Application of enzyme indicators in hydrogen peroxide biodecontamination cycle development: A critical evaluation of indicator variability and correlation to biological …

A Schachtschneider, S Klein… - PDA Journal of …, 2022 - journal.pda.org
An important prerequisite for aseptic production of pharmaceuticals is the appropriate
reduction of microbiological contamination. Hydrogen peroxide is commonly applied as …

Evaluation of novel process indicators for rapid monitoring of hydrogen peroxide decontamination processes

NP McLeod, M Clifford, JM Sutton - PDA Journal of Pharmaceutical …, 2017 - journal.pda.org
Geobacillus stearothermophilus spores on stainless steel discs are routinely used as
biological indicators for the validation of hydrogen peroxide bio-decontamination processes …

Risk assessment paradigm: an opportunity for rationalizing the choice of biological indicator during the validation of isolator biodecontamination cycles

E Eansoë-Bourget - PDA Journal of Pharmaceutical Science and …, 2006 - journal.pda.org
The use of biological indicators is integral to the validation of isolator decontamination
cycles. The difficulty in setting up the initial qualification of the decontamination cycle and …

Development and quantification of H2O2 decontamination cycles

V Sigwarth, C Moirandat - PDA Journal of Pharmaceutical Science …, 2000 - journal.pda.org
Whereas correlation of physical process parameters with bacterial reduction is well
established in thermal sterilisation, such a method is currently neither generally recognised …

Development, and modelling a hydrogen peroxide technology as a decontamination process within the Pharmaceutical, Healthcare and Food industries

I Cantera García - 2022 - tdx.cat
Decontamination methods have commonly relied on thermal or chemical non-automated
processes that ensured a minimum microbial reduction. However, in the last decade, the …

[HTML][HTML] Submerged Bioreactor Production of Geobacillus stearothermophilus ATCC 7953 Spores for Use as Bioindicators to Validate Hydrogen Peroxide Inactivation …

P Stier, U Kulozik - Methods and protocols, 2021 - mdpi.com
In the food and pharmaceutical industries, evaluating the sterilization performance
preceding aseptic production processes is of central importance. In the case of hydrogen …

Decision risk approach to the application of biological indicators in vapor phased hydrogen peroxide bio‐decontamination

É Pusztai, S Kemény, E Vágó… - Journal of …, 2018 - Wiley Online Library
The ensuring of sterile conditions during pharmaceutical production is of vital importance.
Restricted access barrier systems may not be sterilized in the usual way. Instead, vaporous …

[HTML][HTML] Real-World Vapor Phase Hydrogen Peroxide Decontamination

J Agalloco - Pharmaceutical Technology, 2020 - pharmtech.com
The introduction of isolation technology in the pharmaceutical industry by the French firm La
Calhene in the 1980s required a means for the reliable microbial decontamination of the …

Suitability of different construction materials for use in aseptic processing environments decontaminated with gaseous hydrogen peroxide

B Unger, U Rauschnabel, B Düthorn… - PDA Journal of …, 2007 - journal.pda.org
The purpose of this study is to examine the behavior of different materials towards the
microbial inactivation kinetic of gaseous hydrogen peroxide. Samples of 49 materials …

[HTML][HTML] Key Words: hydrogen peroxide bacterial spores surface decontamination D-value material properties How to test the resistance of bacterial spores to H 2 O 2 …

S Kemmerling - ecv.de
The efficacy of surface decontamination processes using vapor-phase hydrogen peroxide
(H 2 O 2) can vary on different materials. Bacterial spores on stainless steel carriers are …