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)
Aseptically processed pharmaceutical products and packages may be exposed to hydrogen peroxide (H 2 O 2 ) throughout the filling and packaging process. While the advantage of the decontamination with H 2 O 2 lies in its harmless end-products water and oxygen, residual hydrogen peroxide may show detrimental effects on sensitive pharmaceutical products, even at trace concentrations. Therefore, the transmission rate of H 2 O 2 through the packaging material (e.g. polymer packaging foils) during a decontamination process needs to be determined to prevent H 2 O 2 ingress into the product. Thus, in this study, a methodology capable of ...