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Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
A monoclonal antibody drug product (DP) manufacturing process was transferred to a different production site, where aseptic filling took place within an isolator that was sanitized using vapor phase hydrogen peroxide (VPHP). A quality-by-design approach was applied for study design to understand the impact of VPHP uptake in the isolator on DP quality. A combination of small-scale and manufacturing-scale studies was performed to evaluate the sensitivity of the monoclonal antibody to hydrogen peroxide (H2O2) as well as VPHP uptake mechanisms during the filling process...
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
N P McLeod, M Clifford, J M Sutton
Geobacillus stearothermophilus spores on stainless steel discs are routinely used as biological indicators for the validation of hydrogen peroxide bio-decontamination processes. Given ongoing concerns about the reliability and response time of biological indicators, we explored the potential for an enzyme-based approach to decontamination process evaluation. Thermostable adenylate kinase enzyme was coated onto a solid support and exposed to hydrogen peroxide vapour, in parallel with standard commercial 6-log biological indicators, during a series of vapour-phase hydrogen peroxide cycles in a flexible film isolator...
September 2017: PDA Journal of Pharmaceutical Science and Technology
Ada Hui, Xanthe M Lam, Christopher Kuehl, Ulla Grauschopf, Y John Wang
UNLABELLED: When isolator technology is applied to biotechnology drug product fill-finish process, hydrogen peroxide (H2O2) spiking studies for the determination of the sensitivity of protein to residual peroxide in the isolator can be useful for assessing a maximum vapor phase hydrogen peroxide (VPHP) level. When monoclonal antibody (mAb) drug products were spiked with H2O2, an increase in methionine (Met 252 and Met 428) oxidation in the Fc region of the mAbs with a decrease in H2O2 concentration was observed for various levels of spiked-in peroxide...
July 2015: PDA Journal of Pharmaceutical Science and Technology
Jirí Svrcek, Antonín Marhoul, Petr Kacer, Marek Kuzma, Libor Pánek, Libor Cervený
Vapor phase hydrogen peroxide (VPHP) nowadays finds more and more applications especially as a bio-decontamination agent for enclosed areas. Although this oxidizing agent logically offers a potential for the degradation of hazardous chemical contaminants, the information on the utilization within this area is very limited. The main objective of this study was to examine in detail the influence of basic operational (temperature, concentration of VPHP, relative humidity, condensation) and other conditions (e...
October 2010: Chemosphere
Hideharu Shintani
An advantage of vapor phase hydrogen peroxide (VPHP) is that it can readily react to form reactive free radicals, which perform the sterilization and form water and hydrogen by catalyst. Absorptive hydrophilic materials such as cellulosics hinder penetration due to hydrogen bonding and necessitate the use of hydrophobic materials, i.e., polyethylene or polypropylene, as packaging materials. The 8h TWA (time-weight-average) is 1 ppm. Hydrogen peroxide sterilization is now being used for the sterilization of gloveboxes, freeze dryers, isolators and endoscopes and so on...
March 2009: Biocontrol Science
Y Ikarashi, T Tsuchiya, A Nakamura
A new sterilization system using vapour-phase hydrogen peroxide (VPHP) was recently developed. The cytotoxicity of various medical materials sterilized by the VPHP sterilization system was investigated. After VPHP sterilization, polystyrene, polyurethane (PU8), blend material of silicone and polyurethane (Sil/PU6), poly(methyl methacrylate) (PMMA), fluorosilicone acrylate and poly(2-hydroxyethyl methacrylate) (HEMA) showed strong cytotoxicity, whereas polyethylene and polypropylene did not. Although the cytotoxic potential of most materials is reduced by extension of the aeration time, HEMA and PMMA still retained strong cytotoxicity after 12 h aeration...
February 1995: Biomaterials
N A Klapes, D Vesley
The feasibility of utilizing vapor-phase hydrogen peroxide (VPHP) as a surface decontaminant and sterilant was evaluated in a centrifuge application. The prototype VPHP decontamination system, retrofitted into a Beckman L8-M ultracentrifuge, was designed to vaporize a 30% (wt/wt) solution of aqueous hydrogen peroxide continuously injecting and withdrawing VPHP in a deep-vacuum flow-through system. VPHP cycles of 4, 8, 16, and 32 min were examined for cidal activity against spores of Bacillus subtilis subsp...
February 1990: Applied and Environmental Microbiology
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