What is the objective of determining the sterility assurance level (SAL)?

Determining the sterility assurance level (SAL) is fundamentally about confirming that sterilization methods are effective. The SAL represents the probability of a viable microorganism remaining on a product after a sterilization process. Typically, a common SAL benchmark is 10^-6, indicating that there is only a 1 in a million chance that a viable microorganism is present after the sterilization process has been applied.

Understanding and ensuring the SAL is critical in sterile compounding because it directly relates to the safety of the medication for patient use. A precise SAL demonstrates that the sterilization procedure has effectively reduced the risk of microbial contamination to an acceptable level, thereby safeguarding patient health. It is an essential component of quality assurance in sterile manufacturing, ensuring that sterilization techniques are performing as intended to produce safe and effective medications.

While factors such as cost and efficiency in the compounding process are indeed important considerations in the overall manufacturing of sterile products, they do not capture the foremost aim of establishing a sterility assurance level, which is focused on the efficacy of sterilization methods.