Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
Testing for leachables (substances that migrate under normal conditions) and extractables (those that migrate when exposed to solvent under harsh conditions) is critical for the pharmaceutical industry. Although formal guidelines for E&L assessments have not yet been enacted for Single Use Systems, there is a regulatory expectation that tests will be performed. The FDA’s Center for Biologics Evaluation and Research recommends a risk-based approach to evaluation.