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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 current assumptions to assure the patient's
best interests are met in the development of increasingly rigorous
sterilization methods used to counteract MRSA and other
'super-bugs'. In addition, the book discusses the special
challenges faced with implantable medical devices, sterilization
requirements and further methods needed for material selection and
the design process. This book is unique in taking a holistic,
end-to-end approach to sterilization, with a particular focus on
materials selection and product design.
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