PHARM-TROL¢â Count Precision Size Standards
Thermo Scientific Pharm-Trol Count Precision Size Standards are for USP <788> and <789> verification. These ready-to-use precision standards are designed for regular use in liquid particle counters. This documents the reproducibility of the particle counter by permitting a continuous record of its performance using a NIST traceable microsphere suspension with a known concentration. The data provides documentation for internal or customer audits.
Pharm-Trol contains NIST traceable size standards with a measured particle count. The product was developed for manufactures 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). The particle diameters are traceable to the Standard Meter through the National Institute of Standards and Technology (NIST).
Pharm-Trol is prepared with the same exacting procedures as the USP Count Reference Standard and provides process control data for particle counting consistency and verification of size calibration.
Recommended for: Particle count control for USP <788> and <789> verification |