Distek Model 2500 Dissolution System

The Food and Drug Administration seeks to procure one Distek Model 2500 Dissolution System for its New York Medical Products Laboratory, with quotes due August 6, 2026. This is a Firm Fixed-Price procurement with no small business set-aside.

Place of performance is Jamaica, New York. The system must be newly manufactured, 115V, and accommodate up to 8 vessels ranging from 100 mL to 2L, with RPM control from 25–300 RPM (1 RPM accuracy up to 100 RPM, 1% accuracy above 100 RPM) and vessel temperature control from ambient to 55°C (0.25°C accuracy). The system must include 6 spindle drives, water bath, touch screen interface, TCS-0500 Hideaway Thermocirculator, 21 CFR Part 11 compliant software, and interface ports (USB, Ethernet, RS-232, RS-485). All components must be serialized and certified, including 6 wireless RTD shaft assemblies, paddle blades, baskets, and 1L glass dissolution vessels. Delivery is FOB destination with inside facility delivery required within 6–8 weeks of award. The contractor must provide product training and familiarization for 5 users, a minimum one-year OEM warranty covering all non-consumable items with unlimited on-site service visits, replacement parts, and engineer labor and travel costs beginning upon formal government acceptance. Installation and qualification services include Installation Qualification, Mechanical Qualification per ASTM E2503 and USP Toolkit Procedure, and Performance Verification Test per USP General Chapter. Payment is Net 30 following government acceptance. Quotes must be submitted by email to Tiffany Gates at tiffany.gates@fda.hhs.gov. Award goes to the lowest-priced technically acceptable and responsible offeror. NAICS code is 334516, Analytical Laboratory Instrument Manufacturing; PSC is 6640, Laboratory Equipment and Supplies.