GORE® Sterilizing-Grade Vent Filters

Designed to improve productivity by minimizing tubing kinking and other handling issues, GORE Sterilizing-Grade Vent Filters deliver the airflow of conventional 50 mm vent filters at a fraction of the size and weight.

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Sterilizing-Grade Vent Filters Data Sheet

Filtration Solutions for Life Sciences

GORE® Vent Filters are ideal for use in non-GMP, pre-GMP, or GMP-regulated environments working with monoclonal antibodies (mAbs), recombinant proteins, vaccines, conjugates, growth factors, and plasma-derived products.

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Overview

Smaller, Lighter-weight Vent Filters for Sterile Gas Filtration

Problems during processing can be costly. When vent filters are large and heavy — as they commonly are — tubes can kink, reducing airflow or blocking airflow entirely. This can lead to losses during processing and lapses in productivity, while the large size of the vent filters can clutter a work area.

GORE Sterilizing-Grade Vent Filters are the smallest, lightest-weight vent filters available for use in small-scale sterile gas filtration today. At a fraction of the size and weight of the larger, heavier 50 mm vent filters commonly used in bioprocessing, our vent filters virtually eliminate handling issues like tubing kinking and limitations due to space constraints.

Manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP), our vent filters help ensure peak performance, and potential time and money savings, by doing more with less.

Flask comparing tubes with 50 mm vent versus GORE Vent Filter

Commonly used 50 mm vent filters are heavy, weighing down tubing and blocking airflow.  Smaller, lighter-weight GORE Sterilizing-Grade Vent Filters address this common problem without sacrificing flow or retention.*

*image for illustrative purposes only

Availability

GORE Sterilizing-Grade Vent Filters are available in packs of 10 and 100 vent filters each.

Please contact us for ordering information.

Part Number Quantity
10870101-010 10 / pack
10870101-100 100 / pack

 

Efficient Design, Improved Performance

Gore offers unparalleled expertise in expanded polytetrafluoroethylene or ePTFE, an extremely strong, durable polymer that we use to power our vent filters. With our expertise, we’re able to engineer ePTFE membranes to possess performance characteristics that deliver.

Common Applications

GORE Sterilizing-Grade Vent Filters meet requirements for use in a variety of sterile environments. They’re commonly used for venting or in-line filtration applications involving:

  • bioreactors
  • shaker flasks
  • carboys
  • holding, storage or transfer vessels
  • vessel and bottle assemblies

Applied in non-GMP, pre-GMP, or GMP-regulated environments, the vents are commonly used to work with:

  • monoclonal antibodies (mAbs)
  • recombinant proteins
  • vaccines
  • conjugates
  • growth factors
  • plasma-derived products

Product Comparison

A Smaller, Smarter Solution

Commonly used 50 mm vent filters are heavy, causing tubing to kink and reduce or block airflow, which can lead to losses during processing. Typical 50 mm vent filters also take up a lot of space, making them difficult to manage in tight areas. Smaller, lighter-weight GORE Sterilizing-Grade Vent Filters virtually eliminate kinking while their small size helps reduce clutter in the work area.

Typical 50 mm Vent Filter

typical 50 mm vent filter

Typical 50 mm vent filter

Weight (nominal)
17 - 38 grams

Effective Filtration Area (nominal)
20 cm2

GORE Vent Filter

GORE Vent Filter

GORE Vent Filter

Weight (nominal)
4.2 grams

Effective Filtration Area (nominal)
5.4 cm2

The Difference is in the Membrane
A close look at the GORE Membrane

A close look at the GORE™ Membrane

GORE Sterilizing-Grade Vent Filters provide airflow rates you’d expect from a filtration membrane area many times larger. In fact, our vent filters offer the airflow of other commercially available 50 mm vent filters — but in a smaller, lighter-weight package.

This performance is made possible by the superior high-flow, sterilizing-grade expanded polytetrafluoroethylene (ePTFE) membrane in each filter. Gore is the world leader in understanding ePTFE and its capabilities; we’re able to use that expertise to engineer the membrane to deliver the high-quality performance our customers expect.

Product Information

Materials of Construction

  • Housing (lid and base): Polypropylene
  • Filter material (laminate): Expanded polytetrafluoroethylene (ePTFE) membrane with polypropylene non-woven

The Effective Filtration Area (EFA) is 5.4 cm2.

Expanded view of GORE Vent Filter
Comparison of Typical Airflow Performance
Graph comparing typical airflow performance
Performance Specifications
Liquid Bacteria Retention Retains a minimum challenge concentration of 1 x 107 cfu/cm2 of aerosolized Brevundimonas diminuta using a method based on ASTM F838-05
Aerosol Bacteria Retention Retains a total challenge of least 1 x108 cfu aerosolized Brevundimonas diminuta per device
Bubble Point Equal to or greater than 12.8 psi (883 mbar) in 70/30% (v/v) mixture of isopropyl alcohol and water
Integrity Test 100% tested prior to release
Biocompatibility USP <87> Biological Reactivity Tests In-Vitro
USP <88> Biological Reactivity Tests In-Vivo, Plastics Class VI
Physicochemical USP <661> Containers — Plastics, Physicochemical Tests
Particulates USP <788> Particulate Matter in Injections for Large Volume Parenterals
Bacterial Endotoxin USP <85> Bacterial Endotoxin limits

Detailed test information is available in the GORE Sterilizing-Grade Vent Filter Validation Guide, available upon request.

Operation
Recommended Use 0.25-inch (6.4 mm) inner-diameter tubing
Operating Temperature 2°C – 40°C (36°F – 104°F)
Maximum Differential Pressure 35 psid (2.4 bar), forward or reverse
Maximum Inlet Pressure 40 psig (2.8 bar), forward or reverse
Sterilization

Maximum of three autoclave cycles for 30 minutes at 135°C (275°F).

Note: Irradiation sterilization methods such as gamma or electron beam should never be used as they may damage or degrade the mechanical and barrier properties of the product.

Compliance & Quality
check mark

Gore is committed to providing our customers with rigorously compliant products that deliver high-quality performance over time. GORE Vent Filters are manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP) as defined in the Gore PharmBIO Products' quality system which is certified to ISO 13485 and ISO 15378. 

A Certificate of Compliance accompanies each shipment of GORE Sterilizing-Grade Vent Filters.

For more information or to read our most current compliance statements, please contact us.

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