Towards microbiological quality assurance in radiation sterilization processing: a limiting case model

A Limiting Case Model has been developed which describes the dependence on radiation dose of the proportion of items, in a population of items subjected to irradiation, which are contaminated by one or more organisms. This model is independent of the initial distribution of numbers of micro-organisms on items and represents a conservative approach to estimation of the proportions of non-sterile items in an irradiated population of items.