Curated News
By: NewsRamp Editorial Staff
December 04, 2025
AdvantaPure Leads with Early USP 665 Compliance for Safer High-Purity Products
TLDR
- 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.
Impact - Why it Matters
This news is crucial because it directly affects safety and reliability in industries like pharmaceuticals and biopharma, where extractables and leachables can compromise product integrity and patient health. By achieving early compliance with USP 665, AdvantaPure sets a higher standard for risk assessment in single-use systems, potentially reducing contamination incidents and enhancing regulatory confidence. For end-users, this means access to cleaner, safer fluid transfer options, which can accelerate product development and reduce costs associated with compliance delays. In a market driven by stringent regulations, such proactive measures can influence industry practices, fostering innovation and trust in high-purity technologies.
Summary
AdvantaPure, a division of NewAge Industries, Inc., has announced its full and early compliance with the USP 665 guideline, positioning itself as a leader in the high-purity fluid transfer market. The company, a global leader in manufacturing tubing, hose, and high-purity fluid transfer accessories, has proactively met the regulatory standards that transition from the guidance originally established by the BioPhorum Operations Group (BPOG) to the United States Pharmacopeia (USP) requirements. This compliance specifically addresses the identification, characterization, and risk assessment of extractables and leachables in plastics products, including single-use systems, ensuring safety and efficacy in product development. The mandate for full compliance by May 1, 2026, makes AdvantaPure's early adherence a significant milestone, demonstrating its commitment to regulatory excellence and customer safety.
The core message from AdvantaPure emphasizes its dedication to providing the cleanest and best options with the lowest risk to end users, as highlighted by CEO Mary Marcus, who expressed excitement about implementing this standardized approach. The products covered include AdvantaSil APST, APSH Liner, APSW, APSPG, and APHP, along with AdvantaFlex APAF and Liquid Injection Molding (LIM) 6050 materials, all used in high-purity pharmaceutical, biopharma, and industrial markets. As an ISO-9001 certified, 100% employee-owned corporation with a Platinum EcoVadis Sustainability Rating and Certified B Corporation status, NewAge Industries underscores its corporate responsibility and innovation in fluid transfer systems solutions. This news matters because it showcases AdvantaPure's proactive stance in a highly regulated industry, potentially setting a benchmark for competitors and reassuring clients about product integrity.
In the broader context, this announcement impacts the high-purity market by enhancing trust in single-use systems and components, which are critical for industries like pharmaceuticals where contamination risks must be minimized. By incorporating the anchor text "high-purity fluid transfer accessories" into its compliance efforts, AdvantaPure reinforces its role as a key player in advancing safety standards. The company's operations from locations in Southampton, PA, Warrington, PA, and Coevorden, Netherlands, further highlight its global reach and commitment to quality. Overall, this development not only meets regulatory demands but also drives innovation in product safety, benefiting end-users through reduced risks and improved reliability in fluid transfer applications.
Source Statement
This curated news summary relied on content disributed by 24-7 Press Release. Read the original source here, AdvantaPure Leads with Early USP 665 Compliance for Safer High-Purity Products
