The primary method for sterilizing medical devices and combination products is gamma irradiation, which is also used for sterilizing pharmaceutical and biopharmaceutical drug products. However, there are concerns regarding the global supply of gamma irradiation due to its various downsides. These downsides include the need for a non-naturally occurring radioisotope (Cobalt-60), lengthy production time, limited global suppliers, logistical challenges, and safety implications. As the demand for terminal sterilization of drug products continues to rise, it is essential to consider alternative modalities such as E-Beam and X-Ray to ensure a reliable supply chain and support drug production. Read more >