caa a22 4500 477126855 CHVBK 20180405111652.0 cr unu---uuuuu 170330e19970301xx s 000 0 eng 10.1023/A:1012085702372 doi (NATIONALLICENCE)springer-10.1023/A:1012085702372 Near-Infrared (NIR) Monitoring of H2O2 Vapor Concentration During Vapor Hydrogen Peroxide (VHP) Sterilisation [Elektronische Daten] [S. Corveleyn, G. Vandenbossche, J. Remon] Purpose. There is an increasing use in the pharmaceutical industry of barrier systems such as transfer isolators, sterilisation tunnels and work station isolators. As Vapor Hydrogen Peroxide (VHP) sterilisation of isolators and lyophilizers becomes an important sterilisation method, there is an acute need for a VHP monitoring system to be used for in-process control and validation. In this study, near infrared (NIR) spectrofotometry was evaluated as a potential technique to monitor hydrogen peroxide. Additionally the H2O2 vapor permeability of different packaging materials, commonly used in steam and ethylene oxide sterilisation, was evaluated. Methods. NIR spectrofotometry, using a gas cell connected with optic fibres, was evaluated as a potential technique to monitor hydrogen peroxide vapor and water vapor during VHP sterilisation of an isolator. A NIR spectrum was taken every 30 s during VHP sterilisation of an isolator. The influence of injection rate, air flow rate, working temperature and gas distribution was investigated. The H2O2 vapor permeability of different packaging materials was determined by placing the gas cell in the sterilisation bags and sealing the bags hermetically. The sterilisation bag was then subjected to VHP sterilisation. Results. The NIR spectra taken at steady state sterilization conditions showed 4 absorption peaks: at 1364,1378 and 1400 nm attributed to water and at 1420 nm attributed to H2O2 vapor. By measuring the absorbance level at these wavelengths, the actual concentration of H2O and H2O2 vapor in the isolator was calculated. The water vapor permeation of the sterilisation bags, measured with NIR, appeared to be equal for all materials tested. Whereas Tyvek® was the most permeable material for hydrogen peroxide vapor (82.7% of the reference concentration outside the bag), only 30% was found in bags made of medical paper. Sterilisation bags consisting of laminate films and PVC sealed to medical paper showed intermediate permeability. Conclusions. Near-infrared (NIR) spectroscopy using a gascell with optic fibres is a useful technique to monitor VHP sterilisation cycles. There was a difference in H2O2 vapor permeability of different packaging materials, commonly used in steam and ethylene oxide sterilisation. Plenum Publishing Corporation, 1997 hydrogen peroxide monitoring nationallicence near-infrared nationallicence VHP sterilisation nationallicence Corveleyn S. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Gent, Harelbekestraat 72, B-9000, Gent, Belgium aut Vandenbossche G. Alcon Belgium, Rijksweg 14, B-2870, Puurs, Belgium aut Remon J. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Gent, Harelbekestraat 72, B-9000, Gent, Belgium aut Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/3(1997-03-01), 294-298 0724-8741 14:3<294 1997 14 11095 https://doi.org/10.1023/A:1012085702372 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1012085702372 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Corveleyn S. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Gent, Harelbekestraat 72, B-9000, Gent, Belgium aut NATIONALLICENCE 700 1- Vandenbossche G. Alcon Belgium, Rijksweg 14, B-2870, Puurs, Belgium aut NATIONALLICENCE 700 1- Remon J. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Gent, Harelbekestraat 72, B-9000, Gent, Belgium aut NATIONALLICENCE 773 0- Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/3(1997-03-01), 294-298 0724-8741 14:3<294 1997 14 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer