ABSTRACT

Filtration applications are expanding and with the expansion, new filter designs and filtration purposes are evolving. Buffer filtration with low fouling or blocking potentials is commonly high-flow applications. The processing of buffer batches needs to be fast and efficient, the design of the filtration system is very different than the one used in media filtration. A Parenteral Drug Association task force worked on multifaceted solution of these issues, which include novel detection methodologies, inactivation steps, and removal by filtration, including a microbial challenge standard for 0.1 micron filtration steps. The lower the differential pressures at start of the filtration, the better the performance. Mycoplasma removal by filtration with 0.1 micron-rated filters is one possible step within a process. In instances, buffers are also used to pre-wet or flush either filtration systems or any equipment to avoid potential product alterations, degradation, or precipitation. Filtration of buffers happens most commonly from a mixing vessel into a hold vessel.