Note: This article is based on the white paper "Establishing Bioburden Alert and Action Levels" available for download. Most national and international standards regarding bioburden, sterilization, or ...

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated ...

This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators. Gamma irradiation provides a number ...