Leak detection for lyophilized products with HSA O2

The HSA O2 system detects leaks produced by the finest cracks, in applications in which regular high voltage leak testing is not possible due to insufficient electrical conductivity, as it is for freeze-dried products. Using this process, containers with an internal diameter of 16 mm or more can be inspected reliably.

A laser beam which is tuned to a specific range of wavelengths is directed through the vial above the lyo cake. Oxygen molecules absorb a specific wavelength: the more oxygen there is in the vial, the greater the deviations from a predetermined limit value. It is essential for reliable leak detection that the product is filled

  • in a controlled atmosphere, with no or only a small, defined oxygen content
  • at low pressure, and
  • that it is stored for a time

HSA O2 - oxygen-based headspace analysis

HSA O2 is a spectroscopic process that detects leaks indirectly, by analysing the oxygen content in the gas zone of the container, i.e. between product and stopper, using a laser beam and a photographic sensor.

Freeze-dried products are generally sealed at low pressure in a controlled atmosphere, with no or only a small, defined oxygen content. This means that after closure, leaky containers are susceptible to penetration from ambient air, the quantity of which is determined by two parameters: the interval between lyophilisation and inspection, and the ambient pressure upon closure.

The greater the vacuum in the container, the quicker the ambient air is able to penetrate by way of pressure equalization. And the less oxygen the controlled atmosphere has from the start, the clearer will be the measurable discrepancy in the event of a leak. Also through diffusion O2 penetrates slowly to balance inside and outside oxygen content (21% in ambient air). As soon as the content of O2 reaches 17% inside the container it can be detected reliably.

Depending on the underlying conditions, even the smallest leaks can be detected in this way. An inspection rate of 24,000 containers per hour can be attained, depending on how the machine is configured. The name 'HSA O2' stands for 'Head Space Analyzer' and oxygen (O2).

Advantages of Seidenader HSA O2

One basic advantage of the HSA system is that as an inspection station, it can be integrated into any standard automatic machine from Seidenader. The expenditure for investment and maintenance is comparatively low, as

  • no separate machine is needed,
  • and moreover no additional production space is required.

Subject to individual testing, it is also possible to retrofit the system to existing Seidenader machines. If required, an HSA O2 system can also be configured as a stand-alone HSA SOLO on the smallest Seidenader machine platform.

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           HSA O2
           Leak testing for lyo products.

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