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How to Leak Test Medical Fluid Bags

Time to Read: 2m 49s

By Jeff Jackson, VP Operations (jjackson@zaxisinc.com)

Leak testing medical fluid bags—including IV bags, blood bags, feed systems, ostomy bags, airway products, and more—is a critical step in producing these essential items. Fluid bags are made of flexible material and feature ports, tubes, and other components exiting the interior of the bag. As leaks can have extreme consequences for healthcare providers and patients, comprehensive leak testing must be completed before these bags go to market.

Leak Testing Medical Fluid Bags

Medical fluid bags are typically made through high-volume productions using ultrasonic welding, adhesive or solvent bonding, and other methods. Leak testing during manufacturing ensures that all joints, welds, and surfaces are free of flaws, defects, pinholes, or perforations. Leak testing also will check that your required flow can be achieved.

Pressure decay testing is the most common and effective leak testing method for medical fluid bags. Using pressurized air, pressure decay testing identifies leaks by measuring any decreases in pressure over time to produce reliable, accurate results. Follow these steps to complete testing using automated leak testers.

1. Load Bags

Medical fluid bags are made of pliant materials, and they must be restrained during testing. Place the medical fluid bag into a restraining device, such as a plate fixture, to minimize the volume of the pressurized bag, limit elastic creep, and prevent stretching from occurring during leak testing. When the bag is secured, insert the leak tester connector into each open port.

2. Run Pressure Decay Testing

Pressure decay testing begins. An automated leak tester fills the medical fluid bag with air until pressurized. The air source is valved off, and the pressure settles. The test’s sensitivity will vary depending on several factors, including the product’s size and the test’s time interval. A longer cycle time is necessary for larger fluid bags to ensure quality and accurate outputs. Smaller fluid bags will require significantly less time, allowing you to increase throughput.

3. Detect Gross and Fine Leaks

Leaks are present if the air pressure decreases over a pre-determined timespan. If pressure decreases, your medical fluid bag has failed the leak test. Further design considerations, troubleshooting, or other steps will be necessary to address the issue.

4. Vent Pressure

When testing is complete, the pressure is vented to atmosphere, returning the medical fluid bag to its original state.

Ensure Medical Fluid Bag Quality with Innovative Leak Testing Equipment

The best way to achieve repeatable and precise results is to integrate high-quality leak test equipment into your production line. The Zaxis family of products is the top choice for medical manufacturers. Our cutting-edge leak testers are engineered and manufactured in the USA, and they are ready to tackle the rigors of leak testing medical fluid bags. We offer:

Our leak testing equipment runs pressure decay tests that are accurate up to the 5th decimal place or 0.00001 PSI, allowing for fast test cycles. Compact designs and modular constructions make full line integration a straightforward process. You can depend on our leak testing solutions to perform without issue or malfunction, helping you to improve output for your customers.

Contact Zaxis for Assistance on How to Leak Test Medical Fluid Bags

Contact us today to learn more about how our top-of-the-line products can improve your medical fluid bag production. Request a quote to begin your order.

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