Gamma Irradiation - Using A Risk-Based Approach To Sterility Requirements For Single-Use Systems

Gamma irradiation has been around for over 20 years and is the most used method of sterilization and bioburden control for single-use bioprocess systems. However, there is still some confusion around the need for sterile or bioburden-controlled systems and how to accomplish it.

Read our latest blog which explains the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fit into biopharmaceutical manufacturing processes.