In the high-stakes world of pharmaceuticals and medical devices, ensuring the integrity of packages isn't a mere formality; it's a fundamental pillar of safety and efficacy. For decades, meticulous package integrity testing methods have served as the gatekeepers, diligently sniffing out potential breaches that could compromise lives and livelihoods. Yet, traditional approaches often fell short – lacking the sensitivity to detect microscopic flaws, the versatility to handle diverse package formats, and the quantitative data to provide actionable insights. In order to overcome the shortcomings of traditional methods, manufacturers now rely on non-destructive, deterministic package testing alternatives.
Helium Leak Detection - An Overview
Helium leak testing refers to the process of 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. It is an effective container closure integrity test method, aimed at evaluating the integrity of pharmaceutical and parenteral products. The process involves filling the package with helium and subjecting it to vacuum. A helium leak detector is then utilized to quantitatively measure the amount of helium escaping from the package, which is expressed as a leak rate. Beyond evaluating container closure integrity, helium leak testing finds applications in product design, quality analysis, failure analysis, and validation. It offers flexibility as it can be conducted with or without a test chamber, enabling testing for "in-leakage" or "out-leakage," as well as locating leaks.
Helium is considered an ideal choice of tracer gas because of multiple reasons. Helium 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 relatively safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes.
Helium Leak Testing Using SIMS 1915
The Seal Integrity Monitoring System (SIMS) 1915+ stands out as the ideal solution for helium-based leak detection across a range of pharmaceutical and medical device packaging systems, including vials, syringes, cartridges, and blister cards. It's particularly effective for parenteral products, such as ensuring the integrity of rubber stoppers on vials or plungers on syringe assemblies.
Utilizing helium as the tracer gas, this system allows for quantitative testing that surpasses traditional methods like vacuum bubble and dye penetration tests by a significant margin. This quantitative approach facilitates direct comparisons among different packaging materials, formats, production line settings, and storage conditions, supporting the entire product lifecycle. The SIMS 1915+ offers the capability for quantitative analysis with a sensitivity level as low as 1 x 10-10 mbar/L/sec. It provides comprehensive data sets instead of simplistic pass/fail criteria and can conduct testing at room temperature.
Each SIMS 1915+ Helium Leak Testing instrument is meticulously crafted to meet client-specific standards and package configurations. We specialize in engineering custom test fixtures tailored to the components being tested, ensuring precision and accuracy to fulfill your study objectives, accommodate various package configurations, and meet quality monitoring requirements.
SIMS 1915+ Options:
- LT 80 and LT 150 Cryo-Chiller Low Temperature Add-on Modules for ultra-cold Container Closure Integrity 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.