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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New Guidance for Visual Inspection
Article Written By: Roy Cherris, Bridge Associates International | May 30, 2017 As an industry, we have been performing 100% visual inspection for visible particles in parenterals for more than 70 years. Yet, during much of this time, there has been a lack of clear guidance, or harmonized scientific approach, for particulate and physical defects.…
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