Solvay’s Udel® PSU enabled Nordson MEDICAL to develop its Spaulding Series™ Aseptic Disconnects for pharmaceutical and bioprocessing. Udel® P-1700 polysulfone (PSU) was chosen for the new series of bioprocess fittings due to its biocompatibility, transparency, strength and rigidity, broad temperature range and compatibility with gamma radiation (up to 50 kGy) and steam sterilization. These innovative connectors are on display in Solvay’s booth at BioProcess International 2019 being held at the Boston Convention and Exhibition Center (BCEC) in Boston, Mass.
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Solvay’s high-performance Udel® polysulfone (PSU) enabled Nordson MEDICAL to develop its Spaulding Series™ Aseptic Disconnects for pharmaceutical and bioprocessing of liquids. Spaulding Series™ Aseptic Disconnects provide a leak-free connection, eliminating the need for pinch clamps and tube welders. |
Udel® P-1700 PSU readily withstands the required operating temperature range of -40°C to 138°C (-40°F to 280°F), enabling the aseptic disconnects to be used in cryogenic conditions and be steam sterilized. The material’s transparency allows processors to observe the flow of liquid through the connectors, and its combination of high heat resistance and hydrolytic stability provide an important advantage over polycarbonate (PC), which is highly susceptible to stress cracking. Udel® P-1700 PSU is animal-derived component free (ADCF), and it meets USP Class IV requirements for biocompatibility. In addition, components can be molded to tight tolerances with minimal flash and scrap.
“Adopting Solvay’s high-performance Udel® PSU meant a significant shift from the polyolefins we’ve historically used,” said Ken Davis, global product line manager for biopharmaceuticals at Nordson MEDICAL. “Solvay’s technical support and processing guidance made the transition to this new material smooth and easy. It’s performing beautifully and we look forward to future collaborations with Solvay on other products.”
The Spaulding Series™ Aseptic Disconnects provide a leak-free connection, eliminating the need for pinch clamps and tube welders. Smooth disconnects are achievable with the easy-to-use design, and valuable fluids are protected by valves that automatically shut off flow when the fittings are disconnected. Validation and test results confirm their suitability in pre- and post-sterilized systems. The connectors are well suited for processing biopharmaceuticals, vaccines and active pharmaceutical ingredients.
“Solvay is committed to supplying next-generation polymers to support advancements in bioprocessing, cell and gene therapies and pharmaceutical processing,” said Eva Heintz, global marketing manager for Healthcare at Solvay’s Specialty Polymers global business unit. “By serving as a true partner to companies like Nordson MEDICAL, Solvay helps to match key material attributes to specific application requirements.”
Solvay offers a broad selection of high-purity, specialty polymers for pharmaceutical and bioprocessing technologies. Products include Udel® PSU, Veradel® HC polyethersulfone (PESU), Radel® polyphenylsulfone (PPSU), Ixef® polyarylamide (PARA), KetaSpire® polyetheretherketone (PEEK) and AvaSpire® polyaryletherketone (PAEK). Typical applications include filtration media and housings, components and instruments, as well as fluid and storage management.
®Udel, Veradel, Radel, Ixef, KetaSpire and AvaSpire are registered trademarks of Solvay
™Spaulding Series is a trademark of Nordson MEDICAL
