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Dichtheitsprüfung mittels Plasma-Photometrie

Ein neues Verfahren zur Kontrolle pharmazeutischer Primärverpackungen

Gerhard Poss und Jürgen Wittekind

Battelle Ingenieurtechnik GmbH, Eschborn

Leakage Monitoring by means of Plasma Photometry / A new technique to controI pharmaceutical primary packaging material

The leakage monitoring technique developed by Battelle is mainly dedicated for the control of pharmaceutical, liquid filled Containers like vials and polyethylene-cartridges. The measuring principle uses the effect, that volatile substances e.g. released from aqueous or alcoholic solutions under vacuum enter a gas discharge tube and modify the Optical properties of the plasma. The modification - mainly a decrease of the luminescence -is measured photometrically and corresponds to the leakage rate of the test specimen. Intercomparison with microbiological tests proved plasma photometry being conservative and clearly more selective than microbiological methods and being capable detecting even smallest leakages. The method is suitable for off-line application e.g. in the field of galenic research as well as for in-line control in production lines (100 %-control).

Key words Dichtheitsprüfung · Keimtest · Nachweis von Wasserspuren · Pharmazeutische Primärverpackungen · Prozeßkontrolle