title: Determining whether a product is steam sterilizable.
abstract: The FDA has issued proposed regulations to require that manufacturer's evaluate the "steam sterilizability" of parenteral products. There are many different ways to assess sterilizability. Within a company, it is helpful to standardize the methodology used to determine whether the product should be terminally sterilized. The following is one approach to determining product sterilizability. This approach is also depicted in a flow chart (Figure 4).
authors.affiliation: Fujisawa USA, Incorporated, Deerfield, Illinois, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Moldenhauer
mesh_terms: D006358:Hot Temperature; D013242:Sterilization