Single-Use Technology Risks in Biopharmaceutical Manufacturing
Single-Use Technology (SUT) is transforming biopharmaceutical manufacturing with improved flexibility and reduced cleaning requirements. However, it introduces risks such as extractables and leachables, chemical migration, sterility breaches, and supply chain dependency. Effective risk management through material compatibility checks, integrity testing, and regulatory compliance is essential to ensure product safety, maintain quality standards, and support reliable manufacturing operations.