Which ingredient type signifies a High Risk CSP?

A High Risk Compounded Sterile Preparation (CSP) is defined by the presence of non-sterile ingredients at any point during the compounding process. This can include sources of contamination that may arise from the use of non-sterile components, such as powders, solutions, or any substance that has not undergone sterilization before compounding. The inclusion of non-sterile ingredients elevates the risk of microbial contamination, which is a primary concern when preparing products intended to be sterile.

High Risk CSPs are also characterized by other factors, such as compounding in non-sterile environments or involving processes that expose the preparation to conditions that may lead to contamination before sterilization. Understanding this classification helps ensure that appropriate safeguards, such as additional sterilization methods or more stringent quality control measures, are applied to mitigate the increased risk of infection or adverse reactions in patients.

In contrast, sterile ingredients, single-use vials, and filtered solvents do not inherently signify a high-risk level. Sterile ingredients, as the name suggests, are already free from microbial contamination and would not contribute to the risk factor. Single-use vials and filtered solvents can be safely utilized in sterile preparations when handled properly and used in accordance with appropriate standards. Thus, the