Part II: Visible Inspection Data and the Sampling Inspection

This is Part II of a four part series that attempts to explain the background of the Knapp-Abramson analytical technique.  The series attempts to take the reader from viewing the inspection of product with a Probabilistic approach to a Deterministic approach using an advanced inspection device.

Excerpt from the article:

An initial use for this calibration curve can be the evaluation of the containers of an injectable product sampled to assure that the quality of the batch is acceptable under USP limits.  Each container in the sampled group is inspected optically with a low power stereo microscope.  Any particle detected in a container is sized and the particle size is evaluated with the calibration curve.  Only those containers with particles equal to or greater than the particle size at the edge of the Reject Zone are counted as sampling inspection rejects.

The seminal publication by Knapp in 1980 brought statistical replicability to the USP Assay for visible contaminating particles.  It was the first step away from the philosophical statement that injectable products must be absolutely free of visible contaminating particles to scientifically measurable data.

Follow the link below to download Part 2 of the Article.

Part II – Visible Inspection Data and the Sampling Inspection by Knapp and Budd