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Plastics & Elastomers
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All Plastics Are Not Created Equal

SpecialChem / Nov 5, 2007

Medical device manufacturers invest a great deal of time and money ensuring that their products meet both product performance needs and FDA guidelines. Choosing the appropriate plastic is critical for successfully bringing a combination product, such as a drug eluting stent or drug inhaler, to market. To decrease the time required for testing prior to device commercialization, manufacturers perform accelerated aging studies to determine physical aging. It is this essential test that is critical for documenting expiration dates for combination medical products. Considering key variables at the beginning of product specification is essential to guaranteeing medical device integrity. Material aging information, including physical, thermal, and optical performance over time, is imperative for ensuring product integrity to meet stringent FDA validation requirements, including evidence of sterility and fitness-for-use over a product's life cycle. As an example, in a case where a product needs a five-year shelf life to allow time for distribution, storage, and other constraints, the quality of the package/device combination should be monitored.

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