Porex medical-grade PTFE is in compliance with USP class VI requirements and is free of animal-derived additives. Its components can be engineered to a specified pore size, volume and structure. The company’s manufacturing platforms are built for reproducibility, which is critical for meeting regulated quality standards. Each Porex medical grade PTFE component is designed and manufactured to function reliably.
Bacterial filtration efficiency (BFE) data has been collected, based on a modified version of ASTM F2101, revealing Porex PTFE medical grades in four application categories: MA grades for sterilization, MB grades for ostomy/urine bags, PMP grades for packaging and MD grades for general medical devices. The standard BFE value for qualified bacterial barrier is 98%, and Porex PTFE well exceeds this, with MD20, MD25, MA10 and MA15 grades boasting >99.9999% BFE values, and other Porex grades with BFE above 99.9%. The MA10 and MA15 grades are also extremely durable as permanent vents in repeated-use autoclave sterilization containers for sterilizing surgical instruments.
How well a medical device works can depend on how well it vents. Porous PTFE vents help improve the quality and performance of medical devices, especially for infection control and fluid management. The table of Porex PTFE with <1–100μm pore size summarizes medical-grade PTFE properties, including BFE, airflow, water entry pressure (WEP) and thickness; for example, MB10/MB10L are used in ostomy bag and urine bag applications, since these grades have high WEP values for leakage control and optimal airflow for efficient venting. The MD grades cover the range of BFE, airflow and WEP values, which serve the various performance requirements of spike vents and IV catheter vents.
• Prevent blood exposure for infection control
• Hydrophobic vent allows airflow but stops blood leakage
• High BFE
• Robust, reusable bacterial barrier as a cost-saving replacement for single-use paper and textile filters for steam sterilization containers
• Serves dual purpose function as a vent to allow pressure equalization during the sterilization process and as a barrier to bacteria during subsequent storage
• Surgical instruments
• Dental instruments
• High-performance hydrophobic vent
• Prevents leakage
• Meets the requirements for water intrusion pressure and airflow
• Hydrophobic vent equalizes pressure differences between the bag’s interior and exterior regions and facilitates expedient disposal of the bag’s contents during draining procedures
• Water intrusion and volumetric airflow design requirements were easily satisfied
• Cap liner vents for bone graft containers
• Sterile barrier with high efficiency venting
• Maintain sterile integrity of bone graft
• High tensile strength, up to 20N/mm2
• Widths: 13mm to 420mm
• Die cut discs (6mm – 300mm) or shapes, available with adhesive backing (6mm – 50mm)
• Wide range of bonding techniques
• Lamination (to backing) as requested
• Customized membranes and molded parts
• Joining by adhesive backing or by vibrational, ultrasonic or heat welding
Porex microporous (PTFE) materials offer a competitive option to expanded PTFE (ePTFE). Porex PTFE is manufactured using a proprietary sintering process that results in an intricate network of open-celled, omni-directional pores that offer exceptional performance and durability on and below the surface. With high tensile properties in all directions, Porex PTFE resists deformation and flex fatigue and does not require a backing or supporting laminate. The inherently stronger Porex PTFE membranes/films can be handled using manual or high-speed equipment. The robust, durable, design-flexible PTFE material can create long-term values.