(Seidenader: Markt Schwaben, Germany) -- The particular attention paid to leak tightness of pharmaceutical containers has been continuously increasing during the past months. Seidenader stays abreast of these changes with the development of a module for head space analysis (HSA). Besides the penetration of oxygen and its possible reaction with the product, the loss of sterility of parenteral products (e.g., injections, infusions) is the most serious threat to the health of patients.

Parenteral products are usually filled with a certain low or high pressure, in other cases, a filling gas diverging from air is added. The head space analysis gives information about the absolute pressure, oxygen content, water partial pressure within the container, and after comparison with the appropriate set values, the vial’s leak tightness. Up to 600 vials per minute and 100 measurements per container are analyzed using tunable diode laser absorption spectroscopy (TDLAS).

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