Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

By Brian Svaton

The medical and pharmacological industries use parenteral preparations to help millions of people annually get well or live better lives. Parenteral preparations can be solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion as well as gels for injection.

Whatever form the preparations take, they are sterile preparations. Because they are intended to be administrated directly into patients’ bloodstreams, such preparations must be vigilantly protected to potentially safeguard patients’ lives.

Cue the humble intravenous (IV) bag, used every day to deliver parenteral solutions to patients for many reasons from hydration to cancer treatment.

In the event of an IV bag leak, contaminants including microorganisms, reactive gases, and other substances could potentially cross a container closure barrier adversely affecting the solutions within. Learn how the reference standard for container closure integrity testing, USP 1207, applies to the CCIT inspection method of IV bags.