FDA Automated vitrification instrument system

Background
The U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR), Division of Viral Products (DVP), is seeking a fully automated laboratory vitrification system. This system is essential for preparing cryo-electron microscopy (cryo-EM) specimens by rapidly freezing biological samples in their native, hydrated state, which is critical for vaccine research and regulatory decision-making.

Work Details
The contract requires the delivery of one fully automated laboratory vitrification system with dual-sided blotting capability. The system must meet the following technical specifications:

- Stand-alone, newly manufactured, not used or refurbished.
- Fully automated specimen preparation with programmable parameters including blotting time, blot force, wait time, and drain time.
- Temperature control range from +4°C to +60°C; humidity control range from 0% to 100% relative humidity with real-time monitoring.
- Compatible with standard 3mm cryo-EM grids; includes tweezers/grid handling system.
- Dual-sided blotting capability with adjustable blot force and time; includes filter paper advancement system.
- Liquid ethane capability with temperature monitoring and control; user safety features for handling cryogenic liquids.
- Touchscreen interface with programmable protocols and real-time process monitoring.
- Enclosed working chamber with gas detection and ventilation compatibility; emergency stop functionality.
- Seamless integration with existing Tundra Cryo-TEM equipment.
- Minimum one-year full manufacturer’s warranty included.

Delivery is FOB Destination to the FDA Center located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Place of Performance
U.S. FDA Center for Biologics Evaluation and Research (CBER), OVRR-DVP, Bldg. 52/72, Room 1132, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002

Bidder Requirements
This solicitation is a Small Business Set Aside - Total (SBA). Bidders must provide proof of being an authorized distributor or OEM for the equipment offered. Compliance with Section 508 accessibility standards is required, including submission of an Accessibility Conformance Report (ACR) for any items not compliant.