AdvantaPure Achieves Full USP 665 Compliance Ahead of 2026 Deadline for Pharmaceutical Products
TL;DR
AdvantaPure gains a competitive edge by achieving full USP 665 compliance early, ensuring its high-purity tubing and components offer the cleanest, lowest-risk options for industry partners.
AdvantaPure's compliance involves identifying and assessing extractables and leachables in specific silicone and TPE products, following USP 665 guidelines to ensure material safety and efficacy.
This compliance enhances product safety in pharmaceuticals and biopharma, reducing contamination risks and protecting end-users, contributing to a healthier and more secure future.
AdvantaPure, a 70-year-old employee-owned company, now meets strict USP 665 standards for extractables and leachables in its high-purity fluid transfer systems ahead of the 2026 deadline.
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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 compliance demonstrates AdvantaPure's proactive approach to regulatory changes that affect global supply chains for critical healthcare products.
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 announcement matters because it provides pharmaceutical and biopharmaceutical manufacturers with critical assurance about the safety profiles of fluid transfer components as regulatory standards evolve.
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. Companies using compliant products can streamline their validation processes and reduce potential contamination risks in sensitive manufacturing environments.
"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. 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®. More information about the company's sustainability initiatives can be found at https://www.newageindustries.com.
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. This regulatory achievement positions AdvantaPure to better serve manufacturers who require documented compliance with evolving standards for product safety in sensitive applications where contamination risks must be minimized through rigorous material testing and validation protocols.
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