Media Fill Testing
A media fill test is required by United States Pharmacopeia (USP) and state boards of pharmacy to prove that the aseptic technique process can produce a sterile product without contamination. According to USP <797>, any person engaged in sterile compounding must conduct a media fill test:
- Before beginning sterile compounding for three consecutive days to simulate repetitive process competency.
- At least annually for low to medium risk compounding.
- At least semi-annually for high-risk compounding.
Personnel should perform the media fill test under the most stressful and challenging conditions at the pharmacy.
Media fills use sterile microbiological growth media in place of the drug product and simulates all production operations including:
- Preparation and assembly of product containers
- Transfer of product to the fill area
- All process steps downstream from the sterilizing filter up to product release including packaging into finished product containers