AdvantaPure, a division of NewAge Industries, Inc., has announced full compliance with the United States Pharmacopeia (USP) 665 guideline for reporting extractables and leachables data in its plastic products. The company achieved this compliance well ahead of the May 1, 2026, deadline mandated for the high-purity market, which includes pharmaceutical and biopharma applications. This early achievement is significant because it provides manufacturers in these sensitive industries with immediate access to components that meet the latest safety standards, potentially accelerating product development cycles and reducing regulatory hurdles.
The USP 665 standard establishes requirements for identifying, characterizing, and assessing the risk of extractables and leachables in plastic materials used in single-use systems and components. This transition from previous guidance, such as that established by the BioPhorum Operations Group (BPOG), creates a standardized approach to ensure product safety and efficacy during development. The standardization matters because it eliminates variability in testing methodologies across suppliers, giving pharmaceutical companies greater confidence in the consistency and reliability of their supply chain for critical manufacturing components.
AdvantaPure's compliance covers specific materials used in several product lines, including AdvantaSil APST, AdvantaSil APSH Liner, AdvantaSil APSW, AdvantaSil APSPG, AdvantaSil APHP, and AdvantaFlex APAF in both extruded and molded forms. The company's Liquid Injection Molding (LIM) 6050 material for components and custom overmolding applications is also included. This comprehensive coverage is important because it ensures that manufacturers can source multiple component types from a single compliant supplier, simplifying procurement and validation processes for complex fluid transfer systems.
"We are excited to participate in implanting this standardized approach to evaluate extractables and leachables of our high-purity, single-use systems and components to ensure our products, particularly single-use, offer our industry partners the cleanest and best options with the lowest risk to end users," said Mary Marcus, CEO. The announcement matters because it provides pharmaceutical and biopharmaceutical manufacturers with critical assurance about the safety profiles of fluid transfer components as regulatory standards evolve. Companies using compliant products can streamline their validation processes and reduce potential contamination risks in sensitive manufacturing environments.
NewAge Industries, Inc., AdvantaPure's parent company, is an ISO-9001 certified, 100% employee-owned corporation that has earned a Platinum EcoVadis Sustainability Rating and is also a Certified B Corporation®. The company designs, manufactures, and distributes fluid transfer systems solutions in various materials, including silicone, TPE, and rubber, for high-purity pharmaceutical, biopharma, and industrial markets. More information about the company's sustainability initiatives can be found at https://www.newageindustries.com. The early compliance demonstrates AdvantaPure's proactive approach to regulatory changes that affect global supply chains for critical healthcare products. This proactive stance is particularly important as pharmaceutical companies face increasing pressure to accelerate drug development while maintaining stringent quality standards, making reliable, compliant suppliers essential partners in the innovation ecosystem.
