What is the required testing frequency for media fill in low-risk CSPs?

For low-risk compounding sterile preparations (CSPs), the required testing frequency for media fills is annually. This requirement is based on guidelines established by professional organizations such as the United States Pharmacopeia (USP) and the Pharmacy Compounding Accreditation Board (PCAB).

Annual testing ensures that compounding practices maintain aseptic techniques and that personnel are consistently demonstrating proper sterile compounding procedures. By conducting media fill tests at least once a year, pharmacies can effectively monitor and confirm the competency of their staff in creating sterile products and reduce the risk of contamination.

This frequency is sufficient to ensure that any potential changes in technique or environmental conditions are addressed, while also balancing the operational capabilities of the compounding pharmacy. More frequent testing is typically required for higher-risk compounding categories, but for low-risk CSPs, an annual frequency meets safety guidelines and industry standards.