Container Closure Integrity Testing Of IV Bags

By Roz Wyatt, ATC, Inc.

As a means to ensuring the safety of sterile products, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have provided strict guidelines for the testing of container closure systems. Manufacturers of IV bags are one of the many industries that must meet these test requirements. IV bags may be filled with water, saline, sugar solution or various drugs. Testing these bags for leaks is of the utmost importance since leaks may compromise the sterility of the overall container and hence user safety.