Key Elements of an Effective Testing Program to Identify Extractables and Leachables
May 30, 2013
By BioPharm International Editors
Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss the key elements of an effective testing program to identify extractables from materials and leachables in drug products.
Implementing process analytical technology for bioprocessing presents unique challenges, but the recent emphasis on establishing a thorough understanding of the manufacturing process is a key enabler of PAT approaches.