Medical Membrane Materials for OEMs

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Membrane technologies designed for medical applications

Specialized capillary membrane materials support crucial healthcare applications, including blood purification, gas exchange, and therapeutic separation. For OEMs, membrane performance directly affects device reliability, regulatory compliance, and patient outcomes.

Our membranes are used across blood oxygenation, therapeutic apheresis, and other applications in medical devices, where consistent performance and biocompatibility are important. OEMs work with application engineers who offer technical support from device development through commercial production, enabling effective integration of advanced membrane technologies into medical devices.

Addressing challenges of medical device OEM developers

Integrating membrane technologies into regulated medical devices requires alignment across performance and compliance parameters. OEM teams must manage regulatory documentation, maintain batch-to-batch biocompatibility, and balance functional performance with scale-up processes from R&D to commercial manufacturing.

Balancing performance and biocompatibility

Maximizing membrane performance often requires trade-offs with biocompatibility, and vice versa. Membrane design and surface chemistry are engineered to address both, meeting USP and ISO 10993 biocompatibility standards while supporting the performance demands of blood-contacting applications.

Achieving batch-to-batch consistency

Controlled manufacturing processes, such as polymer extrusion parameters, phase-separation conditions, and surface-treatment protocols, help maintain consistent membrane characteristics.

Managing scale-up and commercial production

Manufacturing capabilities spanning lab-scale development samples through high-volume commercial production support OEMs across the product lifecycle. Process transfer, scale-up verification, and capacity planning support membrane quality and compliance through commercialization.

Explore membrane solutions by medical application

Membrane requirements vary significantly based on clinical applications. Medical membrane materials address applications across a range of sectors, with membrane‑based medical separation and exchange processes at their core.

Blood oxygenation membranes

Membrana OXYPLUS Capillary Membranes and Membrana OXYPHAN Capillary Membranes are specialized materials designed for cardiac surgery oxygenators and for extracorporeal membrane oxygenation (ECMO) systems requiring efficient oxygen transfer and carbon dioxide removal during extracorporeal circulation. Membrana OXYPLUS capillary membranes are approved for applications of up to two weeks of continuous operation. Membrana OXYPHAN capillary membranes are used primarily in cardiac surgery oxygenators where reliable gas exchange and handling properties are required. Membrana X30 capillary membranes are designed for gas exchange in medical oxygenators. The small‑diameter capillaries provide high gas permeability, mechanical stability, and dimensional homogeneity for compact oxygenator designs.

Therapeutic apheresis membranes

Membrana MicroPES TF10 Capillary Membrane, Membrana PLASMAPHAN Capillary Membrane, Membrana FractioPES, and Membrana SYNCLEAR Capillary Membranes address the separation and fractionation requirements of therapeutic apheresis procedures. MicroPES TF10 and Membrana PLASMAPHAN Capillary Membranes are intended for primary plasma separation. They separate cell-free plasma from red cells, white cells, and platelets. Membrana FractioPES Membranes are used in a secondary fractionation step to remove targeted plasma constituents, including immunoglobulins and low-density lipoproteins, according to defined sieving coefficient profiles. Membrana SYNCLEAR Capillary Membranes are designed to reduce inflammatory markers and protein-bound toxins, as well as a proportion of the patient's albumin.

Medical device filtration membranes

MicroPES Flat Sheet Membranes and related microporous materials are designed for medical device filtration applications, including IV infusion filters, syringe filters, and in-line disc filters. MicroPES Flat Sheet Membranes are quality-tested for use in IV infusion filter applications and can be processed using common pleating and welding techniques for integration into medical device filter cartridges. Options accommodate diverse integration requirements in medical devices that demand particulate removal, sterile barriers, or controlled fluid processing.

Medical membrane technologies for your processes

Across these applications, membrane architecture and material selection determine performance characteristics.

Medical membrane materials include multiple technology families, pore structures, and materials, such as polyethersulfone, polypropylene, and polymethylpentene that support blood oxygenation, therapeutic apheresis, and filtration applications.

Capillary membranes for medical device applications are produced in several configurations, including bundle, spool, and knitted mat formats, depending on the specific product line. Flat-sheet membranes, by contrast, are frequently incorporated into syringe filters for the sterile filtration of liquids.

Gas exchange

For gas exchange applications, OXYPLUS capillary membranes with a dense outer skin resist plasma breakthrough for ECMO use for up to two weeks. OXYPHAN membranes have a sponge-like structure with uniform pore distribution, which resists plasma infiltration and consistent gas exchange performance. X30 series capillary membranes enable compact oxygenator designs. Membrana HexPET capillaries integrate into heat exchangers for oxygenators.

Biocompatible filtration

Membrana MicroPES membranes are hydrophilic materials manufactured from biocompatible PES with asymmetric pore structures, quality-tested for IV infusion filters. They have a tight, selective layer that enables retention performance, and an open support layer that enables high flow rates. Flat sheet formats support pleating and welding. Capillary formats offer high surface area in compact configurations. Multiple pore size grades are available.

Plasma separation

Membrana MicroPES TF10 capillary membranes are designed for plasma separation in apheresis devices, offering gentle separation of cell-free plasma from cellular components. Hydrophilic surfaces facilitate priming and clinical setup. PLASMAPHAN capillary membranes offer symmetrical pore structures, smooth surfaces, lower complement activation, and demonstrated performance across more than 30 years of clinical use, with ease of processing in potting.

Body temperature management

Membrana HEXPET capillaries are hollow fibers manufactured from polyethylene terephthalate (PET) for use in heat exchanger modules within extracorporeal circuits. Arranged in a knitted mat configuration, these capillaries allow efficient heat transfer between the patient's blood and a temperature-controlled water circuit. Capillaries can be handled in the same manner as gas-exchange membranes during oxygenator manufacturing.

Advancing quality standards and regulatory documentation

Regulatory documentation and quality standards are integral to device approval and commercialization. We're committed to using the highest internationally recognized standards in designing, developing, and manufacturing membranes. Manufacturing is conducted under ISO 13485 quality management standards. OEMs receive Certificates of Conformance (COCs), Certificates of Analysis (COAs), and product data sheets to support regulatory submissions and quality documentation.

Discover OEM resources for membrane materials

Explore a range of technical information, data sheets, case studies, and certificates to support OEM customers throughout the membrane development lifecycle. Resources include product data sheets for both medical and industrial membranes covering physical properties, and performance specifications, as well as certificates and regulatory documents.

Explore resources

Frequently asked questions

Membrane selection depends on application type, required performance specifications, blood contact duration, biocompatibility classification, regulatory pathway, and device manufacturing method. Application engineering specialists evaluate these factors to identify membrane solutions that balance performance and regulatory requirements. Connect with a specialist for application-specific recommendations.

Medical membranes are available in specific pore size ranges, and with sieving coefficient profiles tailored to diverse application requirements. OXYPLUS and OXYPHAN membranes for blood oxygenation feature dense structures designed for gas exchange without plasma penetration. MicroPES TF10 Series and PLASMAPHAN membranes for therapeutic apheresis support plasma separation while retaining cellular components. MicroPES flat sheet membranes for medical filtration are available in graduated pore size ranges. Connect with a specialist for guidance on appropriate selections.

While standard medical membrane materials address the requirements of many medical device OEM programs, customization options include membrane dimensions to meet device integration needs. Application engineering support is available from concept development and feasibility assessment through process optimization, scale-up verification, and commercial manufacturing. Explore other membrane materials for OEMs.

Comprehensive technical documentation is available to support medical device OEM product development and regulatory submissions. Documentation includes detailed product data sheets with complete physical, chemical, and performance specifications, as well as COAs.

Enable process transformations across medical applications

Intended use of the products mentioned on this page vary. For specific intended use statements, please refer to the Instructions for Use for the product.

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