SINGLE-USE SOLUTIONS FOR FLUID PATH SYSTEMS

Pioneering Innovation SOLUTIONS FOR THE BIOPHARMACEUTICAL INDUSTRY The biopharmaceutical industry plays a critical role in the healthcare ecosystem, developing innovative treatments and therapies for a variety of diseases and conditions. New solutions require efficient drug discovery, the ability to quickly scale-up production, and the competency to adapt to an ever-changing world. To ensure patients receive the therapies they need to improve their lives, technology to develop more effective biopharmaceuticals and optimize the efficiency of manufacturing processes is required. Comprehensive integrated...

Accelerate the Advancement of Life-Changing Therapies • Solutions range from individual single-use components to assemblies and full biopharmaceutical systems BioPharmaPro™ from Trelleborg Medical Solutions is a family of innovative products, materials and services for fluid path single-use equipment. These solutions are created using a vast portfolio of materials, including thermoplastics, silicones, and composite materials, which can be manufactured into tubing, custom molded components, processing columns, filters, full assemblies, and much more. • Full portfolio of polymer materials, which...

Expertise at Your Service ACTING AS AN EXTENSION OF YOUR TEAM, OUR DEDICATED RESOURCES DELIVER VALUE THROUGH A STRONG SET OF CORE CAPABILITIES. Because single-use systems perform critical functions, we value strong partnerships with our customers to develop innovative solutions and ensure the best possible outcome. When customers approach us with their ideas for innovative components and devices, we collaborate with them at every step to turn these ideas into reality. Innovative Engineering Advanced Manufacturing Quality Assurance Material Expertise 4 ˙ TRELLEBORG MEDICAL SOLUTIONS

POLYMER MATERIAL EXPERTISE Trelleborg Medical Solutions engineers work closely with customers to design and develop solutions ranging from individual single-use components to assemblies and full biopharmaceutical systems. Collaboration early in the development process accelerates the timeline from prototype to scale-up. When designing new single-use systems, material selection is crucial. Materials must meet functionality requirements, withstand cleaning and sterilization regimens, and comply with standards and regulations. Trelleborg has decades of experience developing, testing, and qualifying...

BioPharmaPro Products & Capabilities ™ Trelleborg Medical Solutions supports biopharmaceutical companies with a full range of products, from single-use tubing and tubing sets and custom molded parts to full assemblies for filtration or chromatography equipment with advanced composite columns. Our facilities utilize automation, in-house tooling, state-of-the-art processing equipment, and cleanroom production to deliver effective, safe, high-quality products and solutions. 6 ˙ TRELLEBORG MEDICAL SOLUTIO

BioPharmaPro™ SILICONE TUBING BioPharmaPro™ silicone tubing is manufactured using platinum-cured silicone, to achieve the highest level of purity. Extended extractable and leachable studies following the BioPhorum Operations Group (BPOG) testing protocol reflect the outstanding cleanliness of BioPharmaPro™ silicone tubing. It comes with United States Pharmacopeia (USP) 87, USP 88 Class VI compliance and can be sterilized with the latest gamma and X-ray sterilization methods to achieve the standards needed in today’s single-use systems. Available in 25 ft/7.62 m, 50 ft/15.24 m, and 100 ft/30.48...

BioPharmaPro™ FITTINGS Customized to each application, BioPharmaPro™ fittings can be manufactured in a range of metal, silicone or thermoplastic materials. They can be supplied as single molded products or together with overmolded silicone tubing, single-braided hose, and double-braided hose. They are suitable for use as sanitary fittings or connectors combined with our BioPharmaPro™ tubing and hose, providing an integrated solution for fluid path and biopharmaceutical applications. BioPharmaPro™ SHEETING Our BioPharmaPro™ sheeting solutions are designed and manufactured with the highest level...

BioPharmaPro™ LSR MOLDED COMPONENTS We produce liquid silicone rubber (LSR) molded components in a stateof-the-art, flashless, wasteless production process, which provides the highest consistency in dimensions, precision, and overall quality. Our lean manufacturing processes can produce almost any design, ranging from microsized components to large-scale pieces. LSR molding enables high-volume production with short cycle times, due to the material’s fast-curing nature. Our in-house tooling and sophisticated process engineering ensure the highest quality and consistently achieved tight tolerances....

Fully Assembled FROM CONCEPT TO SERIAL PRODUCTION Trelleborg Medical Solutions takes the BioPharmaPro™ product and solution portfolio a step further by delivering value-added fluid path assembly solutions. 10 ˙ TRELLEBORG MEDICAL SOLUTIO

INTEGRATED SOLUTIONS • Custom solutions designed to meet unique customer needs • Integrated solutions range from tubing sets for singleuse applications to full equipment assembly, such as chromatography systems • Support from the earliest development stages through to full serial production • Our design and material expertise, paired with simulation technology, facilitates the development of the best design for functional solutions • Supplier consolidation reduces risk in the supply chain • Saves costs through bundled purchasing processes and consolidated audits, shipping and logistics • Rectifies...

BioPharmaPro Materials CONFORMING WITH STRINGENT BIOPHARMACEUTICAL REQUIREMENTS Products designed for biopharmaceutical purposes must fulfill the highest requirements in terms of purity, cleanliness and biocompatibility. Components must be suitable for use with aggressive media and sterilization processes and be inert and non-reactive with cell cultures and media used in drug production. To support customers with the development of new single-use systems, Trelleborg Medical Solutions experts can perform a range of tests to determine the suitability of materials and products. Since risks are high...