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
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
Visible Particulate Matter in Single-Use Bags
In an article published by BioProcess International, visible particulate matter in single-use systems (SUS) is stated to be a big concern. SUS is a product/equipment designed to be used once; it is primarily composed of plastic that can be discarded easily. It is necessary when creating products with SUS, the parenteral drugs must be “essentially…
Read more
Parenterals, Particulates, and Quality by Design
Particulate matter in parenteral drugs has been a known issue for over two centuries. Particular matter could come from any little thing that is involved in the process of making the drug product. Contaminants could come from the environment, packaging for the product, ingredients in the product, reactions of the formula and anything that could…
Read more