Selection & Validation of Casacde Impactor Test Methods

Conducted April 27th, 2004 at Respiratory Drug Delivery IX, Palm Desert, CA

About this Panel Discussion: This panel discussion provides a broad perspective on the 'Selection and Validation of Cascade Impactor Test Methods', and stimulates debate on some of the major problems which require general resolution by the pharmaceutical industry.

Discussion Format:

• The panel discussion is presented as a series of audio lectures and synchronized powerpoint slides which were recorded at Respiratory Drug Delivery IX.
• A panel of experts from the pharmaceutical industry and Food and Drug Administration (FDA) debated the merits of all cascade impactors that are listed in the United States Pharmacopeia (USP 25) together with the recently introduced Next Generation Impactor (NGI).
• RDD Online® prepared slides to help summarize the issues discussed during the Q&A session.
• The advocacy article published in the RDD IX Proceedings is also available.
• View the free introduction.
• Register to access the complete series of presentations for 1 year as described below.

Selection and Validation of Cascade Impactor Test Methods Peter R Byron, Virginia Commonwealth University FREE. This presentation introduces the debate, and stimulates discussion about some of the major problems associated with the selection and validation of cascade impactor test methods.

Selection and Validation of Cascade Impactor Test Methods: Data Variability Guirag Poochikian, Food and Drug Administration REGISTERED USERS ONLY. This presentation provides the FDA's perspective on particle size distribution (PSD) methods and data variability. Factors which impact apparent PSD variability are addressed and illustrative examples provided alongside the discussion of data handling issues.

Perspectives on Validation of Cascade Impaction Methods Harris Cummings, Cardinal Health REGISTERED USERS ONLY. This presentation discusses the calibration of cascade impactors, specifically what 'calibration' means during routine impactor use. System suitability tests are discussed with ways of handling mensuration data for typical impactors.

Precision Limitations of the Andersen Mark II Cascade Impactor Stephen W Stein, 3M Drug Delivery Systems REGISTERED USERS ONLY. This presentation reviews some of the factors controlling the limits of precision in the Andersen cascade impactor.

Andersen Cascade Impactor Specifications & Manufacture - Past and Present Michael J Smurthwaite, Westech Instrument Services REGISTERED USERS ONLY. This presentation reviews the history of the Andersen cascade impactor in the pharmaceutical industry, and explains some of the variability, changes and improvements seen with the ACI over the years.

Next Generation Impactor-what makes it a good impactor? Keith G Truman, GlaxoSmithKline REGISTERED USERS ONLY. The use of the Next Generation Pharmaceutical Impactor is advocated in this presentation. Factors and test method variables which influence final data variability from cascade impactors are also highlighted.

The European Pharmaceutical Aerosol Group NGI Collaborative Study Steven C Nichols, Aventis REGISTERED USERS ONLY. This presentation illustrates some of the results of the EPAG collaborative study which compared the NGI with the ACI, and also the MSLI.

RDD IX Panel Discussion Peter R Byron, Virginia Commonwealth University REGISTERED USERS ONLY. This presentation includes slides from RDD Online to help summarize the Panel Discussion at Respiratory Drug Delivery IX. By participating in the panel discussion, John Simons (3M Drug Delivery Systems), Craig Dunbar (Alkermes), Nick Miller (for MSP Corporation), Jolyon Mitchell (Trudell Medical International), Nani Kadrichu (Nektar Therapeutics), Shyamala Ivatury (PPD Development) and Chris Shelton (Cardinal Health) agreed to permit the inclusion of their questions and comments in this presentation.