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Vials are widely used to package biologics, vaccines, and injectable drugs. To keep these products safe and effective, the vial and its closure system must remain properly sealed throughout storage and distribution.

Even very small leaks can allow moisture, oxygen, or contaminants to enter the package, potentially affecting product quality and sterility. Because these defects are often too small to be seen, pharmaceutical manufacturers need sensitive testing methods to detect them.

The SIMS 1915+ is a helium leak detection technology designed to identify extremely small leaks in vial packaging. With sensitivity down to 1×10?¹° mbar·L/sec, it helps manufacturers evaluate container closure integrity and better understand package performance.

Why is Vial Leak Detection Important?

Pharmaceutical vials are designed to maintain a sterile barrier throughout a product's lifecycle. However, even microscopic defects can create pathways for moisture, oxygen, or contaminants to enter the package.

These defects may not be visible during routine inspections, yet they can impact product quality, stability, and shelf life. Detecting and measuring these leaks is essential for ensuring that the container closure system performs as intended.

Why is Helium Used for Leak Detection?

Helium is commonly used as a tracer gas because its molecules are extremely small and can pass through very small leak paths. It is also inert, meaning it does not react with pharmaceutical products or packaging materials.

These properties make helium an effective gas for detecting very small leaks that may be difficult to identify using conventional testing methods.

Where do Leaks Occur in Pharmaceutical Vials?

A vial closure system consists of the glass vial, elastomer stopper, and aluminum crimp seal. Leaks can occur at the stopper-to-vial interface, within the crimp seal area, or through small defects created during manufacturing or handling.

While these leak paths may be microscopic, they can still affect package integrity over time.

How does the SIMS 1915+ Detect Leaks in Vials?

The SIMS 1915+ uses helium tracer gas to evaluate vial integrity. During testing, the vial is exposed to helium and placed inside a test chamber connected to a sensitive detection system.

If a leak is present, helium passes through the defect and is detected by the instrument. The system measures the amount of helium escaping from the vial and converts it into a leak rate value.

This direct measurement approach allows manufacturers to identify active leaks and accurately assess package performance.

How does the SIMS 1915+ Achieve Sensitivity Down to 1×10?¹° mbar·L/sec?

The SIMS 1915+ uses helium tracer gas and a highly sensitive detection system to identify very small leaks in vial packaging.

Because helium molecules are extremely small, they can pass through tiny defects that may be difficult to detect using other package integrity testing methods. The system measures the amount of helium escaping through a leak, allowing manufacturers to obtain an actual leak rate value.

Rather than estimating package performance from pressure changes or other indirect measurements, the SIMS 1915+ directly measures leakage as it occurs. This provides clear and reliable data on container closure integrity.

With sensitivity down to 1×10?¹° mbar·L/sec, the technology can detect extremely small leak paths that could impact product sterility, stability, and shelf life over time.

Conclusion

Maintaining vial integrity is essential for protecting the safety, quality, and stability of pharmaceutical products. The SIMS 1915+ offers an extremely sensitive detection solution to even the smallest leak that could affect product performance over time. The system provides data that is accurate and reliable through the use of helium tracer gas and direct leak rate measurement, which aids package development, validation and quality assurance efforts. With changing packaging demands, SIMS 1915+ enables packaging manufacturers to gain a deeper understanding of the integrity of container closure and to make informed packaging choices throughout the product lifecycle.

Protecting high-value biologic products begins with ensuring the integrity of their packaging. These products are highly sensitive to environmental exposure, and even the smallest defect in a container closure system can compromise sterility, stability, and overall product performance. As a result, manufacturers require testing methods that provide accurate, reliable, and measurable insight into container closure integrity.

Helium leak detection has emerged as a highly precise deterministic method for evaluating package integrity, as it directly measures the flow of gas through potential leak paths. The SIMS 1915+ is an advanced helium leak detection technology designed specifically to support these requirements. By combining high sensitivity with quantitative measurement capabilities, it provides a dependable solution for assessing the integrity of biologic packaging under real-world conditions.

The Need for Advanced Integrity Testing in Biologics

Biologic products often require strict environmental controls, including cold and ultra cold storage conditions. Under such conditions, packaging materials, especially elastomeric closures, can undergo physical changes that may introduce micro leaks not detectable at room temperature.

Even the smallest leak can lead to:

• Microbial ingress
• Loss of sterility
• Product degradation
• Reduced therapeutic efficacy

Traditional methods like dye ingress and bubble testing cannot reliably detect very small, sub-micron defects. This has led to increased use of more accurate methods such as helium leak detection.

How SIMS 1915+ Works?

The SIMS 1915+ utilizes helium as a tracer gas to detect leaks in sealed packaging systems. Helium is introduced into or around the test package, and any escaping gas is measured using a highly sensitive detector. The measured signal directly correlates to the leak rate, providing a precise and quantitative result.

Helium is particularly effective due to its unique properties:

• Extremely small atomic size, enabling detection of very fine leaks.
• Inert and non-reactive, ensuring compatibility with sensitive biologics
• Low natural atmospheric presence, minimizing background noise for accurate readings

Reliable Performance at Low and Ultra Low Temperatures

Many biologic products are stored and transported under refrigerated or ultra-low temperature conditions. Such environments can influence the behavior of packaging materials, seals, and closure interfaces, which may in turn affect leak characteristics.

The SIMS 1915+ technology supports leak testing under these conditions, allowing evaluation to be carried out at temperatures that reflect actual storage and distribution environments. By measuring leak rates directly, it avoids reliance on estimated or modelled data. This approach provides a more accurate understanding of package performance across the full range of expected conditions, including cold chain applications.

Adaptability Across Packaging Formats

Traditional methods like dye ingress and bubble testing cannot reliably detect very small, sub-micron defects. This has led to increased use of more accurate methods such as helium leak detection.

Biologic products are packaged in a variety of formats, including vials, prefilled syringes, and cartridges. Each format presents its own challenges in terms of sealing and integrity.

The SIMS 1915+ is designed to accommodate these different packaging systems, making it suitable for both development stage and routine production testing. Its flexibility allows manufacturers to apply a consistent and reliable testing approach across multiple container types. This helps maintain uniform quality standards while simplifying testing processes across the product lifecycle.

Conclusion

The SIMS 1915+ is widely used to support the integrity of high-value biologic packaging. It is capable of identifying very small leaks, measuring true leak rates, and delivering results without delay. The system also performs effectively at low temperatures and can be applied across a range of packaging formats.

PTI's helium leak testing technology is used to detect micro leaks in packaging such as vials, syringes, cartridges, foil pouches, and blister packs. By focusing on direct measurement rather than estimation, it provides clear and reliable data that supports informed decision-making. This helps improve confidence in packaging performance while maintaining product quality and safety throughout development and distribution.