Towards an Understanding of the Adsorption of Vaporized Hydrogen Peroxide (VHP) Residues on Glass Vials After a VHP Decontamination Process Using a Miniaturized Tool.

Adsorption Biopharmaceutical Decontamination Filling Glass vial Isolator Miniaturization Oxidation Vaccine Vaporized hydrogen peroxide

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
08 2020
Historique:
received: 14 02 2020
revised: 10 04 2020
accepted: 13 04 2020
pubmed: 1 5 2020
medline: 22 6 2021
entrez: 1 5 2020
Statut: ppublish

Résumé

Isolators for aseptic filling of biopharmaceuticals and vaccine products are commonly sanitized by vaporized hydrogen peroxide (VHP). However, remaining traces of H

Identifiants

pubmed: 32353452
pii: S0022-3549(20)30205-7
doi: 10.1016/j.xphs.2020.04.012
pii:
doi:

Substances chimiques

Biological Products 0
Hydrogen Peroxide BBX060AN9V

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2454-2463

Informations de copyright

Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Auteurs

Varun Kushwah (V)

Research Center Pharmaceutical Engineering (RCPE) GmbH, Inffeldgasse 13, 8010 Graz, Austria.

Johannes Poms (J)

Research Center Pharmaceutical Engineering (RCPE) GmbH, Inffeldgasse 13, 8010 Graz, Austria.

Bram Vuylsteke (B)

GSK, Technical Research & Development, Drug Product, Rixensart, Belgium.

Anna Peter (A)

Research Center Pharmaceutical Engineering (RCPE) GmbH, Inffeldgasse 13, 8010 Graz, Austria.

Amrit Paudel (A)

Research Center Pharmaceutical Engineering (RCPE) GmbH, Inffeldgasse 13, 8010 Graz, Austria; Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, 8010 Graz, Austria. Electronic address: amrit.paudel@tugraz.at.

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Classifications MeSH