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Sie suchen in allen Bereichen nach dem Autor Mertens A.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenEvaluation of Sterilization Wrapping
Rubrik: GxP
(Treffer aus pharmind, Nr. 08, Seite 751 (2024))
Evaluation of Sterilization Wrapping / For Compliance with EU Annex 1 · Mertens A, Buthe R · STERIS
Autoclave pouches Sterilization wrapping Tyvek Annex 1 Contamination Control Strategy European Union Good Manufacturing Practice Annex 1 [ 1 ] requires pharmaceutical manufacturers producing sterile drug products to implement a Contamination Control Strategy (CCS) to minimize risk of contamination in their manufacturing processes. One source of contamination is materials entering the cleanroom area. The selection and evaluation of these materials is critical as expressed in EU GMPs Annex 1, Section 8.48: “Where materials, equipment, components and ancillary items are sterilised in sealed packaging or containers, the packaging should be qualified for minimizing the risk of particulate, microbial, endotoxin/pyrogen or chemical contamination, and for compatibility with ...
