GORE® Life Sciences Venting
Optimize your process with GORE® Microfiltration Media, engineered to enhance performance, reliability, and purity across diverse industries.
High Performance Media for Life Critical Applications
In almost all healthcare equipment applications, including bedside or wearable, venting and filtration capabilities are critical to the successful operation of the equipment. Effective venting requires high gas permeability. It is the gas permeability of the media that enables high airflow, fast pressure equalization. Filtration solutions protect equipment from contamination during use by enabling gas to pass through with low pressure drop while providing a barrier to liquids, aerosolized liquids, microbes, and particles.
Gore has been developing high performance media including expanded polytetrafluoroethylene (ePTFE) membranes to solve the design challenges faced by device engineers for more than four decades. We are not just a supplier of membranes — we are a trusted partner that collaborates closely with device development teams to design a solution that addresses the unique challenges of your device and end-use environment. Based on individual requirements, Gore engineers will assist in the selection of the best material for our customer’s applications based on various material properties, such as density, porosity, thickness, and surface characteristics.
Versatility and Customization
GORE Microfiltration Media are constructed with a proprietary expanded polytetrafluoroethylene (ePTFE) membrane backed by various support layers. They deliver superior performance in non-implantable medical devices, whether the need is venting, moisture control, pressure equalization, or filtration efficiency as measured by bacterial filtration efficiency (BFE) or viral filtration efficiency (VFE).
Highly customizable, GORE Microfiltration Media are available with hydrophobic or oleophobic properties and can be made with a variety of non-woven support layers. They can be engineered in rolls with custom slit widths or to fit custom die cut parts. Actual product design is based on customer requirements. We design each vent specifically for its application. Once the vent is built, we thoroughly test it in real world conditions. As a result, vents are designed to perform to specifications — the first time and every time — and deliver outstanding performance.
Outstanding Performance
GORE Microfiltration Media deliver superior performance, ranging from high airflow to high retention, in an expanding family of non-implantable devices. All of your key performance characteristics can be balanced carefully to meet the specific requirements of your application.
The following table lists the range of performance for selected product characteristics of GORE Microfiltration Media.
Engineered for Life Sciences
Gore maintains adherence to our disciplined quality system to ensure we meet rigorous standards for life science products:
- ISO 13485 certification
- Products manufactured under relevant cGMP
- Cleanroom monitoring program equivalent to that which is required for ISO class
- Products controlled by designated Design History File
In addition, the GORE Microfiltration Media portfolio of products meets the applicable biological evaluation tests described in BS
EN ISO 10993-4, -5, -10, -11, and -23 as relevant for medical devices.
| GORE Microfiltration Media Performance Ranges Based on typical mean product performance characteristics Ranges vary between constructions | |
|---|---|
| Airflow, typical [l/h @12 mbar @2.99 cm2] | 4 to 288 |
| WEP, typical [kPa] | 68 to 1897 |
| Thickness, typical [mm] | 0.21 to 0.23 |
| BFE/VFE [%] | up to 99.9999999 |
| Nominal Pore Size [µm] | 0.03 to 5 |
Liquid Entry Pressure (LEP) / Airflow Performance Requirements of Various Applications
The following graph shows suitable and common applications for the individual material classes based on airflow and liquid retention needs.
GORE Microfiltration Applications
Infusion
GORE Microfiltration Media for Infusion allows medical device manufacturers to design IV filters with reliable micro-gas bubble evacuation that contains fluids and maintains sterility. It consistently delivers high performance and enables a stable integration process for high volume production, unlike other materials.
Drug Preparation
GORE Microfiltration Media for Drug Preparation helps protect healthcare workers from exposure during the compounding and administration of hazardous drugs. It is highly inert and engineered to contain aggressive reagents and solvents compared to other materials, making it the preferred choice when it comes to designing reliable closed system transfer devices (CSTD).
Diagnostics
GORE Microfiltration Media for In Vitro Diagnostics helps design engineers and program managers at OEMs and CDMOs develop molecular diagnostic (MDx) panels with consistent and precise fluid movement thus enabling accurate and reliable test results. Unlike other filter or vent options, Gore’s vent solutions are engineered to work with aggressive reagents and solvents giving more freedom in cartridge design while enabling more cost-effective designs.
Negative Pressure Wound Therapy
GORE Microfiltration Media for Negative Pressure Wound Therapy (NPWT) acts as a filter that helps design engineers of medical device manufacturers enable proper functionality and longevity of NPWT systems. It provides exudate containment and aerosol filtration as well as better functioning of the equipment’s control units compared to other barrier materials.
Ostomy
GORE Microfiltration Media for Ostomy Pouches mitigates vent leakage and pouch ballooning thanks to its high liquid entry pressure, high airflow, and oleophobic treatment, even after fluid contact. Manufacturers also benefit from enhanced production efficiency due to Gore’s repeatable membrane performance and robust supply chain.
Urine Collection
GORE Microfiltration Media for Urine Collection enables unrestricted urine flow in drainage bags and urine meters with its high airflow and inherently hydrophobic venting membranes. Manufacturers also benefit from enhanced production efficiency due to Gore’s repeatable membrane performance and robust supply chain.
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FOR INDUSTRIAL USE ONLY
Not for use in food, drug, cosmetic or medical device manufacturing, processing, or packaging operations.
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