Evaporated H2O2 (VHP) as decontamination proceed in production and research

Beside the well-known thermal sterilisation procedures with steam or Hei�luft-Sterilisatoren increasingly in pharmaceutical production as well as in research and development low temperature and/or gas sterilisation procedures is needed. Reasons are the higher requirements to sterility security and the increasing number of applications with those temperature-sensitive materials and materials as well as electrical or electronic devices of a bio decontamination to be submitted are or have. The requirements at the sterilisation and disinfection procedures are generally: micro-biological effectiveness, short process time, safe application, good material compatibility, validation barness and a small environmental impact and not to lastly the economy assigned aspects of procedure with procedure selection in particular became generally accepted with the automated procedures, procedures with hydrogen peroxide. One differentiates between 3 procedures: - Hydrogen peroxide atomising hydrogen peroxide evaporates (Vaporized hydraulic gene of peroxides, VHP) - hydrogen peroxide evaporated and with vacuum pulses (VHP-MD) for the selection for its application at the best suitable H2O2-Verfahrens must the user its requirements weights. The procedures differ in particular by material compatibility, cycle time and penetration of Verpackungsmaterialien.H2O2-Verfahren with generator work, which produce a hydrogen peroxide fog, are a according to device less complex and thus economical solution. However these can be used contently placing only if all materials of the too begasenden volume are steady to condensed Wasserstoffperopxid also. The time after sterilisation phase, needed for the exhaust of the hydrogen peroxide, is longer with these � wet � procedures around much than with � the dry � procedure so called (VHP). With the dry H2O2-Verfahren (VHP) in the generator a gas is produced that in the too begasenden area not when fog is visible. By the consideration of the lowest temperature in the area, the space volume and the loading density the hydrogen peroxide concentration can be always held under the saturation point by a suitable attitude of the cycle parameters. For the maintenance of this condition the crucial cycle parameters are the relationship H2O2-Einspritzrate/air flow and the ambient temperature. Since by the procedure condensation can be avoided, the distance of the hydrogen peroxide possible after the sterilisation phase and reaching the MAK value (permissible maximum job concentration) of 1 are within a short time ppm. The material compatibility of the procedure is so convincing that laboratories with laboratory instruments and also vehicles (ambulances) as well as airplanes with this � drying � H2O2-Verfahren are already decontaminated. Meanwhile also the proof was furnished (space aerations with the MPI in Berlin) that tuberculosis micro bacteria are killed by the procedure. The extensive experiences with this procedure, resulting from many applications in aseptischen production of drugs and over it available publications support the user with the validation component the validation are with the H2O2-Verfahren a cycle development, which includes space/insulator/and surface temperatures of the devices which can be sterilized. For the examination of the gas distribution in addition chemical Indikatorstreifen are used which show a color change with the presence of hydrogen peroxide. An optimal gas distribution is given, if all indicators in the Containment begin themselves approximately at the same time to discolour. For the proof of the biological effectiveness of the H2O2-Verfahren spores Geobacillus Stearothermophilus 105 or 106 are usually used. By comparative studies with other Sporenbildnern, four, bacteria and mushrooms it is often proven that these when admission also� Hydrogen peroxide the longest D-Werte cause. In the further one the proof belongs to a cycle validation that after a decontamination cycle the job limit value is reached surely. The examination in addition can be made e.g. with H2O2-Dr�ger-R�hrchen. With a good environmental compatibility is given all H2O2-Verfahren, since the hydrogen peroxide reduces itself over the time also without catalyst automatically and this happens without toxic arrears. To keep supported this process however by the installation course of the catalysts integrated in the generators around short cycle times.�

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