Options for Extractables and Leachables Analysis in Filters

Overview:

Disposable equipment such as polymeric filters are finding increased use in aseptic processing. In order to be properly validated, these items need to be thoroughly tested for the presence of contamination. This article by Raymond Colton, Laura Okhio, Oscar W. Reif, Maik W. Jornitz and A. Mark Trotter of Sartorius BBI summarizes the various approaches that can be used to test these materials, as well as latest regulatory guidelines.