Sterilitetskrav

Sterilitetskrav refers to the standards and procedures necessary to ensure that a product, particularly a medical device or pharmaceutical, is free from viable microorganisms. This is crucial for preventing infections and ensuring patient safety, especially for items that come into contact with sterile body sites or are administered internally. The requirement for sterility is determined by the intended use of the product. For example, surgical instruments, implants, and injectable medications demand a high level of sterility.

Achieving sterility typically involves validated sterilization processes. Common methods include autoclaving (steam sterilization), ethylene oxide gas sterilization, gamma irradiation, and filtration for liquids. Each method is effective against different types of microorganisms and suitable for different product materials. The effectiveness of these processes is validated through rigorous testing to confirm the absence of microbial life.

Beyond the sterilization process itself, maintaining sterility requires careful control throughout the product's lifecycle. This includes aseptic processing techniques during manufacturing, appropriate packaging that preserves sterility during storage and transport, and proper handling by healthcare professionals. Regular monitoring and revalidation of sterilization processes are also essential to ensure ongoing compliance with sterilitetskrav. Failure to meet these requirements can lead to product recalls, patient harm, and regulatory sanctions.