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Laser Particle Counters
Validation & Calibration
Supporting cleanroom maintenance and compliance
For particle counting accuracy, calibrate your laser particle counters with Thermo Scientific Count Controls
Accurate measurement of particulate matter is essential in cleanroom monitoring across pharmaceutical, life science, aerospace, defence, and semiconductor manufacturing as well as food and beverage environments where air, surface, or liquid contamination is a concern and requires diligent monitoring.
Thermo Scientific™ Count Controls provide a comprehensive solution for calibrating and validating laser particle counters to ensure accurate results. Our Count Controls enable users to validate the accuracy of their particle counters, regardless of the brand they are using. By using our solution, you can have confidence that your instrument is measuring particulate matter correctly, avoiding potentially misleading and inconsistent data that could lead to costly and time-consuming errors.
Our Count Controls have a diameter that can be traced back to the National Institute of Standards and Technology (NIST) and provide the necessary documentation and assurance required by quality control (QC) processes. They are designed to help maintain cleanrooms and ensure that they meet stringent protocols, including the ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-3:2019 standards. These standards involve the classification of air cleanliness by particle concentration, specifications for testing and monitoring to demonstrate ongoing compliance, and guidance on the instrumentation to be used for testing compliance with ISO 14644-1.
Our Count Controls are supplied as a low residue aqueous suspension, minimising background interference and allowing for precise insight into the dynamic range and calibration of the instrument.
Count Controls – applications and uses
- Instrument calibration and validation of particle counters using laser scatter, light scatter, light blockage, imaging, microscopy, and electrical resistance.
- QC checks for instrument problems and shifts in laser function, check the calibration curve shape, and more.
- Monitor for particulate matter in the manufacture of parenteral drugs and ophthalmic solutions.
3K/4K Series Particle Counter Standards
The Thermo Scientific 3K/4K Series Particle Counter Standards ensure accurate and convenient calibration of laser particle counters. This product line is specifically designed for immediate use in laser particle counters, reducing the need for time-consuming concentration adjustments.
- Suspensions of monodisperse polystyrene spheres for use in airborne or liquid particle dispersion systems
- Particle diameters traceable to the Standard Meter through NIST
- Accurately calibrates or checks performance of laser particle counters used in cleanrooms and other contamination monitoring applications
- Particles prepared as low residue aqueous suspensions for minimal background interference
PHARM-TROL Count Precision Size Standards
Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards.
- Ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification
- Data is documented for internal or customer audits by using a NIST™-traceable microsphere suspension with a known concentration
- Contains NIST™-traceable size standards with a measured particle count
- Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Ophthalmic Solutions)
- Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology
- Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration
COUNT-CAL Count Precision Size Standards
Minimise contamination by eliminating the need for serial dilutions and extensive sample handling with Thermo Scientific™ COUNT-CAL™ Count Precision Size Standards, a cost-effective, convenient and easy to use product for validating liquid particle counters.
Packaged in single-use bottles and intended to be sampled directly from the bottle, standards were developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP 788 and 789 (Particulate Matter in Injections and Particulate Matter in Ophthalmic Solutions).
Ready to use precision size standards are designed for regular use in liquid particle counters to verify instrument calibration before each use, assuring the reproducibility of the particle counter by permitting a continuous record of its performance using a NIST™ traceable microsphere suspension with a precise concentration.
- Polystyrene microspheres are suspended in an ultra-clean diluent
- Concentration is optimised for use in light obscuration particle counters and other low concentration counting applications
- Diameters are traceable to the Standard Meter through NIST
- CC10 and CC25 are ideal for USP 788 and 788 interim testing
- Includes a Certificate of Calibration and Traceability to NIST™, Particle counting protocol and Material Safety Data Sheet
Ezy-Cal Count Precision Size Standards
Meet the unique and demanding requirements of the contamination control laboratory in modern industries with Thermo Scientific™ Ezy-Cal™ Count Precision Size Standards, easy-to-use liquid particle count controls at 2000 particles per mL. Designed for regular use in liquid particle counters to verify instrument calibration before each use, standards assure reproducibility of the particle counter by permitting a continuous record of its performance using a NIST™-traceable microsphere suspension with a precise concentration.
- Ready-to-use (no dilution required) particle size standard for validating optical particle counters
- Magnetic stir bar included in each bottle for clean, convenient and direct sampling
- Aqueous suspension medium contains a combination of dispersing agents to keep particles from clumping or sticking to flow surfaces in the particle counter
- Particle diameters traceable to the Standard Meter through NIST
Validex Count Precision Size Standards
Validate the performance of liquid particle counters with Thermo Scientific™ Validex™ Count Precision Size Standards. Excellent for instrument calibration and verification in the drinking water industry and for low level liquid particle counting and calibration, standards contain NIST™-traceable polymer particles packaged in ultrapure water at concentrations ideal for use in validating the performance of liquid particle counters.
Particle counting in the drinking water industry has rapidly become an indispensable technology for optimising water quality. The majority of particle counters used in the drinking water industry operate on the principle of single particle light obscuration.
- Composition of suspension optimised to promote dispersion of particles
- Contains 500mL of suspension at a nominal concentration of 1000 particles per mL
- Stir bar included in the bottle to aid dispersion
- Certified concentration
- Ultraclean diluent
- No dilution required
- Sample directly from bottle to avoid contamination
- Larger volume for appropriate testing
Particle technology
Rely on Thermo Scientific bead solutions for calibration, immunoassays, flow cytometry, and particulate analysis. Our commitment to the world's leading clinical diagnostic labs, pharmaceutical firms, universities, and research institutions is built on a foundation of unmatched expertise in designing and manufacturing beads that deliver superior accuracy, consistent lot-to-lot reproducibility, high uniformity, and long-term stability.
Whether your application is lateral flow, slide agglutination tests and turbidimetric assay development, or particle characterisation, cell sorting and counting, food/agriculture, industrial, and more, please contact our Particle Technology staff to discuss your specific needs.
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