Material selection and qualification support for polymer-based manufacturing systems
Single-use systems are widely used in pharmaceutical and biopharmaceutical manufacturing, but polymeric materials introduce extractables and leachables (E&L) risk that must be evaluated carefully. Selecting the right components—and qualifying them for use—requires extractable and leachable analysis aligned with established industry guidance rather than prescriptive regulatory checklists.
BA Sciences supports extractables and leachables testing for single-use systems, helping manufacturers evaluate materials, qualify components, and assess process risk in accordance with BPOG and USP guidance.
Single-Use System E&L Testing Services
BA Sciences performs extractables and leachables testing to support both material selection and material qualification for single-use system components used in pharmaceutical and biopharmaceutical manufacturing.
BPOG Extractables & Leachables Testing
The BPOG guidelines for extractables and leachables provide a standardized framework for comparative evaluation of single-use system materials. Testing under this protocol generates consistent extractables data sets, allowing end users to compare components across vendors.
Our laboratory applies the BPOG protocol to support informed material selection and vendor qualification decisions.
USP <665> and <1665> Material Qualification
USP <665> and <1665> address the characterization and qualification of plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing. Material qualification testing under these chapters demonstrates suitability for use within defined manufacturing processes.
We apply USP <665> and <1665>–aligned testing at the component level and, when appropriate, across the full manufacturing process to confirm that leachables are not migrating into the product during use.
Single-Use System Component Coverage
Our experience includes extractables and leachables testing across a wide range of single-use system components, including bags, tubing, connectors, filters, filtration cassettes, sensors, valves, gaskets, O-rings, mixer components, and filling needles.
This component coverage supports consistent evaluation of individual materials as well as assembled systems using a unified testing approach.
