Pharm-Trol Count Precision Size Standards

PHARM-TROL™ Particle Count Control is a product containing National Institute of Standards and Technology (NIST) traceable size standards with a measured particle count. The product was developed to provide process control data for particle counting consistency and verification of size calibration. The ready-to-use precision standard is 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 microsphere suspension with a known concentration. The data provides documentation for internal or customer quality audits.The product is ideal for parenteral drug manufacturers seeking interim verification of USP <788> and <789> “Particulate Matter in Injections”, Light Obscuration Particle Count Test. PHARM-TROL™ is prepared with the same exacting procedures as the USP Count Reference Standard.

These ready-to-use precision standards are designed for regular use in liquid particle counters. The product is a 15µm polystyrene microsphere suspension packaged at 3800 particles per milliliter (mL) in 25mL single-use quantities. It is supplied in convenient 6 or 20 bottle sets. Each package contains a Certificate of Calibration and Traceability to NIST.

part no nominal diameter quantity bottle size
CS-PK 15µm 6 bottles 25ml
CS-BX 15µm 20 bottles 25ml

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. Compliance: NIST traceable.

Recommended for: Particle count control for USP <788> and <789> verification in liquid particle counting.

application:
particle-counting
MSDS
 

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