TAGS: Medical High Heat Materials Transparency
TBL, a manufacturer of single-use, bioprocess components and systems, has used Solvay’s transparent Udel® P-1700 PSU resin for its sight gauges used in pharma. The resin can help TBL achieve superior strength, transparency, heat resistance, hydrolytic stability and retention of mechanical properties under steam sterilization for demanding biopharmaceutical processing conditions.
Regulatory Compliant Product for Pharmaceutical Industry
Udel® P-1700 PSU resin is a breakthrough for the pharmaceutical industry. 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.
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Solvay has taken a leadership 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,” said Robert DuPont, managing director of operations for TBL.
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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.
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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.”
Udel® PSU Resin for Bioprocessing Applications
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 bioprocessing applications. This product is over-molded onto the sight gauge to form a secure and hygienic gasket that is affixed with a mechanical clamp.
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. 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.
Source: Solvay