Method for steam sterilization of medical articles

摘要

The invention relates to a method for thermal sterilization in particular of a container filled with medical material or product, the method comprising a sterilization method step in which a thermal sterilization in particular is carried out of a container filled with medical material or product in the presence of a sterilization atmosphere, containing steam, at temperatures of at least 100° C. and at increased pressure, wherein the sterilization method step comprises at least a first method stage and a second method stage, following the first method stage, with first and second method stages being carried out at different pressures with respect to one another, the pressure in the second method stage being increased relative to the pressure in the first method stage.

主权项

1. A method for thermal sterilization of a medical container filled with a liquid or flowable medical material or product, wherein the method comprises a sterilization step where a container filled with a medical material or product is subjected to a thermal sterilization in the presence of a sterilization atmosphere containing steam, at temperatures of at least 100° C. and at an increased pressure,
wherein the sterilization step is preceded by a heating step; wherein the sterilization step is carried out in a relative pressure range of between 0.05 and 10 bar or in an absolute pressure range of between 1.05 bar and 11 bar; wherein the sterilization step comprises at least a first stage and a second stage following the first stage, wherein the first and second stages are each carried out at different pressures with respect to one another, wherein the pressure in the second stage is increased relative to the pressure in the first stage, wherein the relative pressure increase from the first to the second stage of the sterilization step is at least 0.01 bar and wherein the pressure increase from the first to the second stage of the sterilization step is effected by introducing air; and wherein the sterilization is followed by a cooling step wherein during the cooling step, a supporting pressure is applied at least temporarily, such that the pressure present in the medical container filled with medical material or product is counteracted.