Blogs

Leak testing may be understood as a form of non-destructive quality control procedure used to determine if an object, product, or system functions within a specified leak limit. When a gas or liquid escapes through a manufacturing defect such as a hole, crack or weak seal, it is considered a leak. Since such a leak can compromise quality of the product, appropriate leak testing is an important quality control criteria for manufacturers.

Overview of helium leak testing?

Helium leak testing is considered as one of the most sensitive Container Closure Integrity test methods. In simple terms, it can be understood as the process of using helium mass spectrometry for finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. This technique is widely used for evaluating integrity of critical parenteral or injectable products. Helium is used as a tracer gas because it is non-toxic, non- flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes.

Helium leak detection using SIMS 1915+

LDA's Seal Integrity Monitoring System (SIMS) 1915+ is a helium-based leak detection technique proven to be effective for a variety of pharmaceutical and medical device product package systems. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This technique is applicable across a wide range of pharmaceutical and parenteral products including vials, syringes, cartridges and blister cards.

SIMS 1915+ enable quantitative analysis of packages at a sensitivity level as low as 1 x 10-10 mbar/L/sec. and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at ambient temperature as well as cryo storage conditions. Each SIMS 1915+ Helium Leak Testing instrument is custom built to client specific standards and package configurations. We specialize in the engineering and development of custom test fixtures tailored to the component to be tested, which ensures precision and accuracy to meet your study goals, package configurations and quality monitoring needs.

SIMS 1915+ Options:

• LT 80 and LT 150 Low Temperature Add-on Systems for ultra-cold CCI testing using helium leak methodology.
• Various sizes of Vacuum Test Fixtures to accommodate all package types and sizes.
• Custom Test Fixtures to allow Helium leak testing for non-vacuum chamber applications.
• Additional External Helium Leak standards in various leak rate ranges.
• Helium Sniffer probe – for site specific determination of leak sites.