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FAQ: AdvantaPure's USP 665 Compliance for High-Purity Fluid Transfer Products
TL;DR
AdvantaPure gains a competitive edge by achieving full USP 665 compliance early, ensuring its high-purity tubing and components offer the cleanest, lowest-risk options for industry partners.
AdvantaPure's compliance involves identifying and assessing extractables and leachables in specific silicone and TPE products, following USP 665 guidelines to ensure material safety and efficacy.
This compliance enhances product safety in pharmaceuticals and biopharma, reducing contamination risks and protecting end-users, contributing to a healthier and more secure future.
AdvantaPure, a 70-year-old employee-owned company, now meets strict USP 665 standards for extractables and leachables in its high-purity fluid transfer systems ahead of the 2026 deadline.
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AdvantaPure announces its full and early compliance with the USP 665 guideline, which involves identifying, characterizing, and assessing the risk of extractables and leachables in its plastics products to ensure safety and efficacy.
Compliance ensures the safety and efficacy of product development, particularly for single-use systems and components in high-purity markets, by standardizing the evaluation of extractables and leachables to minimize risk to end users.
Full compliance with USP 665 is mandated by May 1, 2026, as regulatory standards transition from BioPhorum Operations Group (BPOG) guidance to United States Pharmacopeia (USP) requirements.
The compliance covers materials used in: 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), AdvantaFlex APAF – P50102-64 (Molded), and Liquid Injection Molding (LIM) 6050 – NI-206 (LSR) (Molded) material.
AdvantaPure is a global leader in manufacturing tubing, hose, and high-purity fluid transfer accessories, and a division of NewAge Industries, Inc., which designs, manufactures, and distributes fluid transfer systems for pharmaceutical, biopharma, and industrial markets.
According to CEO Mary Marcus, this standardized approach ensures that products, particularly single-use systems, offer the cleanest and best options with the lowest risk to end users, supporting safer and more effective product development.
NewAge Industries is an ISO-9001 certified, 100% employee-owned corporation (ESOP) that has earned a Platinum EcoVadis Sustainability Rating and is also a Certified B Corporation®.
NewAge Industries administers its activities from corporate headquarters in Southampton, PA U.S., Warrington, PA U.S., and Coevorden, Netherlands locations.
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