Maintaining process closure is crucial for ensuring product quality and safety in biotechnology manufacturing, especially when using single-use systems (SUS). This approach is an integral part of the contamination control strategy (CCS). To validate process closure in SUS-based biotech manufacturing, a comprehensive method is necessary, incorporating: By employing risk analysis tools such as Hazard Analysis … Continue reading Validating Manufacturing Process Closure for Biotech Utilizing Single-Use Systems (SUS)