Rubrik: Reinraum
(Treffer aus TechnoPharm, Nr. 02, Seite 100 (2021))
Widmann C | Ravasio D | Ladwig T
Material selection as a control strategy to limit hydrogen peroxide residuals in drug products / Widmann et al. • Material selection · Widmann C, Ravasio D, Ladwig T · SKAN AG, Allschwil (Switzerland)
Isolator Diffusion Hydrogen Peroxide Decontamination Material Exposure Aseptic Processing The primary benefits of utilizing isolation technology include fewer incidents of microbial and/or particulate contamination introduced by human operators during drug product manufacture. Aseptic production conditions inside the isolator chamber are achieved by circulation of vapor-phase hydrogen peroxide as decontaminating agent. All internal surfaces of the isolator chamber and filling machine are decontaminated by H 2 O 2 , more specifically during the H 2 O 2 decontamination phase. Following H 2 O 2 decontamination, the chamber undergoes an aeration phase which decreases the concentration of residual H 2 O 2 ...