Maximize yield and efficiency in critical aseptic applications
Optimized sterilizing-grade liquid filtration in your drug manufacturing process drives efficiencies while providing confidence in achieving drug critical quality attributes.
Selecting the right sterile filter media and format, for your specific process helps to maximize yield and recovery of valuable drug product and ensure production efficiency.
Our extensive range of sterilizing-grade liquid filters and formats enable us to offer filtration solutions for all applications and drug types, from mAbs, recombinant proteins, vaccines and gene therapies to small-molecule drugs and plasma derivatives.
All of our sterilizing-grade liquid filters have been validated to provide a sterile filtrate when subjected to a liquid bacterial challenge, using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 10⁷ cfu/cm² and therefore conform with the applicable requirements of the “FDA Guideline Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (September 2004).”
New challenges and advancements in sterilizing-grade liquid filtration
Developments in gene therapies, high concentration mAbs for subcutaneous administration and novel nanoparticle drug delivery systems, such as liposomes and emulsions, present new challenges for sterile filtration and validation. Small batch volumes require maximum product recovery driving the need for filtration solutions with enhanced performance capabilities
Our newest filters feature design adaptations to improve throughput, reduce footprint and minimize hold up volume:
- Smaller, more cost-effective filtration systems due to maximized membrane area with laid over, pleat membrane
- High flow rates and reduced filtration time due to asymmetric membrane technology and narrow core design
Selecting the right filter for your application
Our polyvinylidene fluoride (PVDF) membrane filters have low extractables and exhibit low adsorption of active ingredients. For this reason they are typically used in final filtration of small and large molecule drug products.
Our polyethersulfone (PES) membrane filters exhibit high flow rates and high capacity for fouling feeds. They are utilized in a diverse number of filter-intensive bioprocessing applications; growth media, buffers, intermediates and final filtration of large molecule drug products.
Sterilizing-grade filter selection guide
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Supor EX ECV for exceptional flow rates and hard-to filter fluids
Supor EX ECV filters offer superior flow rates and capacity due to a unique membrane pairing, laid over pleat geometry and narrow core design. With excellent pH compatibility and protein transmission of active ingredients, Supor ECV is an excellent choice for hard to filter fluids. Super EX ECV is ideal for vaccine compounds and high-viscosity formulations such as traditional recombinants and high-particulate formulations.
Fluorodyne II DFL for low-fouling drug products
Fluorodyne II DFL filters are our most widely used filter in low fouling final drug product filtration. They are most suitable for these critical applications due to their low extractables, low adsorption and proven performance during process specific validation studies.
Fluorodyne EX EDF for high-fouling preparative fluids and final drug product
Fluorodyne EX EDF filters feature a unique hybrid filtration media that enables outstanding capacity with fluids that tend to foul traditional sterilizing-grade filters. Including some of our most advanced design innovations such as laid over pleat construction and an asymmetric PES membranes, these filters perform especially well downstream of cell harvest and also when used for the filtration of formulations incorporating liposomes and emulsions.
Need help choosing the right filter?
Our Scientific and Laboratory Services (SLS) have been helping our customers optimize their processes for more than 50 years. Together with our wide range of filter membranes, we can find the right filtration solution for your fluid or help to optimize your sterile filtration process. Request a consultation with one of our sterile filtration specialists to discuss your process and offer free support to help you get it right.