How often must media fill testing be conducted for high risk compounded sterile preparations?

Media fill testing is a critical component of ensuring the sterility of compounded sterile preparations, particularly those classified as high risk. Performing media fill testing assesses the ability of the compounding process to maintain sterility throughout the compounding and storage phases. For high-risk compounded sterile preparations, the standard practice is to conduct media fill testing every 6 months.

This frequency is established in guidelines to ensure that compounded products are produced under conditions that minimize the risk of contamination. High-risk preparations involve more complex manipulation, such as the use of non-sterile ingredients or extended storage times before administration, which makes regular testing crucial to maintain patient safety and product integrity.

By performing media fill testing semi-annually, compounding sterile preparation facilities can identify potential issues with their aseptic technique, equipment, or environmental controls promptly, enabling them to take corrective actions as necessary. This proactive approach helps in sustaining the quality and safety of high-risk compounded products, protecting patients from potential infections or adverse reactions associated with contaminated preparations.