View CartSelection & Validation of Cascade Impactor Test Methods
This panel discussion from Respiratory Drug Delivery IX 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.
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).
This presentation consists of a series of audio lectures and synchronized powerpoint slides. The duration of the full presentation is approximately 2 hours. It is possible to watch all, or only segments of, the presentation as time permits.
Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery IX Proceedings.
Selection and Validation of Cascade Impactor Test Methods
Peter R Byron
Virginia Commonwealth University
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
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
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
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
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
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
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
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.
