Case Studies

Container Closure Integrity Testing of Intravenous Bag

Container Closure Integrity is a parameter that tells weather the container is capable of maintaining a sterile barrier throughout its life-time. Intravenous (IV) bags are used to deliver medicinal fluids quickly in the body. Parenteral packages become very risky if they leak as the fluids, they intend to deliver directly in the blood stream of the unwell may result in microbial growth. Hence, sensitive and reliable CCI testing becomes a necessity.

VERIPAC VACUUM DECAY TECHNOLOGY

The technology involved in the sensitive CCI testing of the IV bags is 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. This technology gives fast, repeatable and reliable test results that provide quantitative and quality assurance.

VeriPac inspection method not only uses vacuum decay technology but also is able to evaluate the integrity of the packaging non-destructively. PTI’s VeriPac vacuum decay technology uses a differential pressure transducer leak test system to detect package leaks and invisible defects. The method is non-invasive, non-subjective and requires no sample preparation.

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