Solvay has unveiled a broad portfolio of medical-grade specialty polymers for single-use biopharmaceutical manufacturing applications. Encompassing select grades from five of its most recognized product families, Solvay’s portfolio aims to support the industry’s shift toward single-use peripherals, filtration, bioreactors and containment. In more practical terms, it will help biopharmaceutical manufacturers achieve greater flexibility, faster product development, reduced capital costs and increased speed to market.
The five product families from which Solvay assembled its new biopharmaceutical manufacturing portfolio include:
• Radel® polyphenylsulfone (PPSU)
• Udel® polysulfone (PSU)
• AvaSpire® polyaryletherketone (PAEK)
• KetaSpire® polyetheretherketone (PEEK)
• Ixef® polyarylamide (PARA)
In qualifying materials for single-use applications, Solvay evaluated the effect of gamma irradiation up to 50 kGy on each polymer to ensure it would retain excellent mechanical performance and other application-critical properties. Results confirmed each material’s compatibility with gamma irradiation, the preferred sterilization method for single-use systems.
All materials are certified under United States Pharmacopeia (USP) Class VI test standards – before and after gamma irradiation – to ensure they meet stringent industry requirements. Solvay is also following industry guidelines to evaluate leachables and extractables for its biopharma portfolio.