Helium Leak Testing is described as a means of finding leaks in different types of enclosed or sealed systems utilizing helium as a “tracer” gas. These sealed systems can be a wide variety of package types and sizes – Vials, syringes, cartridges, foil blister cards, bottles, tubes, foil pouches/sachets – for the most part any package format where the helium gas can be introduced before or during the leak test cycle. Helium leak detection methods utilize a highly sensitive mass spectrometer detector to accurately evaluate each sealed package/system type. A vial, consisting of a container (glass or plastic) and elastomeric closure, is a good example of a package system. A vial can be helium-filled & and then subjected to vacuum pressure. Any amount of helium escaping from that vial container is quantitatively measured and stated as a leak rate (flow rate) expressed in mbar L/sec. Each of these package types is designed and intended to keep the drug product from any detrimental environmental contaminants, such as oxygen, water vapor, and microorganisms, thus assuring product efficacy and microbial sterility for the intended shelf-life.
Helium gas key attributes that make it ideal for package leak testing:
- Quantitative helium leak rate data not only provides pass/fail package seal quality and container closure integrity but allows for direct comparison across various packaging materials/forms, production line settings, and stability storage conditions.
- Helium gas is one of the smallest atoms, allowing it to breach leak pathways reliably, easily, and quickly. Helium is a non-flammable, inert, odorless gas making it ideal for leak detection.
- Most leak test cycles are less than 1 minute – 100% helium flow methods can be as short as 30 seconds.
- Low levels of ambient helium (5 – 20ppm) ensure high signal to noise ratios thus highly accurate leak rate data.
Benefits of Using Helium Based Testing Methods:
Helium is a highly sensitive leak test technology, specifically designed for the detection of extremely small leaks and tortuous pathways which is not possible with any other leak testing methods.
Using a high vacuum technique, the leak test thresholds can be set down as low as 1×10-10 mbar L/sec, a sensitivity level allowing unique comparisons between package components, materials selection, and production controls, for example.
The world’s regulatory agencies have placed more focus on container closure integrity issues during the past 20 years. More emphasis has been laid on improved technology that enables the use of more effective test methods in place of typical sterility testing. The objective is to ensure that contaminants cannot penetrate the intended barrier that a closed system is designed to maintain. Examples of such contaminants include gases (especially reactive ones), any type of microorganism or any other foreign substance that can compromise or react with the enclosed drug product or compromise the sterility of the system.
The Packaging Technologies & Inspection (PTI) team brings a level of experience and knowledge to the Container Closure Integrity testing (CCIT) market that is unmatched. We are committed to assisting and ensuring that you understand and meet the strict regulatory requirements when it comes to your container and package system testing needs.
Seal Integrity Monitoring System
Our current model, the SIMS 1915+, is the ideal choice for your helium-based leak detection requirements. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures the highest levels of sensitivity. Such an approach allows a comparison between multiple packaging materials and forms, production line and manufacturing control, and stability storage conditions, supporting the entire lifecycle.
The PTI SIMS 1915+ has an array of applications which range from package design, R & D, tooling qualification, production line setup and on-going product/package quality monitoring. It is also effective in accommodating a variety of package types including cold form blister cards, foil pouches, parenteral vials, syringes, cartridges, bottles, tubes, and unique medical devices. Although the base SIMS 1915+ model can accommodate a range of package formats, there are customizable features that allow leak testing to a client’s specific requirements. Instrument build specifications are determined based on the following key factors:
Identifying what type of package formats you would like to test with this instrument – Vials, Blister Cards, Syringes, Cartridges, Tubes, etc. The determination of various package sizes and formats allows for the most cost-effective initial system set-up and provides the potential for low-cost add-on features when other test types may be needed. Knowing if some leak testing requirements will be at low temperature conditions. The PTI SIMS 1915+ has a variety of cold temp/ultra cold temp add-on devices to fit these specific needs.
Specifically designed to meet the leak testing needs of pharmaceutical, life sciences, and biotechnology industries, the Seal Integrity Monitoring System (SIMS) Model 1915+ is comprised of a Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface and Dual Test Port Manifold. It enables quantitative analysis of package systems at sensitivity levels as low as 1×10-10 mbar L/sec at room temperature and cold test temperature environments. The console is castor mounted and includes an articulating arm system for mounting the computer and peripherals, making the freestanding unit easy to use and maneuver.
Another key feature included with the SIMS 1915+ unit is the addition of ETHOS – HLD – our software platform that controls the HLDM, collects and tabulates the data, and provides reports & test summaries all under 21CFR Part 11 compliancy.
In addition to instrumentation and accessories, we also offer complete sets of External Calibrated Helium Leak standards to support routine use: daily performance verification/validation, system suitability checks, and scheduled qualification testing. Included within each SIMS 1915+ is an internal helium leak standard which is used to automatically calibrate the instrument on each day of use, or on demand for a point-of use autocalibration prior to analysis.
