White Paper

Container Closure Integrity Testing Of Intravenous Bags

By Wen Chen Ph.D , and Oliver Stauffer, CEO

Container Closure Integrity (CCI) is defined as whether the container is maintaining a sterile barrier. Intravenous (IV) bags are crucial in delivering fluids or medication quickly. Leaking parenteral packages are considered an extremely high risk as they deliver fluid directly into the bloodstream and have a high potential for microbial growth, requiring the need for sensitive and reliable CCI testing.

VERIPAC VACUUM DECAY TECHNOLOGY

Vacuum Decay technology is one of ASTM Standards “Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method” (F2338-09). This technology is also a physical test method that is recommended by UPS 1207 and is an FDA consensus standard that can be used for CCI testing for high risk package applications with fast, repeatable and reliable test results that provide quantitative and deterministic quality assurance. This technology can be used on a wide variety of package formats, product classes and product combinations.

Packaging can be non-destructively evaluated using the VeriPac inspection method which is based on 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.

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