Extractables and Leachables
Boston Analytical has the experience to determine if any component that comes in contact with your drug product, when exposed to stressed conditions (extractables), or from regular use over time (leachables), will have a negative impact on your product. Additionally, if you are a manufacturer, Boston Analytical will determine conformance for single use systems and other manufacturing components. This is a crucial step of the filing of drug products with the FDA, and the results of this testing also can provide useful insights into how compounds may affect human health. With over 30 years of combined experience, our team is ready to assist you in your extractable and leachable needs.
BPOG Protocol Testing
Boston Analytical is well versed in the BPOG protocol, “Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing.” We can help you navigate the protocol and develop strategies to meet compliance requirements. Our extractable and leachable testing labs feature the latest advancements in methodology and equipment to ensure the best overall results.
The Boston Analytical risk assessment process involves evaluating the leachables risk for the packaging, processing component, or medical device. Our team includes experts who know the entire FDA approval and review process and can provide comprehensive guidance concerning the risk. This risk is outlined in a comprehensive report that includes a test plan outline to address the risk. With this information at hand you can make the adjustments necessary to be certain that your products are patient ready.