100 % Container Closure Integrity Testing of Lyophilized Drug Products by the Oxygen Head Space Analysis Methodology

Rubrik: Originale

(Treffer aus pharmind, Nr. 05, Seite 739 (2015))

Posset T | Schleger M | Lim F | Mumenthaler M | Schneider S | Kaiser T

100 % Container Closure Integrity Testing of Lyophilized Drug Products by the Oxygen Head Space Analysis Methodology / Determination of minimum Hold Times for Detection of Blue Dye/Microbial Ingress Leak Rates · Posset T, Schleger M, Lim F, Mumenthaler M, Schneider S, Kaiser T · ¹ Parenteral Production, Roche Diagnostics GmbH; Mannheim
² Late Stage Pharmaceutical and Processing Development, Genentech, a member of the Roche Group; California (USA)
³ Biologics Manufacturing Sciences and Technology Drug Product, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
⁴ Pharmaceutical Development & Supplies , F. Hoffmann-La Roche Ltd, Basel (Switzerland)
⁵ Biologics Technology Transfers, F. Hoffmann-La Roche Ltd, Basel (Switzerland) und
leak detection lyophilisation blue dye helium leak testing ingress testing methodologies headspace analysis In aseptic filling processes, sterile filtered drug product solutions are filled in a class 100 environment into sterilized primary packaging components. Since many protein-based drug products cannot be sterilized in the final container post-filling, it is important that contamination be prevented throughout the production process and that the product be manufactured under aseptic conditions. After manufacture, the container closure system must be shown to maintain product integrity and completely block the ingress of microorganisms [ 1 ]. This is ensured primarily by microbiological validation of the packaging ...