Chapter 9 - Regulatory pathway for labeling combination products as sterile

Abstract

One of the most challenging hurdles for combination products or products sensitive to standard sterilization processes is understanding the requirements for making a claim in the labeling of the product that it is sterile and the regulatory pathway to making such a claim. The broad assumption in the industry is that if a combination or sensitive product cannot be sterilized to a maximal sterility assurance level (SAL) of 10−6 using traditional sterilization processes, it automatically must be manufactured using aseptic processing. Several standards, such as ISO 13408-1 and European Agency for the Evaluation of Medicinal Products (EMA) guidance of the sterilization of medicinal products, state that terminal sterilization is preferred for providing sterile product, with aseptic processing being an option if terminal sterilization is not possible. To that end, new guidelines are available that facilitate the understanding of and provide guidance in situations when terminal sterilization at an SAL other than 10−6 might be acceptable.