Leak Testing

DDL uses three main package leak testing methods:

Package Leak Testing by Vacuum

One established means of testing the integrity of packages nondestructively involves applying pressure or vacuum to packages inside airtight chambers to reveal leaks.  The initial pressure applied to the package in the chamber is measured against a final pressure, and the change in pressure represents a measure of leakage. Vacuum testing can detect very small leaks.

For more information, click on the following ASTM standards:

ASTM D3079-02	Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
ASTM D4991-94	Leakage Testing of Empty Rigid Containers by Vacuum Method

Package Leak Testing by Dye Penetration

Dye penetration leak tests involve applying dye evenly onto a package to detect the dye seeping into any defects.  After a specified period of time, the dye on the surface of the package is cleaned and a white powder observant is applied to the surface, which performs a blotting action. The result of the test is determined on a pass/fail basis by subjective evaluation. Leak testing by dye penetration also involves conditions that destroy or taint the packages, so the packaged product may be destroyed. Manufacturers therefore must plan to waste a certain amount of packaging material and a number of products during testing. Watch a video on leak testing by dye penetration. For more information on leak testing by dye penetration, see ASTM Standard F1929

Leak Testing

Package Leak Testing by Bubble Emission

Leak testing by bubble emission is also a destructive testing method and just like with dye penetration, manufacturers should expect to waste a certain amount of package material and products. Leak testing by bubble emission involves submerging the package underwater and looking for leaks.  Watch a video on bubble leak testing. For more information on leak testing by bubble emission, see ASTM Standard D3078 and F2096

Product Leak Testing

A variety of medical devices need to be tested for leakage, including any that are expected to contain a fluid, keep a fluid out, or conduct fluids from one place to another. Product leak testing is commonly performed by blocking all but one opening into the device, and introducing air or a liquid at a pressure somewhat higher than is expected in vivo. The subject device is then inspected for evidence of leakage over a specified period of time. Vacuum is also used in some leak tests, to detect any ingress of fluid while the pressure inside the device is reduced.

Frequently used standards for medical device leak testing include:

ASTM D5151 for sterile gloves
ISO 594 for Luer fittings
ISO 595 for metal/glass syringes
ISO 7864 for needles
ISO 7886 for single-use syringes
ISO 8536 for infusion sets
ISO 10282 for sterile gloves

ISO 10555 for intravascular catheters
ISO 11070 for intravascular catheter introducers

For more information on any of DDL's testing services, contact us today or call 1-800-229-4235.