Container Closure Integrity Testing of IV Bags

The Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) issue strict guidelines for testing the integrity of container closure systems. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements. IV bags, being high-risk sterile packages, are required to be tested for integrity during their product life cycle, lack of which could compromise container sterility as well as patient safety.

Container Closure Integrity Testing of Intravenous Bags

Container Closure Integrity (CCI) is defined as whether the container is maintaining a sterile barrier. Intravenous (IV) bags play a significant role in the rapid delivery of fluids and medications. Leaking parenteral products are considered extremely high risk, as they deliver fluid directly into the bloodstream and have a high potential of microbial growth requiring the need for sensitive and reliable CCI testing. IV bags can be effectively tested using VeriPac Vacuum Decay technology. PTI’s VeriPac Vacuum Decay technology is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system. The method is non-invasive, non-subjective and requires no sample preparation. The VeriPac 455 leak detection system is connected to a test chamber containing the IV bag. The test is conducted by drawing vacuum on the IV bag in the test chamber and monitoring for any changes in vacuum level. In case of a defective package, air or fluid will leak from the package into the chamber causing a change in pressure. Non-leaking packages do not leak any pressure into the chamber holding the chamber vacuum level constant. The VeriPac system provides quantitative test data to ensure leak detection and reduce false positives. Regardless of defect location, the vacuum decay system can pick up both large and small defects. Case studies have proven that each defect type was tested multiple times to determine defect detection capability. While specific tooling for the application is required, testing can be performed with ease. The cycle time for the IV bag testing is under 40 seconds and is sensitive and repeatable to 15 microns for both liquid and gas leaks. Depending on fill volume and package size, smaller defects can be detected.