RT Journal Article
SR Electronic
T1 Determining Whether a Product Is Steam Sterilizable
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 28
OP 32
VO 52
IS 1
A1 Moldenhauer, Jeanne E.
YR 1998
UL http://journal.pda.org/content/52/1/28.abstract
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).