The FDA's Irvine Medical Products Laboratory in Irvine, CA, seeks a capable small business source to provide a new, rapid sterility testing instrument to accelerate microbiological analysis. The required instrument must use ATP-bioluminescence technology, be compatible with USP <71> methods, provide results in 7 days or less, and have a testing capacity of at least 28 tests per hour. The contractor must deliver, install, and provide on-site training for the complete system within 90 days of award. Capability statements from interested parties, especially small businesses, are being collected for market research purposes only; this is not a formal solicitation.