AdvantaPure announces full USP <665> compliance

Published: 16-Jan-2026 Featured companies: AdvantaPure
Regulatory

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, characterise 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 (Moulded)
  • Liquid Injection Moulding (LIM) 6050 – NI-206 (LSR) (Moulded) material for components and custom overmoulding applications is also included.

Shares Mary Marcus, CEO “We are excited to participate in implanting this standardised 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.” 

Featured companies

AdvantaPure™ designs, manufactures, and distributes fluid transfer systems solutions, of a variety of materials, including silicone, TPE, rubber and more, in reinforced and...
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