Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards

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

Applications
· Validating liquid particle counters to meet global pharmaceutical regulations
· Checking for particulate matter in injections