EXTRACTABLES &
LEACHABLES

Reliable data from a risk based approach

EXTRACTABLES &
LEACHABLES

Reliable data from a risk based approach

Extractable Studies

Boston Analytical has extensive experience with extractables testing of all forms of drug product packaging, processing components, and medical devices. Our knowledgeable staff can guide you through the regulatory process and industry best practices to put the best plan in place for producing safe products.

Leachables Studies

Boston Analytical regularly performs leachables studies with all drug forms; including parenterals, inhalation products, topicals, opthalmics, combination products, biopharmaceuticals, and medical devices. Our team of experts can help you identify and address potential risks to ensure effective closure systems, process equipment and packaging.

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.

Risk Assessment

The Boston Analytical risk assessment process involves evaluating the leachables risk for the packaging, processing component, or medical device. 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.