Höyrydepyrogenointi

Höyrydepyrogenointi, also known as steam depyrogenation, is a sterilization process used to eliminate pyrogens, which are fever-inducing substances often originating from bacterial endotoxins. This method leverages high-temperature steam to break down the molecular structure of these pyrogens, rendering them non-pyrogenic. The process typically involves exposing medical devices, pharmaceutical packaging, or other susceptible materials to saturated steam at elevated temperatures, often above 200 degrees Celsius, for a specific duration. The effectiveness of steam depyrogenation relies on the combination of heat and moisture, which facilitates the denaturation and degradation of pyrogenic molecules. This technique is widely employed in the pharmaceutical and medical device industries due to its efficacy and relatively straightforward implementation. It is a critical step in ensuring the safety and sterility of injectable drug products and other parenteral medical supplies, preventing adverse patient reactions associated with pyrogen contamination. The process parameters, including temperature, time, and steam quality, are carefully controlled and validated to achieve the required level of pyrogen reduction.