PT  - JOURNAL ARTICLE
AU  - Jeanne E. Moldenhauer
TI  - Determining Whether a Product Is Steam Sterilizable
DP  - 1998 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 28--32
VI  - 52
IP  - 1
4099  - http://journal.pda.org/content/52/1/28.short
4100  - http://journal.pda.org/content/52/1/28.full
SO  - PDA J Pharm Sci Technol1998 Jan 01; 52
AB  - 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).