Sterile Liquid Filters
0.2 µm filters for producing sterile filtrate in aseptic processing
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Description
Sterilizing-grade liquid filters, commonly referred to as sterile liquid filters, are expected to produce sterile effluent under process conditions.
The FDA’s Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice” (September 2004) states: “A sterilizing filter should be validated to reproducibly remove viable microorganisms from the process stream, producing a sterile effluent”. The guideline also states that “The microorganism Brevundimonas diminuta (ATCC 19146), when properly grown, harvested and used, is a common challenge organism for 0.2 micron rated filters because of its small size (0.3 micron mean diameter)”.
In addition, the Food and Drug Administration (FDA) guidelines on Sterile Products Produced by Aseptic Processing (1987) state: “A sterilizing filter is one which, when challenged with the micro-organism Brevundimonas diminuta (B.diminuta), at a minimum concentration of 107 organisms per cm2 of filter surface, will produce a sterile effluent.”
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-molecule drug products
- final filtration of large-molecule drug products
Our polyethersulfone (PES) membrane filters exhibit high flow rates and high capacity for fouling feeds.
These are utilized in a diverse number of filter-intensive bioprocessing applications including:
- growth media
- buffers
- intermediates
- final filtration of large-molecule drug products
Specifications
Pall® Sterile Liquid Filter Comparisons
Family/Grade |
Supor® EX |
Supor |
Fluorodyne® II |
Fluorodyne EX |
|---|---|---|---|---|
| Media
|
ECV | EKV | DFL | EDF |
Membrane material |
Polyethersulfone (PES) |
Polyethersulfone (PES) |
Polyvinyldifluoride (PVDF) |
Polyethersulfone (PES)/Polyvinyldifluoride (PVDF) |
Layers |
Double | Hybrid | ||
Support and drainage layer/core/cage/endcap material |
Polypropylene | |||
For Hard-To Filter Fluids: Supor EX Grade ECV Filters
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 filters are an excellent choice for hard-to-filter fluids.
They are also ideal for vaccine compounds and high-viscosity formulations such as traditional recombinants and high-particulate formulations.
For Low-Viscosity Formulations: Supor EKV Filters
Supor EKV filters have optimum flow, throughput, are very low protein binding, and have high chemical (pH) compatibility characteristics for maximum transmission of high-value active ingredients and preparative applications.
They are also available in our most comprehensive range of formats making them suitable for a wide variety of applications.
For Low-Fouling Drug Products: Fluorodyne II DFL Filters
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.
For High-Fouling Preparative Fluids and Final Drug Product Fluorodyne EX EDF Filters
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 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.
Applications
Application |
Process Stage |
Fluid Type |
Supor® EX Grade ECV Filters |
Supor® EKV Filters |
Fluorodyne® II DFL Filters |
Fluorodyne® EX EDF Filters |
|---|---|---|---|---|---|---|
Classic Pharma, Large-Volume Parenterals |
Formulation and Filling |
Large-Volume Parenterals |
Alternative |
Alternative |
Recommended |
|
Classic Pharma, Large-Volume Parenterals |
Upstream Processing |
Growth Media |
Recommended |
Alternative |
|
|
Classic Pharma, Large-Volume Parenterals |
Upstream Processing |
Bioreactor Additions |
Recommended |
Alternative |
|
|
Classic Pharma, Large-Volume Parenterals |
Upstream Processing |
Buffers |
Recommended |
Alternative |
|
|
Classic Pharma, Large-Volume Parenterals |
Downstream Processing |
Intermediate |
|
|
Recommended |
|
Classic Pharma, Large-Volume Parenterals |
Formulation and Filling |
Classic Small-Molecule |
|
|
Recommended |
|
Classic Pharma, Large-Volume Parenterals |
Formulation and Filling |
Complex Small-Molecule |
Recommended |
Alternative |
|
|
Plasma Therapeutics |
Downstream Processing |
Buffers |
Recommended |
Alternative |
|
|
Plasma Therapeutics |
Downstream Processing |
Intermediate |
Recommended |
Alternative |
|
|
Plasma Therapeutics |
Downstream Processing |
Final Bulk Drug Substance |
Recommended |
Alternative |
|
|
Plasma Therapeutics |
Formulation and Filling |
Classic Low-Concentration |
|
|
Recommended |
|
Plasma Therapeutics |
Formulation and Filling |
Classic High-Concentration |
Recommended |
Alternative |
|
|
Vaccines |
Upstream |
Growth Media |
Recommended |
Alternative |
|
|
Vaccines |
Upstream |
Bioreactor Additions |
Recommended |
Alternative |
|
|
Vaccines |
Downstream |
Buffers |
Recommended |
Alternative |
|
|
Vaccines |
|
|
Recommended |
Alternative |
|
Alternative |
Vaccines |
Downstream |
Intermediate |
Recommended |
Alternative |
|
|
Vaccines |
Downstream |
Final Bulk Drug Substance |
Recommended |
Alternative |
|
|
Vaccines |
Formulation and Filling |
Subunit or Toxoid |
|
|
Recommended |
|
Vaccines |
Formulation and Filling |
Live Attenuated, Inactivated or Adjuvanted |
|
Alternative |
|
Recommended |
Biotech Drugs |
Upstream |
Growth Media |
Recommended |
Alternative |
|
|
Biotech Drugs |
Upstream |
Bioreactor Additions |
Recommended |
Alternative |
|
|
Biotech Drugs |
Downstream |
Buffers |
Recommended |
Alternative |
|
|
Biotech Drugs |
Downstream |
Post-Harvest |
Recommended |
Alternative |
|
Alternative |
Biotech Drugs |
Downstream |
Intermediate |
Recommended |
Alternative |
|
|
Biotech Drugs |
Downstream |
Final Bulk Drug Substance |
Recommended |
Alternative |
|
|
Biotech Drugs |
Formulation and Filling |
Biotech Drug – Low Concentration Formulation (greater than 50 mg/ml) |
|
|
Recommended |
|
Biotech Drugs |
Formulation and Filling |
Biotech Drug – Low Concentration Formulation (greater than 100 mg/ml) |
Recommended |
Alternative |
|
|
Viral Vectors |
Upstream |
Growth Media |
Alternative |
Recommended |
|
|
Viral Vectors |
Upstream |
Bioreactor Additions |
Alternative |
Recommended |
|
|
Viral Vectors |
Downstream |
Buffers |
Alternative |
Recommended |
|
|
Viral Vectors |
Downstream |
Post-Harvest |
Alternative |
Recommended |
|
|
Viral Vectors |
Downstream |
Intermediate |
Alternative |
Recommended |
|
|
Viral Vectors |
Downstream |
Drug Substance |
Alternative |
Recommended |
|
|
Viral Vectors |
Formulation and Filling |
AAV/AV/Oncolytic |
|
|
Recommended |
|
Viral Vectors |
Formulation and Filling |
Lentivirus |
Alternative |
Recommended |
|
Alternative |
Nucleic Acids |
Upstream |
Growth Media |
Alternative |
Recommended |
|
|
Nucleic Acids |
Upstream |
Bioreactor Additions |
Alternative |
Recommended |
|
|
Nucleic Acids |
Downstream |
Buffers |
Alternative |
Recommended |
|
|
Nucleic Acids |
Downstream |
Post-Harvest Post Synthesis |
Alternative |
Recommended |
|
|
Nucleic Acids |
Downstream |
Intermediate |
Alternative |
Recommended |
|
|
Nucleic Acids |
Downstream |
Drug Substance |
Alternative |
Recommended |
|
|
Nucleic Acids |
Formulation and Filling |
Liposome Nanoparticle Vectors |
Alternative |
Recommended |
|
Alternative |
Need more help choosing the right filter?
Our Scientific and Laboratory Services (SLS) team 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.
Documents
Application Notes
-
Innovative Membrane Filtration Technologies for Upstream and Downstream Bioprocessing
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Considerations on Re-Use of Sterilizing-Grade Filters
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Re-Use of Sterilizing Grade Filters – Considerations and Risk Assessments
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Successful Sterile Filtration of a Squalane Emulsion
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Technical Guide
-
Revalidation of My Sterile Filtration Step: When and Why Is It Needed?
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White Paper
-
A Risk Based Approach to Validation Studies for Sterilizing Filtration and Single-Use Systems
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