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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Improving Visual Inspection Practices
Improving Visual Inspection Practices, written by Jennifer Markarian with Pharmaceutical Technology, she interviews John Shabushnig, PhD and talks about the need of improving the understanding and practice of visual inspection of parenteral drugs. Their interview gives guidance of where to search for help, as well as what is recommended. PDA and USP have been working together…
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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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