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Title: Operation Of The Light Extinction Particle Counter For Accurate Counting Results
Author: Julius Z. Knapp
Source: 1997 Measurement Science Conference
Year Published: 1997
Abstract: The United States Pharmacopeia has established mandatory limits for particle contamination that injectable products must meet prior to sale or use on human patients or animals. The utility and economic effectiveness of the light extinction particle counter for this determination is, by now, well established. The assay of particle contamination in small volume injectable containers to determine compliance with statutory limits encounters special problems. The Pharmacopeia specified a single contamination limit for all small volume injectable containers, those up to 100ml.This specification results in high particle concentration acceptance limits in the smaller containers. Count accuracy limits for these particle counters have until recently been based on the use of a flawed counter model and an inadequate measure of particle concentration. This combination of defects, particularly at particle contamination acceptance limits, can result in both false batch rejections and false batch acceptance.

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