Rapid Sterility Instrument

The U.S. Food and Drug Administration (FDA) is seeking information from potential vendors about their ability to provide a Rapid Sterility Instrument. The instrument should utilize ATP-bioluminescence technology for microbial detection and be compatible with USP <71> compendial media. It should also be capable of analyzing both filterable and non-filterable pharmaceutical products and have a testing capacity of at least 28 tests per hour. The FDA is looking for a turn-key solution that includes all necessary hardware, components, instruments, computers, and software. • The instrument must be a benchtop model with a footprint no larger than 24 inches x 24 inches x 24 inches. • The system must be delivered with all necessary supplies and accessories required for installation and start-up. • The contractor must provide on-site operator training and familiarization for two users. • The system must be warranted for at least one year from FDA acceptance. • The contractor must provide standard commercial warranty and payment terms.