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Smithers provides extractables and leachables (E&L) testing to help pharmaceutical and biopharmaceutical manufacturers assess plastic components used in manufacturing systems. Our testing capabilities support USP 665 requirements and risk-based component qualification.
Need support with USP <665> testing? Contact Smithers to discuss your components and testing requirements.
What Is USP <665>?
USP <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, provides a risk-based framework for assessing plastic components that contact liquid or semisolid process streams. Official as of May 1, 2026, the chapter addresses potential process equipment-related leachables (PERLs) that may migrate into manufacturing process streams and affect drug product quality.Test Capabilities
Smithers supports USP <665> implementation with analytical testing based on component risk classification. Capabilities include:- Nonvolatile residue (NVR) testing and UV absorbance: Screen low-risk components.
- Organic extractables profiling: Characterize compounds from moderate- and high-risk components.
- Multisolvent extraction studies: Evaluate high-risk components under organic, acidic, and basic conditions.
- Extracted elements testing: Assess elemental extractables where appropriate.
- Leachables assessment: Evaluate potential migration into drug substances or drug products.
Components Tested
USP <665> covers plastic components used in single-use and multiple-use manufacturing systems that contact liquid or semisolid process streams. Examples include:- Tubing and fluid transfer systems
- Storage containers, bags, bottles, and closures
- Bioreactors and mixing bags
- Filters and filtration cassettes
- Chromatography column housings
- Connectors and filling needles
- Ancillary polymeric components, such as diaphragms
Expert Support for USP Testing
USP <665> implementation requires appropriate risk assessments, extraction study design, and interpretation of analytical results. Smithers E&L specialists support manufacturers from test strategy development through extractables characterization and leachables assessment, helping inform component qualification and manufacturing decisions.Need support with USP <665> testing? Contact Smithers to discuss your components and testing requirements.
