TY - JOUR T1 - Determining Whether a Product Is Steam Sterilizable JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 28 LP - 32 VL - 52 IS - 1 AU - Jeanne E. Moldenhauer Y1 - 1998/01/01 UR - http://journal.pda.org/content/52/1/28.abstract N2 - 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). ER -