Rapid Sterility Instrument

The Food and Drug Administration's Office of Acquisition and Grant Services seeks to procure a Rapid Sterility Instrument capable of reducing incubation time and delivering faster sterility results using ATP-bioluminescence technology for microbial detection. The instrument must be compatible with USP compendial media, accommodate both filterable and non-filterable pharmaceutical products, and provide results within seven days or less with a testing capacity of at least 28 tests per hour. Key requirements include a benchtop design not exceeding 24 inches in each dimension, compliance with 21 CFR Part 11 for controlling software, and operation on standard US 100-120V electrical outlets. The procurement is issued as a Request for Quote (RFQ) under full and open competition, and quotations must be submitted by email to warren.dutter@fda.hhs.gov by April 9, 2026 at 1:00 P.M. Central Time, with prices held firm through September 30, 2026. No specific evaluation criteria weighting was disclosed in the solicitation notice.

This opportunity carries no set-aside designation and is open to all eligible vendors under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a 1,000-employee small business size standard. The contract type is Commercial Item-Firm Fixed Price with Net 30 payment terms, though no specific award value or budget range is disclosed. The contractor must provide a complete turn-key solution including newly manufactured equipment, all necessary supplies and accessories, installation with labor and shipping, on-site training for two users, and a one-year warranty with technical support, with all delivery, installation, and training to be completed within 90 calendar days from award. Performance of work will take place in Irvine, California at the FDA's Medical Products Laboratory, with shipment and installation required at that location.