Product life cycle approach to cascade impaction measurements

Abstract

Over the OIP life cycle (from development to commercial production, to the development of generic/follow-on products), APSD measurements are used extensively but for different purposes. The analytical and statistical approaches to the measurements and data analyses at these stages must therefore be different, depending on the specific questions pursued in a given situation. For some of those questions, full-resolution CIs are the instrument of choice. For others, an AIM system can provide all the needed information and support decision-making. This chapter describes how the utilization of specific measurement approaches changes over the product life cycle, and how the entire body of APSD data is interlinked to enable those transitions (e.g., by establishing correlations or by establishing typical profile parameters), thereby enhancing product knowledge, appropriate control, and comparisons between innovator and generic OIPs.