Karl Fischer Titrator (KFT) or equivalent system
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Office of the Chief Scientist (OCS), San Juan Medical Products Laboratory (SJNLMP) requires an OMNIS Karl Fischer Titrator (KFT) or equivalent system. This procurement aims to replace an older KFT system used for analyzing medical product samples according to established protocols. This is a Combined Synopsis/Solicitation for a Firm Fixed-Price contract. Quotes are due April 9, 2026, at 1:30 PM Central Time.
Scope of Work
The required KFT system must be a newly manufactured unit with a modular design, controlled by the latest software and firmware. Key components include a Dynamic Dosing Unit, a titration stand with a magnetic stirrer and built-in pump for solvent management, a titration vessel, stirring bar, solvent and waste bottles, four MSB connectors, and 10 mL and 20 mL high-resolution burettes. It must also integrate with the existing laboratory balance using a USB/RS-232 Converter. The instrument must meet or exceed specific protocols from USP, internal FDA programs, DOD SLEP, and the FCC program.
Quality, Delivery & Warranty
The system must comply with ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11. The contractor is responsible for all hardware, software, labor, and travel for installation by factory-certified personnel. On-site Installation Qualification (IQ) and Operational Qualification (OQ) are mandatory, along with on-site operator training for 3-5 users. A minimum one-year warranty from FDA acceptance is required, covering on-site training, troubleshooting, replacement parts, system updates, labor, and travel, plus one year of phone and email technical support. Preventative maintenance is required approximately 11 months after purchase.
Contract & Timeline
- Contract Type: Firm Fixed-Price (Commercial Product)
- Period of Performance: Delivery, installation, qualification, and training within 90 days of contract award.
- Set-Aside: Full and Open Competition (NAICS 334516, Small Business Size Standard 1,000 employees)
- Response Due: April 9, 2026, 1:30 PM Central Time
- Published: April 3, 2026
- Prices Held Firm: Through September 30, 2026
Submission & Evaluation
Quotes must reference solicitation number 75F40126Q132651 and be submitted via email. A written solicitation will not be issued. Award will be made to the lowest priced technically acceptable responsible quoter. Technical acceptability will be determined by sufficient technical information demonstrating that quoted products meet or exceed all requirements.
Additional Notes
Offerors must monitor SAM.gov for updates and ensure electronic documents do not contain macros. Section 508 accessibility standards apply. Payment will be made via the Invoice Processing Platform (IPP).