AdvantaPure™ Announces Full USP 665 Compliance

December 04, 2025 at 03:00 AM EST

Regulatory standards transition with full compliance mandated by May 1, 2026

SOUTHAMPTON, PA, December 04, 2025 /24-7PressRelease/ -- AdvantaPure, a global leader in the manufacture of tubing, hose, and high-purity fluid transfer accessories—and a division of NewAge Industries, Inc.—announces its full and early compliance with the USP 665 guideline to identify, characterize and assess the risk of extractables and leachables in its plastics products, including single-use, to ensure safety and efficacy of product development.

As regulatory standards transition from the guidance originally established by the BioPhorum Operations Group (BPOG) to that outlined by the United States Pharmacopeia (USP), with full compliance mandated by May 1, 2026—specifically to USP 665—regarding the reporting of extractables and leachables data for products used in the high-purity market, the team at AdvantaPure proudly announces full compliance with these requirements for the materials used in the following products:

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)

Liquid Injection Molding (LIM) 6050 – NI-206 (LSR) (Molded) material for components and custom overmolding applications is also included.

Shares Mary Marcus, CEO "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."

In business for over 70 years, NewAge Industries™, Inc. the parent company of AdvantaPure and NewAge Performance Products™, designs, manufactures, and distributes fluid transfer systems solutions, of a variety of materials, including silicone, TPE, rubber and more, in reinforced and unreinforced styles, for the high purity pharmaceutical, biopharma and industrial markets.

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, Inc. administers the activities of their AdvantaPure, AdvantaFlex™, AdvantaSil™, and BioClosure™ container closure systems, and other lines from their corporate headquarters in Southampton, PA U.S, Warrington, PA U.S., and Coevorden, Netherlands locations.

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AdvantaPure™ Announces Full USP 665 Compliance

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