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Sie suchen in allen Bereichen nach dem Autor Knobe J.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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Compliant Handling of Sterile Bulk Components
Rubrik: GxP
(Treffer aus pharmind, Nr. 09, Seite 678 (2026))
Compliant Handling of Sterile Bulk Components / An In-Depth Assessment of Processes Before, During and After Bulk Sterilization · Knobe J · ATEC Pharmatechnik
Primary Packaging Aseptic Transfer Component Processing Contamination Control Annex 1 The term Sterile Component Processing defines a process which ensures the reduction of different kinds of contamination by combining several process steps in one single system. These components are primary packaging components (PPCs), such as pharmaceutical stoppers and caps. Section 8.2 of the EU GMP Annex 1 [ 1 ] states that PPCs must be cleaned using validated procedures to ensure that particles, endotoxins/pyrogens, and microorganisms are appropriately controlled. This article presents an approach that is totally compliant with this section of Annex 1 and fulfils the requirements of Section 3.1 [ 1 ] that all ...
