Sterile Filtration and Prefiltration
Sterile filtration of a final purified product ensures safety. A final filter should provide sterile filtrate without altering the efficacy or potency of the product. This is best accomplished by using filters that are non-pyrogenic, with low binding and low extractables. Sterilizing filters must be integrity testable and either easily sterilized or supplied pre-sterilized. The final filter (or prefilter) combination must provide proper flow rate.
The complex interplay of filtration dynamics and the non-homogeneous nature of many process fluids can make filter selection difficult. In fact, there are often so many variables that the design and sizing of filtration systems remains—even today—more of a "practical art" than a precise science. Millipore has been synonymous with filtration for over 45 years. As the applications leader in pharmaceutical and biotechnology processing, we can help both with the science of filtration, and the art of putting together the right combination of filters for your process.
- What liquid are you filtering?
- What are some of the fluid properties; pH, viscosity, temperature, surface tenstion, stability, etc.?
- What are the important chemical components and their concentration?
- What pretreatment has been given to your fluid?
- What is your low rate and batch size?
Millipore has developed the science for filter sizing. If you need to run many trials to design and optimize your filtration train, Millipore’s Vmax Software simplifies your process. By extrapolating performance based upon data points such as time, volume, pressure, and other system information, the sizing software provides information that helps address filtration process scaling concerns for multiple interests. We also have a group of specialists to assist you in filter sizing based on a variety of filter configurations and process scenarios. Millipore filtration experts will prepare a comprehensive report of the test results, complete with recommendations for the optimal filtration train for your process
Durapore and Millipore Express membranes are long-time leaders in biopharmaceutical processing. Available in a variety of pore sizes and formats that offer you outstanding flow rates, throughput, low protein binding, low extractables and scalability.
