Sterile Filtration and Bioburden Control
Bioburden control in pharma and biopharma processes is critical to assuring the microbial safety of drugs for patients. Bioburden reduction and sterilizing filters are integral components of all bioburden control strategies. Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream; from cell culture media through process intermediates to final sterile filtration. Our membrane filters offer the highest level of sterility assurance, are available in different formats, and are supported by comprehensive documentation packages to meet your compliance needs.
For non-destructive filter integrity testing that is fast, reliable, and repeatable, the Integritest® 5 automated test instrument allows bubble point and diffusion testing inline or offline, with additional capability for hydrophobic filter testing when paired with the Exact-Air™ II water-based test unit.
Pre-configured to meet all your biopharmaceutical process and filtration needs, our Series 4000™ line of single-round stainless steel filter housings offers a variety of T-Line and In-Line designs, as well as a wide range of tube sizes.
Sterile filtration with disposable filters is a common operation in bioprocessing and part of every bioburden control strategy. Sterile filtration assures microbial safety of the drug for patients. Learn how to select the best sterilizing filter for your process step.
Prefilters are used to remove particulates and protect downstream unit operations. They can be used to provide column protection or in front of a sterilizing-grade filter to improve capacity. Learn how our cost-effective prefilters can enhance your process economics.
Gas vents and vent filters used throughout biomanufacturing help maintain near-ambient pressure in product tanks, bioreactors, closed systems, and/or related utilities. Find the right sterile vent filter for your process application needs.
Pre-sterilized, single-use filling systems offer speed and flexibility for critical final filtration and final fill operations. Learn how advances in aseptic filtration simplify PUPSIT and enable optimized sterile fill finish operations.
There are multiple options for buffer filtration in biomanufacturing. Filter selection is based on process biosafety needs, buffer throughput and economics. Filters for processing buffers in biomanufacturing provide bioburden control, sterilizing-grade or virus retention performance.
Cell culture media filtration prevents bioreactor contamination. Selection of a sterilizing filter, mycoplasma filter, or virus filter depends on process risk. Learn how to select the best filter for your cell culture media filtration.
Mobius® 2D and 3D single-use assemblies and systems for sterile fluid management offer flexible manufacturing options for biopharmaceutical companies, from media and buffer preparation to final fill applications.
A closed sterile sampling method is increasingly preferred by regulatory authorities over traditional sampling methods, such as glass bottles or steam-in-place (SIP) stainless steel valves. The NovaSeptum® GO sterile sampling system is designed to provide you with the flexibility and safety you need when sampling at any point in your aseptic or sterile biomanufacturing process.
Our complete range of Mobius® single-use mixing solutions can meet your needs for mixing pharmaceutical ingredients from intermediate to final drug products, as well as preparation of process solutions such as buffers and media.
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