This Paper was presented by Julius Z. Knapp and Gerald W. Budd at the 2005 PDA Annual conference in Chicago, IL. The purpose of the paper was to detail the existing statistical technique for the determination of product quality used in the pharmaceutical industry for Parenteral products and to introduce a new instrumentation that could accurately measure, non-destructively, the size of a contaminating particle in a container. The paper provides an excellent background for the Knapp-Abramson statistical approach and how this new Deterministic approach might be applied.
The paper is provided in PDF format and has be divided into four section for easy download.
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