Science & Research

Toward Enhanced Machine-Based Release in X-ray Sterilization

This article, published in BI&T/AAMI Array, presents a novel method and detector system for use in radiation processing using X-ray.  The system would allow real-time monitoring of each pallet being processed and ensure that the correct X-ray beam is directed to the product.  The process...

Bovine pericardium or porcine tissue are increasingly used to make heart valves. These biological prostheses now tend to be preferred but they pose a problem of durability. Our member Fraunhofer FEP in Germany has developed a multi-component process called SULEEI for longer functional life of biological...

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Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the...

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