What is USP <665>?
USP <665> is a United States Pharmacopeia chapter that establishes standardized requirements for assessing extractables and leachables (E&L) from polymer-based plastic components and systems used in pharmaceutical applications to manufacture pharmaceutical drug and biopharmaceutical drug substances and products. USP < 665 > provides a comprehensive framework for chemical characterization testing.
The U.S. Pharmacopeia (USP) is a nonprofit organization that sets official standards for medicines, food ingredients, and dietary supplements in the United States. It publishes a compendium known as the USP–National Formulary (USP–NF), which contains standards, including specifications for identity, strength, purity, and quality of products to ensure their safety and effectiveness.
E&L Per New USP <665> Guidelines
USP <665> is reshaping how the industry approaches extractables and leachables testing for single-use systems, representing a major advancement in biopharmaceutical manufacturing compliance, risk assessment, and plastic component characterization. It shifts the industry’s focus to a risk-based approach that emphasizes extractables profiling and in-vitro biological testing.
This new chapter sets clear expectations for E&L testing in single-use technologies that ensure product safety, material integrity, and regulatory alignment across upstream and downstream bioprocess operations.
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Supporting USP <665> Compliance with Pendotech Solutions
At Mettler-Toledo Pendotech, we have seen this evolution firsthand. As the industry moves toward stricter E&L compliance and real-time process monitoring, the need for real-time data to support your compliance needs for pressure, UV absorbance, and turbidity is critical.
Our Single-Use Sensors support this shift, providing you peace of mind for your USP <665> compliance needs while also enabling real-time bioprocess analytics, improved process visibility, and confident decision-making in single-use workflows.
To learn more about USP <665> and how it impacts you, click here.
FAQS:
Q: When did USP <665> become effective?
A: USP <665> is scheduled for implementation and will officially become effective on May 1, 2026. Compliance with this standard will then be mandatory.
Q: How do I know if I need to perform this test on my products?
A: USP <665> applies to plastic components and systems used in the manufacture of pharmaceutical drug products and biopharmaceutical drug substances. If your products involve such materials, this testing may be required.
Q: How do I determine my risk level?
A: USP provides a risk-based approach for assessing materials to determine the necessity of extractables and leachables testing. Relevant guidance can be found in USP <665> and its complementary general information chapter, USP <1665> Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug and Biopharmaceutical Drug Substances and Products.
Q: Has Pendotech performed this test?
A: Pendotech is a Single Use (SU) component supplier, it is not a Drug Substance or Product manufacturer, so USP<665> does not apply directly to our products. However, we have performed multiple E&L studies for validation purposes following USP<655> guidelines.
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