Hardy Diagnostics’ HardyVal™ Kits provide pharmacy teams with the tools they need for media fill challenge testing, a process that uses sterile growth media to simulate real-world compounding scenarios and verify aseptic technique. These kits are carefully designed to help pharmacies meet USP <797> requirements, which focus on maintaining sterility and controlling microbial contamination during the preparation of compounded sterile preparations (CSPs). By conducting media fill testing with HardyVal™ Kits, pharmacies can validate staff performance and environmental controls to ensure consistent sterility in every batch.
Each HardyVal™ Kit is tailored to meet varying levels of compounding complexity—ranging from low complexity for basic manipulations involving vials and transfers, to high complexity for non-sterile to sterile compounding scenarios. Kits typically include Tryptic Soy Broth (TSB) as the growth medium, sterile serum vials, Whirl-Pak™ bags for easy handling, and comprehensive results log sheets. Importantly, every kit is quality control tested for growth promotion, pH, and sterility, and manufactured in a cGMP and FDA-licensed facility, ensuring that pharmacies can trust the testing process to deliver accurate, reproducible results.
Key Benefits:
- Media Fill Challenge Testing: HardyVal™ Kits simulate aseptic compounding processes, ensuring pharmacy staff and environments meet sterile standards.
- USP <797> Compliance: Essential for verifying that procedures align with regulatory guidelines for compounding sterile preparations.
- Variety of Kits: Low, medium, and high complexity kits meet the needs of different compounding risk levels.
- Quality Assurance: Each kit is rigorously tested and designed for ease of use and accurate documentation.
By using HardyVal™ Kits, pharmacy teams can build confidence in their compounding practices, improve staff proficiency, and safeguard patient health through rigorous testing and process validation.
