Powder Filling: When and Where to Monitor

Abstract

Powder filling is the process predominately associated with active pharmaceutical ingredients (API) where bulk powdered materials are filled into vessels prior to shipping to secondary processors. The very act of powder filling in a Restricted Access Barrier System (RABS) enclosure will create a dust cloud so dense that a particle counter operating in that area will become saturated and the data of no use. In addition, a lengthy purge cycle will be required before the particle counter can be used again to monitor for contaminants. Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.

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