TY - JOUR T1 - Suitability of Different Construction Materials for Use in Aseptic Processing Environments Decontaminated with Gaseous Hydrogen Peroxide JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 255 LP - 275 VL - 61 IS - 4 AU - Beatriz Unger AU - Uta Rauschnabel AU - Berthold Düthorn AU - Volker Kottke AU - Christian Hertel AU - Johannes Rauschnabel Y1 - 2007/07/01 UR - http://journal.pda.org/content/61/4/255.abstract N2 - 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 potentially used in aseptic processing environments were inoculated with 106 spores of Geobacillus stearothermophilus ATCC #12980 and exposed to defined periods using a reproducible hydrogen peroxide bio-decontamination cycle. The inactivation characteristic of each material was investigated by means of repeated D-value calculations. The results demonstrate that different materials show highly variable performance regarding the inactivation pattern of spores on each particular surface. Not only the chemical composition of the material but also differences in manufacturing processes and surface treatments were found to have an effect on the resistance of the test organisms. From the data obtained it is concluded that some correlation exists between the calculated D-values and roughness as well as wettability of the materials. Best- and worst-case materials were identified, and the dependence of specific decontamination characteristics on material properties was investigated. It is suggested to integrate studies regarding the inactivation characteristics of incorporated materials into the construction process of new aseptic processing systems bio-decontaminated with hydrogen peroxide. ER -