Manufacturing Systems, Single-Use

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The EZ-Fit Filtration Unit, a ready-to-use, disposable filtration device for bioburden testing from EMD Millipore, the Life Science division of Merck KGaA, increases reliability and streamlines workflows.

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Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.