Pharmaceuticals 2011 - Understanding ISO 14644-1: What is Required of Pharmaceutical Manufacturers

This ISO 14644-1 training will cover the exact procedure for carrying out particle count testing in pharmaceutical clean rooms. It will focus on statistical analysis of results and reporting and data interpretation.

ISO 14644-1 is a standard that is accepted by most regulatory agencies for Pharmaceutical clean rooms.

ISO 14644-1 is the most comprehensive particle count procedure since it covers the statistical base for computing the clean room classes, the apparatus specifications, the sampling locations number determination, the sampling volume, the data interpretation, statistical analysis of the results and the graphical illustration of the acceptance criteria.