Rapid sterility testing system (Milliflex Rapid 2. 0)

The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services is seeking to procure a Milliflex Rapid 2.0 sterility testing system for the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research. The procurement requires rapid microbial limit detection equipment capable of confirming bioburden contamination using membrane filtration with ATP detection technology to enhance CDER's testing capabilities for purified bulk drug substances and final formulated drug products. The system must include an autospray station and detection tower that are fully compatible with CDER's existing second-generation Milliflex Oasis filtration pump and filter membranes, and will support research into the robustness of rapid and alternative microbial detection methods used by industry. The solicitation operates under a firm-fixed-price contract structure with full and open competition. The deadline for submitting questions is June 24, 2025, at 12:00 PM Eastern Time, while the response deadline is June 27, 2025, with delivery and installation required within 45 days of award.

This procurement does not utilize any set-aside designations and falls under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees. The comprehensive system includes 17 line items encompassing the Milliflex Rapid 2.0 Detection System kit, filtration equipment, power supplies, reagent kits, membrane filtration cups, and associated training and installation services, though specific pricing values are not disclosed in the available documentation. The contract requires on-site training and services to be completed within one year post-installation, with the primary place of performance located in Silver Spring, Maryland. The solicitation is classified under PSC code 6640 for Laboratory Equipment and Supplies, and the procurement timeline allows for an 11-day response period from the posting date of June 16, 2025. No incumbent contractors or previous service providers are identified in the solicitation materials, indicating this may be a new capability acquisition for the agency.