Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Companies choose manufacturing processes -- such as job order, batch process, assembly line and continuous process -- based in part on the level of product individualization allowed. Manufacturers use ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...

As of late November 2024, the US Food & Drug Administration had recorded 46 voluntary drug recalls in the United States during the year, down slightly from previous years – an indication that ...

Batch process manufacturers are continuously looking for new ways to improve processes and production techniques and to be more efficient to remain competitive. Although manufacturers see new ...

Batch processing, or batch production, is a scaled-down version of assembly line production. Products are produced in groups instead of in continuous streams as they are on assembly lines. However, ...