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 come from the person creating the drug product.  An increase in the number of recalls due to particulate matter in parenterals has attracted attention to the industry, making it necessary to improve the quality of the products they were supplying.

In 2013, it was estimated that approximately 190 million liters of intravenous fluids in the United States are administered to patients each year. Particulate matter contamination has had several different clinical effects; all ranging from minor problems to serious complications—such as death.

This was all dependent on size, shape, how many particles, and what the particle was made of. Any and all complications were very important for drug manufactures to take control of. Manufactures have taken many actions, trying to address the issue.  This including implementing a defined process of monitoring drugs before being approved for distribution.

One challenge that is brought up with using this testing technique, was the increase of time and money.  However, in the long run, this testing could save manufacturers a lot of money with having less recalls and safer products. InQuest Science’s Identifier System, will help all manufactures have a uniformed inspection process; following all USP <790> inspection test qualifications.

Learn more about PharmTech particulate matter challenges and their QbD approach to minimizing issues. Read the full article written by published by Pharmaceutical Technology (Volume 38, Issue 11)

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