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Related Topics >> 21 CFR Part 11 | traceability

Cambrex automates plant processes

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An upgrade from manual monitoring and recording practices to automated systems has earned Cambrex Profarmaco a 4 percent increase in overall equipment effectiveness.

The Milan, Italy-based drugmaker, a producer of 70 active ingredients used in generic drugs, has implemented Emerson Process Management's PlantWeb digital plant architecture. The growing company's goal was to speed process validation and simplify batch traceability while maintaining regulatory compliance. It needed precise control of process variables and automated record-keeping.

The PlantWeb architecture includes the Delta V automated system for precision process control and predictive maintenance. PlantWeb's AMS software uses predictive intelligence to optimize equipment availability and performance.

Temperature and pressure instruments, analytical pH and conductivity meters, and mass flowmeters also are part of the package. The system maintains Cambrex's 21 CFR Part 11 compliance. And it improves the company's data traceability and process reproducibility while capturing data for GMP documentation.

- see the announcement

Related Article:
Regulator's plans require automation


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