Current Edition

Isolators in Aseptic Production and their Requirements for Highly Active Substances

The new EMA (European Medicine Agency) Draft Guide of Annex 1 has drawn a lot of attention to isolators. In the paper, the employee in aseptic production is seen as the greatest risk factor for product contamination, and Richard Denk at SKAN AG demonstrates how contamination is particularly prevalent in areas that handle product in open containers; e.g., when filling pharmaceuticals into vials and syringes they should be protected with suitable barrier systems, such as isolators.

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