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…
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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…
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Particulates in Parenteral Products and the Search for the Holy Grail
Particulates in parenteral products as well as other pharmaceuticals have gained increased attention from regulatory agencies and from pharmaceutical firms who desire to be in the forefront of patient safety and effectiveness in the products they supply for patients. Foreign particulates in parenteral products come from multiple sources and can vary widely in type, size…
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Controlling for Particulate Matter in Injectable Drug Products
Ever since the development of the earliest intravenous therapies, the presence of particulate matter in injectable drug products has been a concern among clinicians. In recent years, there has been an increase in the number of drug product recalls due to the presence of particulate matter. These recalls are actions taken by a company to remove…
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