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

AdvantaPure, a division of NewAge Industries, Inc., has announced full and early compliance with the USP 665 guideline for identifying, characterizing, and assessing the risk of extractables and leachables in its plastics products. This compliance applies to materials used in single-use systems and high-purity fluid transfer accessories, aiming to ensure safety and efficacy in product development. The regulatory standards are transitioning from the guidance originally established by the BioPhorum Operations Group (BPOG) to the United States Pharmacopeia (USP) framework, with full compliance mandated by May 1, 2026. AdvantaPure's achievement positions it ahead of this deadline, addressing requirements for reporting extractables and leachables data in the high-purity market.

The products covered by this compliance include AdvantaSil APST – NI-201 (Extruded), AdvantaSil APSH Liner and APSW – NI-202 (Extruded), AdvantaSil APSPG – NI-205 (Extruded), AdvantaSil APHP – NI-210 (Extruded), AdvantaFlex APAF – P50102-64 (Extruded), and AdvantaFlex APAF – P50102-64 (Molded). Additionally, Liquid Injection Molding (LIM) 6050 – NI-206 (LSR) (Molded) material for components and custom overmolding applications is included. This broad range ensures that critical fluid transfer systems in pharmaceutical and biopharma settings meet stringent safety standards. According to CEO Mary Marcus, the company is excited to implement this standardized approach to evaluate extractables and leachables, offering industry partners the cleanest options with the lowest risk to end users.

The implications of this announcement are significant for the high-purity pharmaceutical and biopharma markets, where regulatory compliance directly impacts product safety and market access. By achieving early compliance, AdvantaPure mitigates risks associated with extractables and leachables, which can affect drug efficacy and patient safety. This move aligns with broader industry trends toward standardized testing protocols, as highlighted by resources such as https://www.usp.org, which provides guidelines for pharmacopeial standards. The company's commitment is further underscored by its parent organization, NewAge Industries, Inc., an ISO-9001 certified, employee-owned corporation with a Platinum EcoVadis Sustainability Rating and Certified B Corporation® status.

AdvantaPure's compliance supports the development of single-use systems, which are increasingly vital in biopharmaceutical manufacturing for reducing contamination risks. The early adoption of USP 665 may influence competitors and set a benchmark for quality in fluid transfer solutions. For more information on industry standards, refer to https://www.biophorum.com, which discusses operational guidelines in biopharma. This proactive approach not only enhances product reliability but also strengthens AdvantaPure's position as a leader in high-purity components, contributing to safer and more efficient processes in critical healthcare applications.