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QbD for Elastomer Development in the Aerosol Supply Industry

Williams G, Leone P, Grosjean B, Sarrailh S, Robins E, Brouet G.

Respiratory Drug Delivery 2008. Volume 1, 2008: 249-258.

Abstract:

This paper describes the application of Quality by Design (QbD) in the development of elastomer components for use in metered dose inhalers. The general path in a quality by design approach described here involves defining the desired product performance, identifying those product characteristics that are critical quality attributes (CQAs) then creating or using an established knowledge space in order to then establish one or more design space(s) and an appropriate control strategy to reliably deliver a product that meets requirements. All this gathered information and knowledge may then be leveraged through a well-managed quality and regulatory system to facilitate continual improvement throughout the product lifecycle