Historical
PDA TR 30-2012
Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat
This PDA technical report is intended to provide a single-source set of recommendations on developing a parametric release program that include demonstrated best practices that should be considered for development of a moist heat sterilization program. The report is built on the foundation of moist heat sterilization science presented in PDA Technical Report No. 1, which may be referred to for greater detail on the science of sterilization, sterilization cycle development and validation (2).
Content Provider
Parenteral Drug Association [pda]
