Small leaks in pharmaceutical and medical device packages can be difficult to identify through visual inspection. When package integrity is important, manufacturers need a leak detection method that can identify very small leak paths and provide measurable results.
Quick Answer:SIMS 1915+ Technology uses helium as a tracer gas and a helium leak detector to identify and quantify very small leaks. It provides quantitative leak-rate data at sensitivity levels as low as 1 × 10?¹° mbar·L/sec, making it suitable for sensitive package integrity and container closure integrity testing.
What Is SIMS 1915+ Technology?
SIMS 1915+ Technology is a helium-based leak detection system designed to identify and measure leaks in pharmaceutical, and combination product packages. It uses helium as a tracer gas and a mass spectrometer to detect helium passing through a leak path.
Unlike methods that provide only an indication of whether a package has a leak, helium leak detection can provide a quantitative leak-rate measurement. This helps manufacturers understand the level of leakage and evaluate package integrity.
How Does SIMS 1915+ Detect Very Small Leaks?
The principle behind SIMS 1915+ is based on helium detection. During testing, helium is introduced to or contained within the test package. If a leak is present, helium moves through the leak path.
The mass spectrometer detects the helium and measures the amount passing through the leak. The result is expressed as a quantitative leak rate.
This makes the technology useful when the test requires high sensitivity and the ability to detect leak paths that may be extremely small.
How Sensitive Is SIMS 1915+?
The SIMS 1915+ is specified for quantitative package analysis at sensitivity levels as low as 1 × 10?¹° mbar·L/sec. This level of sensitivity is useful when manufacturers need to investigate microscopic leak paths in pharmaceutical and medical device packages.
The system can provide measured leak-rate data instead of only indicating whether a package has passed or failed.
Where Is SIMS 1915+ Technology Used?
SIMS 1915+ can be used for different pharmaceutical and medical device applications. These include vials, pre-filled syringes, cartridges, blister cards, and combination products.
Combination products can present additional testing challenges because they may contain multiple components or different sealing interfaces. SIMS 1915+ provides testing options that can be applied to different product configurations.
Can SIMS 1915+ Be Customized for Different Packages?
Yes. SIMS 1915+ systems can be configured according to the package format being tested. Custom vacuum test fixtures can be developed for specific products and package configurations.
The official technology information also notes options for room-temperature and cold-temperature testing, depending on the testing requirements.
What Are the Main Benefits of SIMS 1915+ Technology?
| Features |
How It Helps |
| High sensitivity |
Detects very small leaks |
| Leak-rate measurement |
Provides actual leak-rate values |
| Different package types |
Tests various pharmaceutical and medical packages |
| Custom test fixtures |
Fits different package shapes and sizes |
| Temperature testing |
Supports room and cold-temperature testing |
| Package evaluation |
Helps evaluate package integrity during development and testing |
Conclusion
SIMS 1915+ Technology is used for high-sensitivity leak detection because it combines helium tracer gas with quantitative leak-rate measurement. With sensitivity down to 1 × 10?¹° mbar·L/sec, it can be used to investigate very small leak paths in pharmaceutical and medical device packaging.
The technology can support package development, tooling qualification, production setup, and ongoing package quality monitoring, making it useful across multiple stages of the package lifecycle.
Frequently Asked Questions
1.What is SIMS 1915+ used for?
SIMS 1915+ is used for quantitative helium leak detection and package integrity testing of pharmaceutical, biotechnology, medical device, and other package systems.
2.How does SIMS 1915+ detect leaks?
It uses helium as a tracer gas. When helium passes through a leak, the detection system measures the helium signal and determines the leak rate.
3.What is the sensitivity of SIMS 1915+?
SIMS 1915+ can perform quantitative package analysis at sensitivity levels as low as 1 × 10?¹° mbar·L/sec.
