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.
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.
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.
Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
Tech Bulletin: Extended Bacterial Retention Testing of Millipore Express® 0.2 μm Filters in a Continuous Flow System
Webinar: Selection, Sizing, and Operation of Bioprocess Filtration Trains for Optimal Performance
Webinar: Find Your Filter – Which Aseptic Filter is Best for Your Process?
Webinar: Strategies to Address Bioburden Control in Downstream Processing
Webinar: Does Your SVP Process Assure Sterile Drug Product?
Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Webinar: Scale-up of High-Area Filters for Microfiltration of Biological Fluids
Tech Bulletin: Integrity Test Troubleshooting – Beyond Rewet and Retest
Tech Bulletin: Establishing Product Specific Bubble Point Specifications for Sterilizing Grade Filters
Webinar: Filter Integrity Testing Best Practices
Webinar: Potential Impact of Draft Annex 1 on Sterilizing Filtration
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.