Regulatory pressure to adopt terminal-sterilization processes has promoted radiation sterilization. Radiation sterilization may be performed using either gamma rays from a radioisotope source (usually ...

Manufacturers must keep in mind the limitations that e-beam sterilization imposes. For one, the technique requires a small target and is ineffective against large targets such as pallets. And because ...

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

If you would like to learn more about the IAEA’s work, sign up for our weekly updates containing our most important news, multimedia and more.

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

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.

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 ...