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 adherence matters significantly as it provides manufacturers with critical assurance about the safety profiles of fluid transfer components during a period of evolving regulatory standards, enabling companies to streamline validation processes and reduce potential contamination risks in sensitive manufacturing environments.
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. 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.
"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's importance extends beyond mere regulatory checking; it represents a proactive stance in a sector where material safety directly impacts drug efficacy and patient health. Companies utilizing these compliant products can potentially accelerate their time-to-market for new therapies by simplifying documentation and reducing uncertainty during regulatory submissions.
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. This early compliance demonstrates AdvantaPure's commitment to anticipating and adapting to regulatory changes that affect global supply chains for critical healthcare products, potentially setting a benchmark for competitors and reinforcing supply chain reliability for manufacturers facing stringent quality demands.
