Which of the following is an example of a condition that classifies a product as high-risk sterile?

A product is classified as high-risk sterile if it involves conditions that significantly increase the likelihood of contamination. In the context of sterile compounding, products prepared under high-risk conditions pose a higher risk because they may compromise patient safety due to sterility assurance.

The specific condition that qualifies a product as high-risk sterile is the involvement of non-sterile ingredients or products mixed together without sufficient documentation and control measures. This might occur in a situation where non-sterile mixing takes place in an environment that does not adequately prevent contamination. The lack of proper documentation indicates that the preparation process did not follow the stringent guidelines necessary for maintaining sterility, thereby presenting a significant risk of microbial contamination.

On the other hand, being stored in a cleanroom environment, prepared in closed systems, or having garbed personnel handling ingredients does not inherently classify a product as high-risk. These factors are generally associated with good practices and efforts to maintain sterility, rather than indicating a high-risk condition. Cleanroom storage and the presence of garbed personnel suggest adherence to proper sterile techniques, while closed systems are designed to minimize contamination risk.