AdvantaPure, a division of NewAge Industries, Inc., has achieved full compliance with the United States Pharmacopeia (USP) 665 guideline for extractables and leachables testing in its plastics products, including single-use systems. This compliance comes well ahead of the May 1, 2026, deadline mandated for the high-purity market, marking a significant step in product safety and regulatory standardization.
The importance of this announcement lies in the critical role of extractables and leachables data in ensuring the safety and efficacy of pharmaceutical and biopharmaceutical products. Extractables are chemical substances that can migrate from a material under aggressive conditions, while leachables are those that migrate under normal conditions of use. Compliance with USP 665 provides a standardized framework for identifying, characterizing, and assessing the risk of these substances, which is essential for preventing contamination in sensitive processes like drug manufacturing and bioprocessing.
AdvantaPure's compliance covers specific materials used in key product lines, including AdvantaSil APST, AdvantaSil APSH Liner, AdvantaSil APSW, AdvantaSil APSPG, AdvantaSil APHP, and AdvantaFlex APAF in both extruded and molded forms. The Liquid Injection Molding (LIM) 6050 material for components and custom overmolding applications is also included. This broad coverage ensures that a wide range of fluid transfer solutions, from tubing and hose to high-purity accessories, meet the new regulatory standards.
For the pharmaceutical and biopharma industries, this development reduces risk by providing cleaner product options with documented safety profiles. As regulatory standards transition from earlier guidance, such as that from the BioPhorum Operations Group (BPOG), to the formal USP requirements, early compliance by manufacturers like AdvantaPure helps streamline product development and validation for end-users. This is particularly crucial for single-use systems, which are increasingly adopted for their efficiency and reduced contamination risk in bioprocessing.
Mary Marcus, CEO of AdvantaPure, emphasized the company's commitment to this standardized approach, stating it ensures products offer the cleanest options with the lowest risk to end users. As a division of NewAge Industries, Inc., an ISO-9001 certified, employee-owned corporation with a Platinum EcoVadis Sustainability Rating and B Corporation® certification, AdvantaPure's compliance aligns with broader industry trends toward sustainability and quality assurance.
The implications of this announcement extend globally, as AdvantaPure operates from locations in Southampton, PA, Warrington, PA, and Coevorden, Netherlands, serving high-purity markets worldwide. By meeting USP 665 requirements early, the company sets a benchmark for safety and regulatory adherence, potentially influencing industry practices and enhancing trust in fluid transfer systems critical to healthcare and industrial applications.
