Pharmaceutical containers need reliable seals to protect their contents from external contamination and maintain package integrity. Detecting small leak paths is therefore an important part of container closure integrity testing (CCIT). SIMS 1915+ Technology combines helium tracer gas with mass spectrometry to identify leakage and provide quantitative leak-rate measurements.
SIMS 1915+ Technology is used for high-sensitivity leak detection because it can detect and quantify very small helium leaks. The technology uses helium as a tracer gas and a mass spectrometer to measure helium passing through a potential leak path. It can measure leak rates as low as 1 × 10?¹° mbar·L/sec and can be configured for pharmaceutical packaging applications, including cold and ultra-cold testing.
How Can Leak-Rate Data Support Package Development?
Quantitative leak-rate data can help manufacturers assess packaging performance during development and testing. The results can be used to compare package designs, evaluate sealing configurations and identify potential leakage issues.
For example, when comparing two closure designs, measured leak rates can help determine which configuration performs better under the same test conditions. This information can support packaging decisions before a design is finalized.
How Does SIMS 1915+ Detect Small Leak Paths?
The technology uses the detection properties of helium to locate and measure leakage. Helium is chemically inert and can pass through very small openings, making it suitable as a tracer gas for sensitive leak testing.
A typical testing process involves:
- Helium introduction into or around the package, depending on the test configuration.
- Leakage through a defect if a continuous leak path is present.
- Helium detection by the mass spectrometer.
- Leak-rate measurement to quantify the detected leakage.
SIMS 1915+ Technology can measure leak rates down to 1 × 10?¹° mbar·L/sec, supporting the evaluation of small leakage paths that may not be apparent through visual inspection.
What Makes SIMS 1915+ Suitable for High-Sensitivity Testing?
| Feature |
How it Works |
Benefit |
| Helium tracer gas |
Uses helium to trace leaks |
Helps find very small leaks |
| Mass spectrometry |
Detects helium from a leak |
Provides sensitive detection |
| High sensitivity |
Measures very low leak rates |
Helps detect small leak paths |
| Quantitative results |
Provides measurable leak-rate data |
Supports clear test evaluation |
| Flexible test configurations |
Can be adapted to different package |
Supports various pharmaceutical packages |
Which Pharmaceutical Packages Can Be Tested?
SIMS 1915+ Technology can be adapted to different pharmaceutical packaging configurations. The fixture and test method are selected according to the package design and the sealing interfaces being evaluated.
| Package type |
Example testing focus |
| Vials |
Container and closure interfaces |
| Pre-filled syringes |
Plunger, barrel, needle, or luer-related interfaces |
| Blister cards |
Sealed areas and package integrity |
| Foil pouches |
Sealed sections and potential leak paths |
| Bottles |
Container and closure interfaces |
Custom fixtures can be used when a package requires a specific test configuration.
Can SIMS 1915+ Support Temperature-Specific Testing?
Yes. SIMS 1915+ Technology can be configured for room-temperature and specified cold-temperature testing. This can help manufacturers evaluate package integrity under conditions relevant to their testing requirements.
The test procedure should define the required temperature, sample preparation and measurement conditions. These factors are important when comparing results obtained under different conditions.
Key Takeaways
SIMS 1915+ Technology uses helium and mass spectrometry to detect and measure small leaks in pharmaceutical packaging. It provides quantitative leak-rate data and supports container closure integrity testing across various packaging formats and temperature conditions.
The technology can be used for testing vials, pre-filled syringes, cartridges, blister cards, foil pouches, and bottles, depending on the test requirements and configuration.
Frequently Asked Questions
1.What is the sensitivity of SIMS 1915+ Technology?
The technology can measure leak rates as low as 1 × 10?¹° mbar·L/sec.
2.Why is helium used in SIMS 1915+?
Helium is chemically inert and can pass through small leak paths. The mass spectrometer detects the helium associated with leakage and allows the leak rate to be measured.
3.Can SIMS 1915+ be used for low-temperature testing?
Yes. SIMS 1915+ Technology can be configured for testing under specified cold and ultra-cold temperature conditions.
