AdvantaPure Achieves Full USP 665 Compliance for High-Purity Fluid Transfer Products

AdvantaPure, a division of NewAge Industries, Inc., has achieved full compliance with the United States Pharmacopeia (USP) 665 guideline for identifying, characterizing, and assessing extractables and leachables in its plastics products. This compliance comes well ahead of the May 1, 2026, deadline mandated for the high-purity market, positioning the company as an early adopter of these critical safety standards.

The USP 665 guideline represents a significant regulatory transition from previous guidance established by the BioPhorum Operations Group (BPOG). It specifically addresses the reporting of extractables and leachables data for products used in pharmaceutical and biopharmaceutical applications. Extractables are chemical compounds that can migrate from materials under exaggerated conditions, while leachables are those that migrate under normal conditions of use. Both present potential risks to product safety and efficacy, particularly in single-use systems where direct contact with sensitive biologics or pharmaceuticals occurs.

AdvantaPure's compliance covers multiple product lines and materials. The AdvantaSil series, including APST – NI-201, APSH Liner and APSW – NI-202, APSPG – NI-205, and APHP – NI-210, all in extruded forms, meet the new standards. The AdvantaFlex APAF – P50102-64, available in both extruded and molded versions, is also compliant. Additionally, Liquid Injection Molding (LIM) 6050 – NI-206 (LSR) material for components and custom overmolding applications is included. This comprehensive coverage ensures that a wide range of tubing, hose, and fluid transfer accessories used in critical processes adhere to the heightened safety protocols.

Mary Marcus, CEO of AdvantaPure, emphasized the importance of this achievement. "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," she stated. This proactive stance reflects the company's commitment to advancing product safety and reliability in sectors where contamination risks must be minimized.

The implications of this early compliance are substantial for the pharmaceutical and biopharma industries. By adhering to USP 665, AdvantaPure helps manufacturers mitigate risks associated with extractables and leachables, which can compromise drug purity, patient safety, and regulatory approvals. This is especially crucial as the industry increasingly adopts single-use technologies to enhance flexibility and reduce cross-contamination. Compliance supports smoother regulatory submissions and reduces potential delays in product development cycles, ultimately benefiting end-users through safer therapeutic products.

NewAge Industries, Inc., the parent company, brings over 70 years of experience in designing, manufacturing, and distributing fluid transfer systems. As an ISO-9001 certified, employee-owned corporation with a Platinum EcoVadis Sustainability Rating and Certified B Corporation status, it underscores a broader commitment to quality and environmental responsibility. The company operates from locations in Southampton, PA, Warrington, PA, and Coevorden, Netherlands, managing brands like AdvantaPure, AdvantaFlex, AdvantaSil, and BioClosure container closure systems. More information about their initiatives can be found at https://www.advantapure.com.

This announcement highlights AdvantaPure's leadership in meeting evolving regulatory demands, providing industry partners with compliant solutions that enhance safety and efficiency in high-purity applications.