Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards

Document the reproducibility of a particle counter by permitting a continuous record of its performance.

Catalog Number	Mfr. No.	Diameter (Metric)	Quantity
09-980-236	Thermo Scientific™ CSBX	15 μm	20 x 25 mL Bottles
09-980-235	Thermo Scientific™ CSPK	15.0 ±0.2 μm	6 x 25 mL Bottles

Description

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.

Features:

• 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 Opthalmic 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

Specifications

• Concentration: 3800 particles/mL ± 15%
• Color: White or Colorless
• Material: Polystyrene
• Includes: Certificate of Calibration and Traceability to NIST
• Refractive Index: 1.59 at 589nm (25°C)
• Stability: Product stable for a minimum of 12 months

• Contents: Polystyrene microspheres in water
• For Use With (Application): USP Verification
• Product Type: Count Control Particles
• Particle Density: 1.05g/cm³
• Size Distribution: <3%