2025 Education Track Session

SOPs for Sterile Compounding: Who’s Behind Door #3?

Guidelines for sterile compounding, such as USP, vary in the level of prescriptive details for critical tasks like aseptic technique, cleaning, and disinfection. When the details are not clear enough to establish a standard operating procedure (SOP), users often turn to industry associations, manufacturers, and colleagues for help. This presentation will cover the regulatory, theoretical, and practical perspectives on several key topics, including the management of sterilized supplies, and techniques for cleaning and disinfection.
Guidelines for sterile compounding, such as USP, vary in the level of prescriptive details for critical tasks like aseptic technique, cleaning, and disinfection. When the details are not clear enough to establish a standard operating procedure (SOP), users often turn to industry associations, manufacturers, and colleagues for help. This presentation will cover the regulatory, theoretical, and practical perspectives on several key topics, including the management of sterilized supplies, and techniques for cleaning and disinfection.

Learning Objectives

  • Define the frequencies and procedures for cleaning and disinfection as described in guidelines from USP, FDA, TJC, and other regulatory entities.
  • Identify the gaps between relevant guidelines and the practical implementation of procedures in a clean room suite.
  • Reconcile the best practice recommendations from manufacturers of cleaning and disinfection supplies with the realistic management of supplies inside and outside ISO 5 areas.
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    Registration for the Sterile Compounding Clinic Required