We have carried out tests for the company Abnoba to determine the gas tightness of filled glass ampoules. Read more about the results of this cooperation in the article for “Pharmind – The pharmaceutical industry” in the 08-2022 edition.
What is it about?
The development and validation of a product-specific test of filled glass ampoules for gas tightness by means of indicator reaction are described. Injectable medicinal products from the company Abnoba are produced under the exclusion of atmospheric oxygen, inert gassing by means of argon and with isotonic, isohydric ascorbate-phosphate buffer solution and filled into clear glass ampoules under inert gassing with argon gas. In case of damage, atmospheric oxygen penetrates the interior of the ampoule and leads to oxidation of the ascorbic acid and thus to a clearly visible, permanent discoloration of the ampoule contents to brownish, visible to the naked eye. In experiments with artificially damaged ampoules, it was shown that the gas exchange is strongly dependent on temperature and that storage temperature has a considerable influence on the durability of the ampoules.
How big do microorganisms need to be to penetrate the ampoules?
To specify the defect size below 10 μm, tests with product-filled ampoules with built-in test leakage were carried out at Hilgenberg GmbH.
Read the entire article here.
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