According to USP <797>: “All compounding personnel must perform media-fill testing to assess their sterile technique and related practices initially and every 6 months after.”
USP <797> states, in part:
“When performing a media-fill test, simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person, replacing all the components used in the CSPs with soybean -casein digest media.”
Low Complexity:
The Low Complexity Kit by Hardy Diagnostics is recommended for simulating manipulations, involving vials and transfers, and for verifying aseptic technique. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility.
Medium Basic:
The Medium Complexity Level Kit- Basic by Hardy Diagnostics is recommended for simulating compounding manipulations, and for verifying of aseptic transfer techniques of multiple solutions. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility.
Medium Comprehensive:
Hardy Diagnostics Medium Complexity Level Kit-Comprehensive is recommended for simulating compounding manipulations involving the preparation of IV Bags, and for verifying aseptic technique. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility.
High Complexity:
The High Complexity Level Kit by Hardy Diagnostics is recommended for simulating compounding manipulations and for verifying aseptic techniques of non-sterile to sterile solutions. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. Product is quality control tested for growth promotion and pH.
HVMTK:
Hardy Diagnostics HardyVal™ MTK (Multiple Technician Verification Kit) is recommended for simulating compounding manipulations involving vials, ampoules and bags,and for verifying aseptic technique within a sterile compounding pharmacy facility or other cleanroom application. Each kit contains enough media to perform aseptic technique verification for up to five technicians. Product is quality control tested for growth promotion, pH, and sterility.