By Paul Priebe
Gamma irradiation is a key technology for the sterilization and bioburden control of medical devices and single-use bioprocess systems. Gamma irradiation is a convenient means of sterilization since products to be sterilized may be bulk packaged, even including palletization in some facilities, without special vapor permeable packaging required for ethylene oxide gas. Sterilization validation and parametric release is a relatively straightforward exercise outlined in ISO 11137, which can be conveniently applied to industrial processes allowing parametric release of lots based on bioburden assessments & dosimetry, without the need for sterility tests.
This blog offers valuable insights into gamma, Ebeam and X-ray sterilization modalities as well as regulatory considerations. Learn about comparatives studies by leading academic and trade organizations and the conclusions they draw on sterilization techniques.