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
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 … Read more
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 … Read more
Trisha Gladd, Editor for Life Science Connect, wrote an article for Pharmaceutical Online. Which talked about the rise of FDA recalls due to the presence of particulate matter in injectables. Trisha interviewed vice president of quality assurance at West Pharmaceutical Services, Bob Nase, who stated that the process of creating and filling the injectable drugs … Read more