Pharmaceutical Container Closure Integrity Testing For IV Bags
The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.
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.
Leak testing IV bags can be challenging for several reasons:
- Small leaks: IV bags are often made of thin plastic materials, and even small punctures or tears can cause leaks. These small leaks can be difficult to detect simply by manual or machine vision.
- Complex design: IV bags have a complex design with multiple layers of materials, seams, welds and ports that can make accurate, sensitive leak detection of the entire IV bag challenging.