Determining Whether a Product Is Steam Sterilizable

The FDA has issued proposed regulations to require that manufacturer9s 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).