This chapter is taken from the book Contamination Control in Healthcare Product Manufacturing, Volume 2

This chapter describes some of the sources of particulate matter contamination in injectable drugs and the clinical effects that can result from such contamination. It also reviews the development of standards and regulations to control contamination of injectable products and offers some preliminary next steps for manufacturers, regulators, and standards-setting organizations who are working together to ensure patient safety.

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About the Author

Stephen Langille is a Senior Microbiology Reviewer in the Center for Drug Evaluation and Research's Office of Pharmaceutical Quality — New Drug Microbiology Staff. He received his Bachelor of Science Degree in Biology from the University of Massachusetts and his Doctor of Philosophy degree in Microbiology from the University of Maryland. He is one of the New Drug Microbiology Staff's representatives to the Pharmaceutical Inspectorate Program and a member of the FDA Standards Working Group. He also served as an FDA liaison to the USP Parenteral Products — Industrial Expert Committee and currently serves as FDA liaison to the USP Dosage Forms Expert Committee.