particle control

Particulate Identification

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In USP <1790> it focuses on detecting and removing units of visible particles; in addition, it promotes the need of preventing particulate contamination—which only comes from identifying the particle.  Most pharmaceuticals require an understanding of particulate matter contamination.  The ability to identify and characterize a particle is extremely beneficial with improving products within the development … Read more

Essentially Free:  How A Definition Tamed The Visible Particulate Matter Debate

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In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter.  In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present. In 2014, recalls in injectable … Read more