Solvay's Udel® PSU (Polysulfone) material enables Nordson MEDICAL to develop the Spaulding Series ™ sterile connectors for biopharmaceutical processing. Udel® P-1700 PSU (polysulfone) was selected for new biopharmaceutical production components due to its excellent biocompatibility, transparency, strength and rigidity, and a wide operating temperature range, which can withstand gamma radiation (up to 50 kGy) and repeated steam sterilizations.
Udel® P-1700 PSU (Polysulfone) can withstand an operating temperature range of -40 ° C to 138 ° C (-40 ° F to 280 ° F), making sterile connectors suitable for both low temperature conditions and High-temperature steam sterilization. The transparent appearance of the material allows the operator to observe the flow of the liquid through the connector, and its excellent heat resistance and hydrolytic stability are significantly better than polycarbonate (PC), which is susceptible to stress cracking. Udel® P-1700 PSU ((polysulfone) is free of animal-derived ingredients (ADCF) and meets USP Class IV biocompatibility requirements. In addition, the tolerance for injection molding of components is small, which can minimize burrs And waste generation.
"We have always used polyolefin-based materials. For us, the use of Solvay's high-performance Udel® PSU (polysulfone) material is a major change (polysulfone). Global Product Line Manager, Bioson Pharmaceuticals, Nordson MEDICAL Ken Davis said, "Solvay's technical support and processing guidance made the transition of the material smooth and easy. The new material has performed very well, and we look forward to working with Solvay again on other products in the future."
Spaulding Series ™ Aseptic Connectors enable leak-free connections, eliminating the need for clamps and tube welders. And the design is light and easy to plug and unplug. When the connector is disconnected, the valve will automatically close to protect important fluids. Tests and verification results confirm that the connector can work properly before and after sterilization, making it an ideal choice for processing biopharmaceuticals, vaccines, and active pharmaceutical ingredients.
"Solvay is committed to providing next-generation polymers to support advances in biopharmaceuticals, cell and gene therapy, and chemical pharmaceutical processing," said Eva Heintz, Global Medical Market Manager, Solvay Specialty Polymers. In collaboration with Nordson MEDICAL, Solvay is committed to providing material solutions for specific application needs. "
Solvay offers a wide selection of high-purity specialty polymers for pharmaceutical and bioprocessing technologies, including Udel® PSU (polysulfone), Veradel® HCPESU (polyethersulfone), Radel® PPSU (polyphenylsulfone), Ixef® PARA ( Polyarylamide), KetaSpire® PEEK (polyetheretherketone) and AvaSpire® PAEK (polyaryletherketone). Typical application examples include filtration membranes and housings, components and tools, and fluid and storage bags.