Abstract
The control of extraneous particles and prevention of their gaining access to injectable products or medical devices is a key issue in pharmaceutical manufacture. Particles occurring in the as-manufactured injectable material can arise from the container closure, the solution or powder itself, or from the environment. The ultimate control of particulate matter in pharmaceutical manufacture is not achieved through compendial limits, but through the manufacturer’s application of good manufacturing practice (GMP). GMP dictates the consistent execution of a thoroughly validated process, and the monitoring and control of particulate matter related to each process step and process component. This paper serves to (1) review particulate matter control in pharmaceutical manufacture; (2) discuss instrumental particle analysis; and 3) familiarize the reader with control and monitoring of extraneous particles in pharmaceutical manufacture.
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