HeLD Methodology
Helium mass spectrometry is best suited for evaluating the inherent integrity of a package system. Leveraging helium in vacuum mode, vials, syringes, cartridges, and bottles can be evaluated to determine whether parameters such as capping pressure, torque ranges, and even components have adverse effects on the integrity of the package system. Additionally, materials from HDPE to Aluminum, as well as sizes of 1mL to 30L can be evaluated given the proper technique and fixture.
Helium filled or flushed samples are placed in a test fixture, where a 1-atm differential vacuum is created by the instrument’s internal pumps. In certain circumstances, specialized fixtures may be created to isolate particular package areas of interest to evaluate the package and component inherent integrity. Leaking samples allow helium to escape, enter the helium leak detector test system, and are then detected by an analyzer cell. The stream of helium ions hitting the analyzer cell target is proportional to the partial pressure inside a sample. From this, a specific leak rate can be calculated and reported to the user. Results can be reported quantitatively (as a leak rate), or qualitatively (Pass or Fail) if method development is performed.
In addition to the suite of CCI testing technologies, the helium leak detection studies allow for an exhaustive feasibility approach to meet your study goals.
Evaluation of the assembly process and its impact on the integrity of the package system have become popularized through the use of HeLD such that capping optimization studies and torque studies have become part of the ever changing CCI landscape.
Defects
DDL utilizes our approved vendor to fabricate laser-drilled defects at particular locations throughout a package system (ref. figure on right). Each one of these Positive Controls come with a certificate of calibration to not only increase traceability, but also to verify the sensitivity of the technique.
Timeline
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