CASCADE IMPACTION (CI)
The IPAC-RS Casecade Impaction (CI) Working Group's overarching goal is to determine and publicize best scientific approaches for aerodynamic particle size distribution (APSD) measurements (such as by CI) in the context of characterization, change and control of OINDP.
Currently, the CIWG is completing an experiment to further study the ability of efficient data analysis (EDA) to detect changes in APSD of a metered dose inhaler (MDI). The experiment is being conducted in parallel in three different laboratories.
A subgroup of the CI WG is also developing best practices for abbreviated impactor measurement (AIM) testing of dry powder inhalers (DPIs).
Publications and Presentations
April 18, 2020
Click below to access all Cascade Impaction Tutorials
PRODUCT QUALITY DEMONSTRATION
STRATEGY (PQDS)
The overall objectives of the PQDS Working Group are to explore improved methods for PQDS control; equip companies for successful discussion of appropriate PQDS controls with regulators; monitor, report on, analyze and react to ongoing developments affecting PQDS controls in OINDPs, including those in regulatory guidances, pharmacopeial chapters, ISO standards, conference presentations and published articles; and, as necessary, prepare comments on proposed standards and regulations affecting PQDS controls for OINDP.
The current focus of the PQDS WG is developing a framework for adopting aggregate approaches to lot testing (already standardized in other industries) to the context of pharmaceutical quality control, in particular PQDS testing of OINDPs, is our current focus.
Publications and Presentations
15 November 2001
A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products (15 November 2001)
Includes work by the IPAC-RS PQDS Working Group (WG) and its predecessors (Delivered Dose Uniformity (DDU) WG, and Dose Content Uniformity (DCU) WG)
PLUME CHARACTERIZATION
The Plume Characterization Working Group shares experiences, knowledge and information related to plume characterization testing, methods, and regulation, with the goals of advancing the application of and regulation regarding this type of testing for OINDP. The WG holds discussion sessions, exchanges and discusses case studies and data, conducts industry surveys, and has presented extensively on its work in public forums. The WG is developing a publication on the current state of the art of plume characterization testing (plume geometry and spray pattern testing) and current international regulatory expectations regarding such testing.