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| Naji, M. |
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| Motta, Antonella |
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| Aletan, Dirar |
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| Mohamed, Tarek |
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| Ertürk, Emre |
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| Taccardi, Nicola |
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| Kononenko, Denys |
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| Petrov, R. H. | Madrid |
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| Alshaaer, Mazen | Brussels |
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| Bih, L. |
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| Casati, R. |
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| Muller, Hermance |
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| Kočí, Jan | Prague |
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| Šuljagić, Marija |
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| Kalteremidou, Kalliopi-Artemi | Brussels |
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| Azam, Siraj |
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| Ospanova, Alyiya |
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| Blanpain, Bart |
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| Ali, M. A. |
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| Popa, V. |
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| Rančić, M. |
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| Ollier, Nadège |
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| Azevedo, Nuno Monteiro |
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| Landes, Michael |
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| Rignanese, Gian-Marco |
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Paudel, Amrit
Graz University of Technology
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (6/6 displayed)
- 2023Influence of PLGA End Groups on the Release Profile of Dexamethasone from Ocular Implantscitations
- 2022SEDEX—Self-Emulsifying Delivery Via Hot Melt Extrusioncitations
- 2020Towards an Understanding of the Adsorption of Vaporized Hydrogen Peroxide (VHP) Residues on Glass Vials After a VHP Decontamination Process Using a Miniaturized Toolcitations
- 2018Pharmaceutical-grade oral films as substrates for printed medicinecitations
- 2012Relating Hydrogen-Bonding Interactions with the Phase Behavior of Naproxen/PVP K 25 Solid Dispersions: Evaluation of Solution-Cast and Quench-Cooled Filmscitations
- 2010Theoretical and Experimental Investigation on the Solid Solubility and Miscibility of Naproxen in Poly (vinylpyrrolidone)citations
Places of action
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article
Towards an Understanding of the Adsorption of Vaporized Hydrogen Peroxide (VHP) Residues on Glass Vials After a VHP Decontamination Process Using a Miniaturized Tool
Abstract
<p>Isolators for aseptic filling of biopharmaceuticals and vaccine products are commonly sanitized by vaporized hydrogen peroxide (VHP). However, remaining traces of H<sub>2</sub>O<sub>2</sub> may contaminate the solution and cause oxidative degradation of the pharmaceutical products. The present report aims to establish a thorough understanding of the factors influencing H<sub>2</sub>O<sub>2</sub> adsorption on empty glass intended for pharmaceutical product filling. A lab-scale miniaturized set-up that mimics the VHP- based isolator decontamination process was used. A fractional factorial design of experiment (DoE) was performed including relative humidity (RH), VHP concentration and exposure time as variables. The results revealed that VHP concentration and RH both impacts significantly the extent of H<sub>2</sub>O<sub>2</sub> adsorption on the surface of glass vials and rubber stoppers. The lower extent of H<sub>2</sub>O<sub>2</sub> adsorption at elevated RH implies the existence of competitive co-adsorption. Thus, adsorbed H<sub>2</sub>O<sub>2</sub> may be removed more efficiently from the isolator after the decontamination phase by insufflating air with a high %RH rate during the isolator's aeration phase. The understanding gained from the present set-up can be applied to optimize the design of isolator decontamination cycles and evaluate the trade-off between process performance and the resulting product quality.</p>