What does the term "sterility assurance level" (SAL) refer to?

The term "sterility assurance level" (SAL) specifically refers to the effectiveness of a sterilization process in ensuring that no viable organisms remain in a product after sterilization. It is a critical parameter in sterile compounding, as it quantifies the risk of a viable microorganism surviving the sterilization process.

In practical terms, an SAL of 10^-6, for instance, indicates that there is only a one-in-a-million chance of a viable organism remaining in the final product, thereby providing a high level of assurance that the product is sterile. This concept is crucial in ensuring patient safety when administering sterile products, as even a single viable organism could lead to serious infections or complications.

Understanding SAL is vital for compounding pharmacists, as it underscores the importance of following validated sterilization methods and maintaining stringent quality control measures during the compounding process.