Ruggedness and Robustness in Nitrosamine Analysis from Pharmaceutical Elastomers

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Presented by

Jason Creasey, at Maven E&L Ltd and Ank Reumer, at Nelson Labs

About this talk

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Ank Reumer, Senior Study Director, Quantitative Methods Team at Nelson Labs This webinar will outline elements to consider in the ruggedness and robustness of methods of analysis for nitrosamine from elastomers used in pharma. It will present a review of sources of nitrosamines in elastomers, together with how these have changed over time. It will give a chronology of the concerns and regulatory interest in nitrosamines over the last forty years. It will review choices that need to be made for methods of analysis during development of a method, and it will explore how those choices might influence the quality of the method produced. The webinar will present key factors to consider when creating a robust and reliable method and how analysis of pharmaceutical elastomers must consider the sample preparation considerations which may be specific to this application. The webinar will also illustrate the validation of a method for nitrosamines and show each element of the validation to consider together will hints and tips to ensure any method is both robust and rugged when challenged and operated in routine use. Followed by Packaging related nitrosamines in Drug Products For many years it has been known that Pharmaceutical Elastomers are the potential source of the existence of nitrosamines in Drug Products. With the recent regulatory spotlight on nitrosamines, other Pharmaceutical packaging constituents came into the picture. In this presentation, case studies will be presented where Extractables screening of primary and secondary packaging materials could assist in the risk evaluation /assessment for the presence of nitrosamines in the related Drug Products. In addition, case studies of Leachables screening in Drug Products will be presented to demonstrate their assistance in the risk evaluation /assessment for the presence of nitrosamines in the concerned Drug Products.

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