Karl Fischer Titrator (KFT) or equivalent system

The FDA's Office of the Chief Scientist, San Juan Medical Products Laboratory is procuring an OMNIS Karl Fischer Titrator (KFT) or equivalent system to replace aging equipment used for analyzing medical product samples in accordance with USP protocols, internal FDA programs, DOD SLEP, and FCC program requirements. The solicitation is a full and open competitive procurement under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees. The required system must feature a modular design with the latest Instrument Controller Software, Dynamic Dosing Unit, titration stand with magnetic stirrer and integrated pump, dual burettes (10 mL and 20 mL high-resolution), four MSB connectors, USB/RS-232 converter, and integration capability with existing Mettler Toledo balance equipment. The system must comply with ISO/IEC 17025-2017, ISO 9001:2008, 21 CFR Part 11, and USP cGMP/cGLP standards, with pricing evaluated as a firm fixed-price commercial product inclusive of all labor, travel, shipping, and installation costs. The proposal deadline is April 9, 2026 at 1:30 PM Central Time, with all price quotes required to remain firm through September 30, 2026.

No set-aside designations apply to this procurement, and no incumbent contractor is identified in the solicitation documents. Delivery, installation, operator training for three to five users, Installation and Operational Qualifications (IQ/OQ), and a one-year warranty including preventative maintenance must be completed within 90 days of contract award at the San Juan Medical Products Laboratory in Puerto Rico. Payment will be made on a Net 30 day basis following government acceptance of invoices submitted through the Department of Treasury's Invoice Processing Platform (IPP). The solicitation does not specify an award value or budget range, though offerors are instructed to provide detailed and itemized pricing. Respondents must include their Unique Entity ID (UEI) with their submission to be considered for award.