Karl Fischer Titrator (KFT) or equivalent system

The Food and Drug Administration's Office of Acquisition and Grant Services, on behalf of the San Juan Medical Products Laboratory in Puerto Rico, is seeking a Karl Fischer Titrator (KFT) or equivalent system to replace an existing analytical instrument. This Sources Sought Notice targets small businesses under NAICS 334516 (Analytical Laboratory Instrument Manufacturing), though all interested vendors are encouraged to respond, particularly those offering domestic products. The required system must be modular, newly manufactured, and feature specific technical components including a dynamic dosing unit, titration stand with magnetic stirrer and built-in pump, high-resolution burettes with multiple connectors, and integration with an existing Mettler Toledo balance. The complete turn-key solution must include a Windows 11 workstation with Intel I7 processor, minimum 16 GB RAM, and 256 GB SSD, along with comprehensive software and compliance with multiple quality standards including ISO/IEC 17025-2017, ISO 9001:2008, 21 CFR Part 11, and USP/cGMP/cGLP requirements. All responses must be submitted by email to suzanne.martella@fda.hhs.gov by 3:00 pm Central Time on February 4, 2026, referencing the notice number 75F40126SSN132651.

This is a market survey for information only and does not constitute a binding solicitation; therefore, no contract will be awarded from this notice and respondents will not be reimbursed for response costs. No specific incumbent contractor or award value has been identified in the notice. Vendors must provide delivery, installation, training, and all associated supplies within 90 days of contract award, including factory-certified installation, on-site Installation and Operational Qualifications, training for 3-5 users, comprehensive manuals, and a minimum one-year warranty with phone and email support. Responses must include company information, past performance data from the past three years, detailed technical specifications demonstrating compliance with all requirements, descriptive literature, pricing information, GSA Schedule or Best in Class contract information if applicable, country of manufacture details relevant to Buy American requirements, and identification of subcontracting opportunities for large businesses if applicable.