Determining whether a product is steam sterilizable.
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).
Moldenhauer
J E
JE
Fujisawa USA, Incorporated, Deerfield, Illinois, USA.
D006358:Hot Temperature; D013242:Sterilization