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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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…
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Avoiding Glass Delamination
Cleanroon Technology published an article in 2011 titled Avoiding Glass Delamination. Delamination is where a material fractures into layers; it is a mode of failure and is unsafe in many scenarios. Delamination of a glass container carrying parenteral drugs has resulted in many drug recalls. This leads to particles in the drug itself; such as…
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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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