Parenteral drug manufacturers seeking an economical interim verification of particle counter performance to USP Monograph 788 can now achieve this using particle count control
Parenteral drug manufacturers seeking an economical interim verification of particle counter performance in accordance with USP Monograph 788, Particulate Matter in Injections, Light Obscuration Particle Count Test, can now achieve this using Duke Scientific's Pharm-Trol particle count control.
Manufactured using the same exacting procedures as those for the official USP Count reference standard, the Pharm-Trol Count Control consists of a uniform 15 micron polystyrene microsphere suspension containing 3800 particles per millilitre.
It is supplied in 25ml single use packing in convenient six- or 20-bottle kits, complete with certificate of calibration and traceability and MSDS.
The price of these kits is considerably lower than the corresponding USP Standard, enabling the regular collection of data on liquid particle counters to provide a continuous performance record ideal for internal documentation and customer quality audits at minimum cost.
