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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Getting Particular About Particulates
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…
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The Future Of Wearable Injectors
Around the world people are believing that wearable injectors are expensive and complex. Jesper Roested, Chief Executive Officer of Subcuject, explains how those beliefs could be false. Jesper Roested expressed that this technology is part of the modern-day pharma industry; the at-home industry is rapidly growing. The pharmaceutical industry is shifting towards patient-centric and putting…
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The Importance of Data Integrity
On January 15, 2021, GMP Trends posted Issue #1056. In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years. For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked…
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