ABSTRACT

No quality control test, parenteral or nonparenteral, presents more difficulties for quality control specialists than inspection and analysis of injectable solutions for the presence of foreign particulate matter. The oldest, yet most commonly used, test for particulate matter evaluation involves human visual examination. Such examination is subjective, time consuming, and limited in the types of parenteral products and containers that can be inspected. This has stimulated many studies regarding ways of not only improving efficiency of human inspection, but also developing and improving methods of detecting particulate matter electronically.