Appropriating Biophorum Operations Group (BPOG) testing on single-use connectors to mitigate the risks of extractables and leachables (E&L), as demonstrated in this article, is crucial to delivering safe and effective drugs.
Biomanufacturers submitting a biological license application must include E&L data to demonstrate overall product quality. This white paper outlines how the AseptiQuik connectors have been tested to ensure that the levels of extractables that come from the connector is quiet low.
What is covered:
- Extractables and leachables (E & L) defined
- Risks of E&L
- Defines the testing conditions of AseptiQuik connectors
- Initial data findings and learnings from the tests
- How working with trusted suppliers that are committed to risk mitigation and compliance will make your application process much easier