IV Bags

Container Closure Integrity Testing of 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.

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IV-BAG-CCI-Solutions-Brochure
CCI Testing of Intravenous Bags Case Study
PTI Whitepaper - Limit of Detection (LOD)

IMPORTANT FACTORS TO CONSIDER:

Leak Location

IV Bag and Polymer

Type
Thickness
Layers

Volume & Fill Level

Additional Challenges

Seems, Joints
Barbs and assemblies

Test Method Considerations

Air Flow vs. Liquid Flow
Validation Probable Leak Conditions and Locations

Container Closure Integrity Testing of Intravenous Bags

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 deterministic, non-subjective and requires no sample preparation. The VeriPac 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 result data to ensure leak detection and reduce false positives. Regardless of defect location, the vacuum decay system can detect both large and small defects. Case studies have proven that each defect type was tested multiple times to determine defect detection capability. The cycle time for the IV bag testing is fast, sensitive and repeatable for both liquid and gas leaks.

A range of IV bag test chamber configurations depending on IV bag dimensions, profile (thin vs. thick) and fill volume are available. Test sensitivity will depend on fill volume and package size. Both standard and customized solutions are available to achieve the optimal inspection solution for each IV bag application.

VeriPac Technology Benefits:

VeriPac solutions leak test the entire IV bag including weld and port regions that are subject to damage and stress
Test chambers are designed to accommodate various IV bag profiles, fill volume and thickness
Reliable, consistent and repeatable leak detection

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Container Closure Integrity Testing of Intravenous Bags

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