What is the quantity of CSP required for high risk testing?

In the context of high-risk testing for compounded sterile preparations (CSP), the requirements for the number of identical CSPs are specifically designed to ensure that the sterility and quality of the compounded products are rigorously evaluated. High-risk CSPs are those that are compounded from non-sterile ingredients or using non-sterile equipment, which carries a higher risk of contamination.

The established guideline mandates that when conducting sterility testing for high-risk CSPs, it is recommended to prepare more than 25 identical CSPs. This larger quantity allows for an adequate sample size to accurately assess the sterility and can help identify any potential contamination issues that might arise during the compounding process. The intent is to ensure patient safety by verifying that the compounded product meets the necessary sterility standards before distribution.

Hence, the requirement to prepare more than 25 identical CSPs is rooted in the principles of quality control and risk management in sterile compounding, ensuring that thorough testing is conducted to mitigate the risks associated with high-contamination products. This approach stands in contrast to lower-risk compounding, where fewer products may suffice for testing.