Mettler Toledo HX204 Halogen Moisture Analyzer (or equivalent)

The U.S. Food and Drug Administration's Office of Acquisition and Grant Services is seeking to procure one newly manufactured Mettler Toledo HX204 Halogen Moisture Analyzer or equivalent instrument for the San Juan Medical Products Laboratory. The system will replace current manual testing methods for loss on drying analysis of medical product samples and must meet stringent quality standards including ISO/IEC 17025-2017, ISO 9001:2008, 21 CFR Part 11 compliance, and USP cGMP/cGLP requirements. Key technical specifications include moisture readability of at least 0.001%, maximum capacity of 200 grams, programmable user roles, real-time drying curves, storage for 300 methods and 3,000 results, control charts, and automated export functionality with current Instrument Controller Software featuring SQL database capability. Offerors must demonstrate compliance through detailed technical specifications, descriptive materials, and scientific literature, with "equal" product quotes requiring narrative descriptions of how offerings meet each salient characteristic. The deadline for submission of quotes is April 15, 2026, at 1:30 PM Central Time, with quotes to be submitted electronically to Suzanne Martella at suzanne.martella@fda.hhs.gov.

This is a full and open, firm fixed-price commercial items acquisition with no set-aside designations, available to businesses of any size under NAICS code 334516. The contract requires a complete turn-key solution including factory-certified installation, onsite Installation Qualification, Operational Qualification, and Performance Verification testing, as well as onsite operator training for 3-5 users and one-year warranty with technical support. All deliverables, installation, qualification tests, and training must be completed within 90 days of contract award. Quoted prices must be inclusive of shipping, installation, and all associated services, with payment terms of Net 30 days after government acceptance. The place of performance and delivery is the Food and Drug Administration San Juan Medical Products Laboratory located at 466 Fernandez Juncos Ave, San Juan, PR 00901-3223. The Buy American Act applies to this procurement, requiring offerors to certify product origin and domestic content, and all invoices must be submitted electronically through the Department of Treasury's Invoice Processing Platform.