Solvay's Udel P-1700 PSU resin offers superior performance for TBL's sight gauges used in pharma.
After trials with polycarbonate (PC) resin failed, TBL, a manufacturer of single-use, bio-process components and systems, turned to Solvay’s transparent Udel P-1700 PSU resin to achieve superior strength, transparency, heat resistance, hydrolytic stability and retention of mechanical properties under steam sterilization for demanding biopharmaceutical processing conditions.
“Solvay takes a highly proactive approach to material testing to support the regulatory compliance needs of pharma industry customers,” said Anna Maria Bertasa, global marketing manager – healthcare for Solvay’s Specialty Polymers global business unit. “Our value-added services enhance our high-performance polymers and support biopharma processing trends such as the increased adoption of single-use components. By delivering on all the stringent requirements of TBL’s Tri-Clamp sight gauges, Udel PSU resin demonstrates how critically important material technologies are to this fast-changing and demanding sector.”
In addition to transparent Udel P-1700 PSU resin, which is extruded into the single-use tubular sight gauges, TBL chose an opaque, white grade of Udel PSU resin to create the connection between the sight gauge and the tubing used in various critical bio-processing applications. This product is over-molded onto the sight gauge to form a secure and hygienic gasket that is affixed with a mechanical clamp.
“Udel P-1700 PSU resin is a major breakthrough for the pharmaceutical industry,” said Robert DuPont, managing director of operations for TBL Performance Plastics. “One key factor in choosing Udel P-1700 PSU resin is the incredibly rigorous regulatory testing done by Solvay, particularly for extractables and leachables under the BioPhorum Operations Group (BPOG) standard. Solvay has taken a lead position in providing this data to its customers. Based on the exceptional performance of Udel PSU resin and our productive collaboration with Solvay, we are planning to expand the use of this material into novel products currently under development.”
These Solvay materials are animal-derived component free (ADCF) and meet USP Class IV and ISO 10993 requirements for biocompatibility.
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) resins. These materials can be used in a range of applications in these sectors such as filtration media and housings, components and instruments, as well as fluid and storage management systems.