sterilointidose

Sterilointidose refers to the specific amount of a sterilizing agent, such as radiation or a chemical compound, required to achieve a defined level of microbial inactivation. This dose is critical in processes designed to eliminate or reduce microorganisms to a level that renders a product safe for its intended use, particularly in medical, pharmaceutical, and food industries. The concept is rooted in the understanding that different microorganisms exhibit varying sensitivities to different sterilizing agents.

The target for sterilization is typically expressed as a Sterility Assurance Level (SAL), which is the probability of a single item remaining non-sterile after the sterilization process. A common SAL for medical devices is 10⁻⁶, meaning there is a less than one in a million chance of a non-sterile item. Achieving a specific SAL necessitates a precisely determined sterilizing dose. Factors influencing this dose include the type and concentration of microorganisms present, their resistance, the physical and chemical properties of the product being sterilized, and the characteristics of the sterilizing agent itself, such as radiation intensity or chemical concentration and contact time.

For radiation sterilization, the dose is measured in Grays (Gy) or kilograys (kGy). Chemical sterilization involves specific concentrations and exposure times of agents like ethylene oxide or hydrogen peroxide. Validation studies are essential to confirm that the chosen sterilizing dose consistently achieves the desired SAL under defined conditions. This ensures the efficacy and safety of the sterilization process.