Validating and maintaining sterility in RTU packaging
Guaranteeing sterility is key to understanding the design of sterilization processes and its impact. It is important to realize that sterility is about probabilities rather than absolute values. Meaning how great is the probability that a sterilized object will have surviving organisms on it, and what are the consequences to the “product” as a result of this guarantee, e.g. dangerous levels of sterilant residuals and/or detrimental effects on the packaging materials.