USP 665, USP 1665 and BPOG Services

We provide comprehensive extractables and leachables testing, analytical method development and validation, unknown compound characterization, and detailed risk assessments. Our testing matrix includes physical, chemical, and biological evaluations following USP, EP, ASTM, and ISO methods. We support both container closure systems and broader single-use system components throughout the manufacturing process. 

Additional services we offer include: 

• Extractables and Leachables Testing 

• Analytical Method Development and Validation 

• Characterization of Unknowns 

• Risk Assessment 

• Testing protocol development 

Our testing capabilities cover the complete range of single-use system components, from tubing and connectors to complex filtration systems. We evaluate all materials that come into contact with pharmaceutical products during manufacturing, focusing on extractables and leachables analysis. Our expertise extends to both drug substance and drug product manufacturing processes, ensuring comprehensive coverage of your production chain.

Our approach utilizes a matrix of model extract conditions that simulate various buffer-based process fluids. This includes performing a framework for characterizing and qualifying plastic components in single-use bioprocessing systems. We deliver complete testing programs encompassing extraction studies, analytical testing, and thorough data interpretation to support your regulatory submissions. Our methods align with the latest industry standards and regulatory requirements, including the 2020 BPOG guidance for both drug substance and drug product manufacturing processes. 

Extraction Studies for Single-Use Manufacturing Systems: 
USP <665> focuses on ensuring the safety, efficacy, and quality of biopharmaceutical products by testing polymeric components in single-use systems (SUS). These standards provide guidelines for analyzing plastic components used in bioprocessing, including tubing, tank liners, valves, filters, and elastomers like O-rings. 

In 2014, BPOG introduced standardized methods for SUS extractables testing, and updated guidelines in 2020 for both drug substance and product manufacturing. Testing follows a matrix of simulated process fluids, with methods cross-referenced from USP, EP, ASTM, and ISO standards. 

Our extraction studies include: 

• Strong to moderate solvents 

• High flow & mixing bags 

• Process-relevant contact times 
• Environmental considerations (e.g., O2/He, gamma) 

Single-Use-Systems (SUS) Risk Management: 
Risk management is critical in the lifecycle of SUS to ensure manufacturing processes are safe and compliant and meet the latest regulatory expectations. 

Element provides a full range of E&L testing services under the latest regulatory guidelines, including ISO 10993, USP <1663> and USP <1664>. Our experienced team provides comprehensive testing data needed to meet current requirements and support regulatory approval for your products. 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page. 

Our subject matter experts implement rigorous testing protocols throughout your testing program, from method selection to final data analysis. We conduct complex testing requirements and optimize your path to compliance. Our team includes active participants in PQRI, USP Expert Panels, ELSIE, CEN, and ISO working groups, bringing cutting-edge industry knowledge to your testing projects.