SAM #75F40126SSN134450

FDA Seeks Automated Vitrification System for Cryo-EM Specimen Preparation

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR), Division of Viral Products (DVP), is seeking information from vendors for a fully automated laboratory vitrification system for cryo-EM specimen preparation. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Biologics Evaluation and Research (CBER) - Office of Vaccine Research and Review (OVRR), Division of Viral Products (DVP) - Products/Services Requested: - Stand-alone, fully automated vitrification system for rapid freezing of biological samples for cryo-electron microscopy (cryo-EM) - Key technical requirements: - Automated vitrification with programmable parameters (blotting time, blot force, wait time, drain time) - Environmental control (temperature: +4°C to +60°C; humidity: 0-100% RH) - Compatibility with standard 3mm cryo-EM grids - Dual-sided blotting with filter paper advancement - Liquid ethane cryogen system with safety features - Touchscreen user interface - Enclosed working chamber with gas detection and emergency stop - Integration with existing Tundra Cryo-TEM equipment - Minimum one-year full manufacturer's warranty - No specific OEMs or vendors are named in the solicitation - The FDA is requesting capability statements from both small and large businesses - No part numbers or purchase quantities are specified - Unique/Notable Requirements: - System must integrate with existing Tundra Cryo-TEM - Emphasis on automation, safety, and environmental control - Full manufacturer's warranty required

Description

This Sources Sought Notice is germane to an FDA requirement for a stand-alone benchtop vitrification instrument system.  Please see the attached PDF file titled FDA 75F40126SSN134450.

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