Validation steps: Qualifying your new comminuting mill
How can you be sure your new process equipment will operate as specified? You need to validate it with a series of qualification tests. This article demystifies the validation process by explaining how a new comminuting mill was validated at a pharmaceutical plant. You can adapt the step-by-step process outlined here to validate other size reduction or process equipment in your plant.
In processing plants for pharmaceuticals, chemicals, biotech materials, and other dry bulk materials, new equipment must be validated -- that is, tested -- to ensure it meets several acceptance criteria. These can include FDA regulations, current good manufacturing practices [cGMPs] for pharmaceuticals, good laboratory practices, good clinical practices, and industry standard ISO 9000.