Helium Leak Detection For Combination Drug Products
There have been many advances over the past decade in terms of drug product delivery methods. As a result, key developments like unique cartridge based delivery systems have become common. It is well documented that Helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applicable to cartridge based delivery systems. In most cases the key to success is the development of a text fixture device designed and manufactured to the specific cartridge system being testing. These custom fixtures for helium leak detection can be designed to isolate specific areas of interest in the cartridge system.
In terms of test method development, the basic principles remain the same. Helium-filled or flushed samples are placed in a test chamber, where a vacuum is created by the instrument’s internal pumps. Any leaking sample will enable helium to evacuate, enter the test system and will then be detected by the instrument’s analyzer cell. The stream of helium ions hitting the analyzer cell target is proportional to the partial pressure inside a sample thereby allowing a specific leak rate to be calculated and reported. Results can be reported quantitatively (as a leak rate), or qualitatively (Pass or Fail) if formal method development is completed.