Medical products are more complicated and have greater challenges for sterilization
process than ever before.
These products might include tissue-based products,
combination products, devices with drug coatings, devices with batteries or
equipped with...
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Medical products are more complicated and have greater challenges for sterilization
process than ever before.
These products might include tissue-based products,
combination products, devices with drug coatings, devices with batteries or
equipped with integrated software, circuits or computer chips.
Each of these present their own challenges for sterilization starting with
selecting a compatible process to developing the validation strategy and meeting
the regulatory requirements for ensuring that the sterilization process is adequate
for the medical product.
Making a mistake can be costly not only in immediate costs
but also in project delays and potentially in regulatory approval.
This presentation will review various sterilization processes and their general
compatibility to various types of challenging medical products as well as some of
the challenges that each of the various sterilization processes might present.
In
addition the methods that are available for validation will
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