High Sensitivity Leak Detection Methods for Medical Packaging

Medical components and products require high sensitivity FlexPak package leak detection equipment as well as precise specifications. Testing for leaks in pharmaceutical and medical packaging ensures protection from bacteria, moisture, and air.
Main areas of testing include bio process containers for serum and other biologicals; blister packs; liquid filled & lyophilized vials; and liquid-filled syringes. Tracer gas and air test methods are the leak tests frequently used for these types of medical products and packages.Frequently Used Leak Detection Methods

Several leak detection methods can be employed towards ensuring medical equipment and products safety. For manufacturers of packages, it is important to fully appreciate the properties of each method so as to choose the right one or a combination of several.

Helium Hard Vacuum

This is an automated method in which the test fixture or part is evacuated to a complete vacuum while to the opposite barrier part, helium is introduced. Leaks using this method can be measured outside-in or inside-out. This technique can detect leaks down to 1 x 10-9 atm cc/sec.

Air Leak Testing

This method employs a variety of automated tests that utilize air as the channel for detecting leaks. This includes mass flow and pressure decay using air. The air leak test can detect product packaging leaks, depending on part construction, size and cycle time, down to as little as 0.01 atmcc/sec.

For High Sensitivity Product Packaging

Often, medical devices involve barriers between gases or fluids. These barriers have to function effectively in order to give protection to the patient and, at times to also protect the medical device or equipment itself.

Some of the medical devices act as pathways for extracting or delivering fluids from and to a precise body location. In the event of a leak along the pathway, there is a possibility of the fluids being extracted or delivered to the wrong body location, often with dangerous consequences.

The most common leak detection methods include tracer gas and pressurized air systems. There is now, however, more focus on the use of hydrogen as a main tracer gas for product packaging leak detection.

For medical implants like artificial hearts, pacemakers as well as other devices critical to promoting human life and health, the product packaging leak testing method preferred by manufacturers of packages is the helium vacuum route due to its high levels of sensitivity.


To those engaged in medical product packaging, testing is indispensable to the manufacturing process. In particular, this is vital as medical equipment standards for product manufactures are becoming increasingly stringent. For manufacturers of packages, choosing the most appropriated leak detection equipment method is often a complicated challenge, yet a very important step.

Manufacturers of medical products and equipment should explore with great care the various leak-testing methods available in the market. These are providing opportunities for improving quality assurance, minimizing product failures, and lowering testing costs. For more information visit the FlexPak website.

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