sterilitetsstyrning

Sterilitetsstyrning, often translated as sterility control or sterility management, refers to the systematic processes and procedures implemented to ensure and maintain the sterility of products, particularly in healthcare and pharmaceutical settings. The primary goal of sterilitetsstyrning is to prevent microbial contamination, which can lead to infections, product spoilage, and significant health risks.

This discipline encompasses a range of activities. It begins with the design and validation of sterilization methods, such as autoclaving, ethylene oxide sterilization, or irradiation, to ensure they effectively eliminate microorganisms. Rigorous testing and monitoring of sterilization equipment are crucial to confirm its ongoing efficacy. Furthermore, sterilitetsstyrning involves the careful control of the manufacturing environment, including air quality, surface disinfection, and personnel practices, to minimize the introduction of contaminants.

Quality control measures play a vital role, involving regular sampling and testing of both raw materials and finished products to verify their sterility. Documentation and record-keeping are integral, providing a traceable history of all sterilization processes and quality checks. Deviations from established protocols are investigated, and corrective actions are implemented to prevent recurrence. The overarching aim is to provide assurance that products are free from viable microorganisms.