Which USP chapter is associated with sterilization and sterility assurance of compendial articles?

The chapter that focuses on sterilization and sterility assurance of compendial articles is USP 1211. This chapter provides guidance specifically on the various methods of sterilization, including their effectiveness and the importance of validating sterilization processes to ensure the sterility of pharmaceutical products. It discusses different sterilization techniques, such as moist heat sterilization, dry heat sterilization, and others, highlighting their application in manufacturing processes where sterility must be assured.

This chapter is crucial for professionals involved in sterile compounding and pharmaceutical manufacturing, as it outlines standards and practices to ensure that products are free from viable microorganisms. Understanding and adhering to the principles set forth in this chapter is essential for maintaining the integrity and safety of sterile products.

While other USP chapters mentioned may also relate to sterile compounding, they serve different purposes. For example, USP 797 primarily deals with the sterile compounding environment and procedures but does not focus explicitly on sterilization processes used or sterility assurance as USP 1211 does. Thus, USP 1211 is the appropriate reference for sterilization and sterility assurance in the context of compendial articles.