AdvantaPure Achieves Full USP 665 Compliance Ahead of 2026 Deadline

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 plastic products, well ahead of the May 1, 2026 regulatory deadline. This early compliance positions the company as a leader in safety standards for high-purity fluid transfer systems used in pharmaceutical and biopharmaceutical manufacturing.

The USP 665 guideline establishes standardized requirements for identifying, characterizing, and assessing the risk of extractables and leachables—chemical substances that can migrate from plastic materials into fluids—in products used in high-purity applications. This regulatory framework replaces previous guidance from the BioPhorum Operations Group (BPOG) and represents a significant advancement in product safety protocols for the industry.

AdvantaPure's compliance covers multiple 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 has also achieved compliance for its Liquid Injection Molding (LIM) 6050 material used in components and custom overmolding applications. These products are critical components in single-use systems that have become increasingly prevalent in pharmaceutical manufacturing due to their efficiency and reduced contamination risk.

"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 of AdvantaPure.

The importance of this compliance extends beyond regulatory adherence. For pharmaceutical and biopharmaceutical companies, the standardized testing protocols mean greater confidence in product safety and reduced risk of contamination during drug manufacturing. This is particularly crucial for sensitive biologics and other advanced therapies where even trace contaminants can compromise product efficacy or patient safety.

NewAge Industries, the parent company of AdvantaPure, operates as 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 administers its various product lines from locations in Southampton, PA, Warrington, PA, and Coevorden, Netherlands, serving global markets with fluid transfer solutions made from materials including silicone, TPE, and rubber.

For more information about AdvantaPure's products and compliance, visit https://www.advantapure.com. Additional details about NewAge Industries can be found at https://www.newageindustries.com.

The early compliance announcement comes as the pharmaceutical industry prepares for the mandatory implementation of USP 665 standards next year. Companies that have already achieved compliance, like AdvantaPure, provide their customers with a significant advantage by eliminating uncertainty about product safety data and ensuring continuity in manufacturing processes. This development represents a meaningful step forward in standardizing safety protocols across the global pharmaceutical supply chain, potentially reducing regulatory hurdles and improving patient safety outcomes.