ÌìÃÀ´«Ã½

Our USP 665, USP 1665 and BPOG services

• Extractables and Leachables Testing
• Analytical Method Development and Validation
• Characterization of Unknowns
• Risk Assessment
• Consultancy

Extraction studies for single use manufacturing systems

USP <665> testing addresses the evolving landscape of pharmaceutical production, which increasingly relies on polymeric single-use equipment. These standards aim to ensure the safety, efficacy, and quality of pharmaceutical and biopharmaceutical products by providing a framework for characterizing and qualifying plastic components in single-use bioprocessing systems. 
The USP <665> standard details the approach needed for risk assessment and analytical testing of plastic SUS components including extraction procedures and testing methods.

Typical SUS components include;

• Tubing & connectors
• Tank liners & mixing bags
• Sensors & valves
• Elastomeric components e.g. O-rings, gaskets
• Process filters, filtration cassettes & chromatography columns

In 2014 BPOG, a collaboration between global biopharmaceutical and medical device industries , published a proposal outlining standardized methods for extractables testing of SUS components (not including container closure systems) that come into contact with either product or process related fluids during the production of biopharmaceutical products. In 2020 a further guidance document was published providing additional test procedures applicable to both drug substance & drug product manufacturing processes.

As per USP <665> the general approach is based on matrix of model extract conditions simulating a broad range of buffer-based process fluids. The guidelines include a comprehensive test matrix (physical, chemical & biological) cross-referencing methods from USP, EP, ASTM and ISO.

Choose ÌìÃÀ´«Ã½ as your risk management partner for single-use systems (SUS)

Risk management is critical in the lifecycle of SUS to ensure manufacturing processes are safe and compliant and meet the latest regulatory expectations.

ÌìÃÀ´«Ã½ provides a full range of E&L testing services in accordance with the latest regulatory guidelines including ISO 10993, USP <1663> and USP <1664>. Our experts can provide support with study design and consultancy services for all aspects of E&L testing. 

Why Choose ÌìÃÀ´«Ã½?

ÌìÃÀ´«Ã½ brings cutting-edge methodologies, state-of-the-art equipment, and knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.

Our team of engaged experts has directly contributed to the industry for years, serving as active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE, CEN and ISO extractable and leachable best practices.

For more information about our USP 665, USP 1665, BPOG, or to request a quote, contact us today.