MilliporeSigma

Sterile Filters

Sterile drug product

Sterile filtration is an important step in the drug production process and is routinely implemented for bacterial removal throughout bioprocessing to achieve bioburden control.  


For sterile filtration of aqueous liquids, we offer filters containing Durapore® polyvinylidene fluoride (PVDF) membranes and Millipore Express® filters containing polyethersulfone (PES) membranes. For sterile filtration of non-aqueous liquids, polytetrafluoroethylene (PTFE) membranes are available.

Selecting the right filter

Choosing the right sterilizing filter and device format for the process step or application is key to developing an efficient, cost-effective process. You can be confident our filter portfolio encompasses the standard-setting products your work deserves.
Filter selection is dependent on the feed characteristics and particulate levels, the level of contamination risk, and the specific process step. For critical aseptic processing operations, sterilizing-grade filters are the preferred solution. For non-critical or “low risk” operations such as buffer filtration and column protection, bioburden reduction filters may be used. 

  • All filters are fully scalable from small-scale tools to pilot and production-scale manufacturing
  • Most are offered as single-use capsules or cartridge filters
  • For plugging streams, high-area formats double the membrane area, without increasing filter footprint
  • Filters are offered in autoclavable, gamma-compatible or pre-sterilized formats with different connection options

Regulatory Compliance

Complementing our product portfolio, the Emprove® Program consolidates comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format to simplify your compliance needs.



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Highlights

Find Your Filter – Which Aseptic Filter is Best for Your Process?
Find Your Filter – Which Aseptic Filter is Best for Your Process?

This webinar summarizes filter design, criteria for filter selection, and how new filter choices can maximize your productivity. 

Selection, sizing, and operation of bioprocess filtration trains for optimal performance
Selection, sizing, and operation of bioprocess filtration trains for optimal performance

A model and test methodology are described for rapidly and efficiently determining an optimal prefilter and final filter system design for filtration of bioprocess fluids.

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