Integrated Approach for Bulk Pharmaceutical Sterilization
Bryce Telford2, Zabrina Tumaitis1.
1Expert Advisory Services, Sterigenics, Oak Brook, IL, United States; 2Expert Advisory Services, Nelson Laboratories, Salt Lake City, UT, United States
Development of a holistic path to validation of bulk sterilized pharmaceuticals, from determination of the maximum dose through sterilization dose establishment and process qualification. This presentation provides guidance to optomize doses, testing strategies, and necessary considerations for a successful routine sterilization program.
