This is Part IV 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:
The minimum average batch rejection probability cannot be evaluated with the present individual component piece-wise testing procedure now in use. This approach to the determination of system capability in automotive engine terms is the equivalent of testing the dimensions of individual components of an engine and using those tests to evaluate the dynamic performance of the engine. The failure to implement performance testing before production begins means that dynamic testing is performed with the loss of pharmaceutical product. The minimum average batch rejection probability can be evaluated by testing a fully processed and assembled container group; such as the quantity of containers used for the media fill test. This can be performed with a test group of containers filled with WFI, stoppered and capped in the normal procedure.
Follow the link below to download Part 4 of the Article.
Part IV – New Developments in Visual Inspection by Knapp and Budd
This is the concluding article of the series. additional information about the described instrumentation is available upon request.