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The growth in complex biologics is boosting the demand for innovative delivery mechanisms such as prefilled drug-delivery systems. Unfortunately, these systems often encounter issues with particulates that can lower a drug’s effectiveness or trigger unwanted side effects. In response, regulatory authorities are demanding processes be developed that either eliminate or keep at a minimum, visible and sub-visible particles and other contaminants.
The reasons why particles occur are diverse. So are the types and sizes of particulates. Visible particles (about 100 – 150 µm and larger) can be spotted with the unaided eye during visual inspection…