Is there information available on irradiation and sterilization/validation?
BPSA has published a Guide to Irradiation and Sterilization of Single-Use Systems. This BPSA guide explains the basic principles of sterilization validation under ANSI/AAMI/ISO 11137, discusses considerations in choosing among alternate approach options, and suggests where microbial control by irradiation without validation may be applicable and beneficial in terms of development time and cost without compromising safety or quality.