Container closure integrity is essential for patient safety as well as pharmaceutical product efficacy, and container closure integrity testing (CCIT) is a critical step in the manufacturing process. A paradigm change is currently taking place in the pharmaceutical industry, moving it away from conventional probabilistic procedures and toward deterministic alternatives. LDA (a PTI Company) dives into the area of CCIT, giving the industry a thorough understanding of its practices and introducing innovative helium leak detection technology.
For non-porous packaging including vials, syringes, and cartridges, helium mass spectrometry has become the new leak detection standard. The approach is favored by producers and authorities because of its greater sensitivity, quicker test times, traceability, and determinism in contrast to the probabilistic conventional methods.
Role of Helium Mass Spectrometry in Leak Testing Vials
Helium mass spectrometry is a leak detection standard for various pharmaceutical packaging formats, including vials. Mass spectrometer leak detector is an equipment often used for discovering and identifying leaks within or outside the product. Typically, it works with a vacuum chamber and a closed container filled with helium. Helium leakage from the container is measured by the mass spectrometer. In this technique, the product connected to the detector is filled with helium tracer gas. Helium from the tested product escapes into the detector, where it is measured and indicated as partial pressure.
The sector field mass spectrometer works as the fundamental component of leak detection. Helium gases are ionized as they enter the vacuum. Next, voltage is added to accelerate the helium ions, which are subsequently separated in a magnetic field. A specific detector is used to change the ion current into an electric current. Utilizing leak detecting units, this current is accelerated and displayed on the screen. The leak will be determined by the current since it is directly proportional to the helium concentration.
Why is Helium Used in Leak Detection?
- It is an inert gas molecule that is among the smallest.
- It may consistently and readily breach pathways due to its small atomic size.
- Helium is non-toxic, non-condensable, and non-flammable.
- Relatively safe to use as it will not interact with the components being tested.
- Helium is less expensive and readily available when compared to other tracer gases.
- There is no more than 5 ppm of helium in the atmosphere.
For Maximum Allowable Leakage Limit (MALL) testing in the pharmaceutical industry, LDA helium leak detection technologies are ideal. It is crucial that you control the tracer gas concentration while doing the measurement to guarantee accuracy. This is particularly challenging when working with vials or other sealed containers. Therefore, LDA (a PTI company) provides solutions to test the integrity of pharmaceutical vials.
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