Umetrics Suite Blog

Interpretation for the use of multivariate models within the FDA draft guidelines for continuous manufacturing

April 24, 2019

Recently the FDA issued a new draft guideline for continuous manufacturing of small molecule drugs. With these draft guidelines the FDA wants to engage more pharmaceutical manufacturers to shift from traditional batch/start-stop processing to continuous manufacturing. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, but also more consistent quality of the drug product. Of course the main incentive for the FDA to promote this way of processing is that it believes that this will have a positive impact on drug prices and prevent drug shortages.

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Real-time release enables early fault detection in injection molding manufacturing

April 11, 2019

Injection molding is the most important production method for manufacturing plastic components used in products ranging from cars to medical devices. Although the plastic components themselves are often inexpensive to produce, any defect can lead to expensive errors that can affect the performance or safety of the finished product. Creating a system of early fault detection and continuous process improvement can mean big payoffs for manufacturers.

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Using advanced data analytics to make the shift to continuous process manufacturing

April 2, 2019

Throughout the evolution of manufacturing, many industries have gradually shifted away from batch process to continuous process manufacturing as production technologies matured. This has included industries such as chemical, petroleum, steel, automobile, consumer goods and food manufacturing.

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