Rapid Sterility Instrument

The Food and Drug Administration (FDA) is seeking a Rapid Sterility Instrument to reduce incubation time and provide faster sterility results compared to conventional USP <71> methods. The instrument must utilize ATP-bioluminescence technology, be compatible with USP <71> compendial media, and have a testing capacity of at least 28 tests per hour. The contract type is a firm fixed price commercial item contract. The FDA requires a turn-key solution, including all hardware, components, instruments, computers, software, and necessary supplies for installation and start-up. The contractor must provide on-site operator training and warranty service for at least one year. Key features of the instrument include: • Utilization of ATP-bioluminescence technology for microbial detection • Compatibility with USP <71> compendial media • Testing capacity of at least 28 tests per hour • Automated process of reagent additions and reading of results • Software to control the instrument and obtain results, compliant with 21 CFR Part 11 • Benchtop model with a footprint no larger than 24 inches x 24 inches x 24 inches • Electrical requirement compatible with a standard US outlet, 100-120V, 50 or 60 Hz