Radiation sterilization technology destroys the DNA and cellular structures of bacteria and microorganisms using electromagnetic waves with far higher energy than ultraviolet radiation.

Inside the evolving science of sterilization compatibility and why your next packaging decision might improve patient ...

The new guidance outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems. It is a Consensus Report, a document type based on ...

The agency said it may open a new master file program for radiation that follows an existing program that is agnostic as to sterilization method, and which may speed the adoption of alternative ...

but he adds that “many regulators are unfamiliar with X-ray sterilization.” Plus, he points out that some radiation regulatory standards, such as EU Annex 12, do not mention the use of X-rays.