Radiation Sterilization Master File Pilot Program FAQ

Q1: What is the Radiation Sterilization Master File Pilot Program? A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, changes to sterilization…

Activation Assessment (X-ray and electron beam)

Background Radioactive material of natural origin is abundant and varies widely in both type and amount. The energy from these materials, plus that of cosmic or cosmogenic origin, is called background radiation. Artificial radioactivity is the result of human operation where it was not previously present. Assessment of induced radioactivity in radiation-sterilized healthcare products is…

Radiation Verification Dose Transfer

Industrial radiation facilities are designed to achieve a dose uniformity inside a process load between the sterilization (minimum) dose and the maximal acceptable dose established during the validation process. To demonstrate continued effectiveness of the established sterilization dose, a dose audit is required to be performed at defined frequencies. This audit requires the treatment of…