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"The Basics of Sterilization Knowledge and Manufacturing Standards for Biological Indicators, as well as Sterilization Assurance," is a comprehensive document that covers a wide range of topics from the fundamental knowledge necessary for sterilization assurance to practical applications. It explains the concept of Sterilization Assurance Level (SAL) 10^-6, the selection criteria for biological indicators in accordance with the ISO 11138 series, and the culture conditions. Additionally, it includes examples of calculating D values and Z values for sterilization processes. The content is designed for stakeholders in various fields, including the pharmaceutical industry, medical device industry, and quarantine facilities. **Features** - Explanation of the fundamental knowledge of Sterilization Assurance (SAL) - Introduction of selection criteria for biological indicators based on ISO standards - Presentation of methods for calculating D values and Z values in sterilization processes - Provision of specific guidelines for the design and evaluation of sterilization processes *The document is available for immediate reading via "PDF Download."*