Sterile Liquid Filters

0.2 µm filters for producing sterile filtrate in aseptic processing

 

Shop Sterile Liquid Filters

 

Supor® EX Grade ECV Filters

Supor® EKV Filters

Fluorodyne® II DFL Filters

Fluorodyne® EX EDF Filters

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Validated, 0.2 µm sterilizing-grade filters with a unique combination of Ultipleat® filter construction and built-in prefiltration to give longer filter life and lower filtration costs. Suitable for sterile filtration of a wide range of fluids including buffers, biological fluids, tissue culture media, ophthalmic products and many others

Validated, 0.2 µm sterilizing-grade filters with a unique combination of Ultipleat® filter construction and built-in prefiltration to give longer filter life and lower filtration costs. Suitable for sterile filtration of a wide range of fluids including buffers, biological fluids, tissue culture media, ophthalmic products and many others

Validated, 0.2 µm sterilizing-grade filters with a unique combination of Ultipleat® filter construction and built-in prefiltration to give longer filter life and lower filtration costs. Suitable for sterile filtration of a wide range of fluids including buffers, biological fluids, tissue culture media, ophthalmic products and many others

Posidyne® Filter Cartridges are the ideal components for fine particle retention. All Pall filters are 100% integrity tested and manufactured under GMP compliance. The construction is resin free with wettable capabilities. Posidyne has Zeta potential to provide enhanced particle retention and endotoxin removal. Filters are available in bioreduction and sterilizing grades as well to best fit several biotech systems.

Kleenpak™ Capsules with Posidyne® Membrane meet cleanliness requirement per USP Particulates in Injectable. It features positive Zeta potential for enhanced efficiency in aqueous solutions. Capsules contain a double-layer sterilizing membrane for high reliability and high-quality product. Filters are self-contained and designed for small sterile filtration systems throughout a range of acidic to basic solutions.

Specifically engineered for fine filtration, prefiltration and bioburden reduction of a wide range of pharmaceutical and biological liquids, providing reliable, economical and efficient particulate and bioburden removal

Self-contained sanitary filters designed for convenient small-batch sterile filtration of most biopharmaceutical solutions, with a rugged, compact design to ensure reliability

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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.

 

Learn more

 

 

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.

 

Learn more

 

 

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.

 

Learn more

 

 

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.

 

Learn more

Applications

 

Application

Process Stage

Fluid Type

Supor® EX Grade ECV Filters
(PES Membrane)

Supor® EKV Filters
(PES Membrane)

Fluorodyne® II DFL Filters
(PVDF Membrane)

Fluorodyne® EX EDF Filters
(PES/PVDF Membrane [Hybrid])

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


Downstream


Post-Harvest

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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