

BIOTRAK™ Real-Time Viable Particle Counter
The BIOTRAK™ Real-Time Viable Particle Counter offers best-in-class features and versatility in the exciting new field of real time airborne viable particle detection. The BIOTRAK particle counter detects total and viable particle counts in real time and incorporates TSI field proven, patented Laser Induced Fluorescence (LIF) technology to determine particle viability. TSI’s BIOTRAK Real-Time Viable Particle Counter combines viable particle detection, total particulate detection, and integrated particle collection functionality into a single portable instrument.

Model 9510-BD

Feature and Benefits

  • 0.5 to 25 µm size range
  • Up to six channels of simultaneous total and viable particle data
  • Patented Laser Induced Fluorescence viability detection
  • Integrated particle collection filter for off line speciation analysis
  • Full optical particle counter functionality
    • Complies with all requirements of ISO 21501-4
    • 1 CFM (28.3 L/min) sample flow rate
    • Intuitive icon driven touch screen Graphical User Interface
    • Recipe based storage and recall of sampling protocols
    • Reports for ISO-14644-1, EU GMP Annex 1, and FS209E
    • 10,000 sample record storage, 999 locations
    • Ethernet and USB outputs
    • Displays up to three environmental parameters
  • Stand-alone operation or integrate into a facility monitoring system
  • Stainless steel enclosure

 

Applications

  • Cleanroom Certification
  • Online monitoring
  • Trending of Biological Particulate levels
  • Process Improvement
  • Operator Training
  • Qualification Tool
  • Risk Management
  • Root cause investigations

 

Non viable particle counter

One of the most common environments that incorporate contamination control into its standards protocol is the clean room. There are many preventive procedures in place within the clean room environment. Certain areas in the clean room have more stringent measures than others. Places such as packaging areas, corridors, gowning rooms and transfer hatches incorporate strict contamination control measures in order to keep to the clean room standards. Semiconductor, hard disk drive, and flat panel manufacturers require extremely high levels of performance. Even a minor lapse in quality can result in severe economic loss. It is very important to precisely measure the environmental conditions and performance of vital manufacturing areas to ensure high yield of quality product. Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products.

 

Key features of TSI AEROTRAK™ Airborne Particle Counters:

  • One of the lightest portable Particle counters in the market currently.
  • AEROTRAK Particle Counters are fully compliant with ISO 21501-4.
  • Largest data buffer -10,000 records
  • AEROTRAK™ portable particle counters are compliant with FDA 21 CFR Part 11
  • These particle counters are calibrated to NIST traceable PSLs using TSI’s world-class Classifier and Condensation Particle Counters-the recognized standard for particle measurements.
  • AEROTRAK Particle Counters generate report for Federal standard FT3, Federal standard M3, ISO14644-1, EU GMP Annex 1.
  • Ethernet connection to integrate the AeroTrak into the real time FMS 5 monitoring system
  • The 100 LPM versions allow you to sample 1m3of air airs in just 10 minutes; shortening the time needed to perform ISO 14644-1 and EU GMP classifications.

 

TSI is the pioneer in contamination control & measuring products, and along with GMP it can offer wide range of clean room solutions.

Handheld Particle counter

The TSI AEROTRAK™ Handheld Particle Counters offer the most features and flexibility for customers interested in low cost and versatile particle contamination monitoring. Backed with a standard 2 year warranty and TSI commitment for superior service and support, there is no other particle counter on the market today with such features and benefits.

 

Portable Particle counter

The TSI AEROTRAK™ Portable Particle Counters offer the most features and flexibility for customers interested in manually monitoring particle contamination at high flow rates. These particle counters can be used as stand-alone portable counters or can be integrated into a facility monitoring system.

 

Remote Particle Counter

The TSI AEROTRAK™ Remote Particle Counters offer the most features and flexibility out of any remote particle counter on the market today. Integration is easy using either Ethernet (TCP/IP) or Serial Modbus RTU communications. The instrument can be powered over its Ethernet connection (Power-over-Ethernet) to simplify installation, or via a local power supply. Configuration can be done locally with a PC or via a web browser. These particle counters can also store up to 3,000 sample records providing data redundancy. The instrument reports up to 4 particle sizes simultaneously and other key information.

  • Monitoring and Verifying Clean rooms
  • Hospital Pharmacies & Surgery Suites
  • Medical Device Manufacturing & Packaging
  • Food / Beverage Manufacturing & Packaging
  • Clean room Laundries
  • Aerospace Assembly
  • Auto & Appliance Paint Booths
  • Particles in Injections
  • Wafer Manufacturer
  • Disk Drive Manufacturer
  • Operation Room Monitoring.
  • Particle Generation Testing
  • Water for Injection
  • Clean Booth & Bench Monitoring
  • HEPA Filter Leakage Testing
  • Cosmetic Manufacturing & Packaging
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