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Maintaining the integrity of products from the time it is manufactured to the time it is distributed to the patient is a great challenge. Liquid pharmaceuticals, capsules, and formed tablets are typically packaged in bottles. To assure the quality of these items, leak testing is carried out on each bottle to ensure that it does not leak. Testing pharmaceutical bottles or pharmaceutical package leak detection before filling is a critical step in ensuring the integrity of the container.

Helium leak testing is one of the most sensitive Container Closure Integrity (CCI) testing techniques that can be applied to pharmaceutical bottles for testing quality. Helium is used as a tracer gas, and the quantity of helium leaving through the package is measured and stated as leak rate. Since it is non-toxic, non-flammable, and non-condensable, helium is an ideal tracer gas for finding leaks. Its atmospheric presence is restricted to 5ppm. Due to its tiny atomic size, helium can easily pass-through leaks. Helium is also safe to use since it does not react with the materials of the components under test.

Significance of Helium Mass Spectrometry in Leak Testing Pharmaceutical Bottles

Helium mass spectrometry is a leak detection standard for pharmaceutical containers including bottles. Helium mass spectrometer, a commonly used instrument detects and locates tiny leaks. It usually works with a vacuum chamber and a sealed container filled with helium. A mass spectrometer detects the rate at which helium is leaking out of the container. This method uses tracer gas - helium to fill the product attached to the detector. The tested product leaks helium into the detector, where its partial pressure is measured and displayed.

The leak detector's principle is based on a sector field mass spectrometer. In vacuum, entering helium gases are ionized. The helium ions are then accelerated by adding voltage and then separated in a magnetic field. The ion current is converted to an electric current by using a particular detector. This current is accelerated using leak detection units and displayed on the screen. The current measured will be directly proportional to the concentration of helium and therefore equal to the leak measured.

Applications of Helium Leak Detection

• Ensure container closure integrity.
• Seal integrity monitoring during stability studies.
• Verify and predict shelf-life seal integrity.
• Useful in the early stages of the development of a pharmaceutical product packaging system.
• Closure formulation and configuration selection.

Bottles are useful in the healthcare industry, hence evaluating them is a challenging task nowadays. These containers are extremely difficult to test, however, helium leak detection can be used to qualify them prior to use or as a proof of concept. LDA provides professional engineering solutions for the Active Pharmaceutical Ingredient (API) sterile container testing.