SAM #FDA-OC-2026-132805

FDA Procurement of Four Advanced Mass Spectrometer Systems with Installation and Training

The Food and Drug Administration (FDA) Office of the Chief Scientist is seeking to procure four advanced mass spectrometer systems for multiple laboratory locations. - Government Buyer: - Food and Drug Administration (FDA), Office of the Chief Scientist - Key contacts: Sephora Calderon (CO), Neal Alcalay (COR) - Products Requested: - 1 high resolution quadrupole-ion trap mass spectrometer with UHPLC for Irvine - Orbitrap Exploris 480 or equivalent; Vanquish Flex Binary UHPLC or equivalent - Includes computer workstation, uninterruptible power supply, nitrogen generator - 1 Ultra-High-Field Triple Quadrupole Detector with UHPLC and diode array detector for San Juan - System compliant with ISO/IEC 17025-2017, ISO 9001:2008, 21 CFR 11 - Includes computer workstation, uninterruptible power supply, nitrogen generator - 2 hybrid quadrupole/linear ion trap LC-MS/MS systems for the National Forensic Chemistry Center - Atmospheric pressure ionization source, linear ion trap analyzers, specified scan ranges - Includes 2 computer workstations - 4 compatible computer workstations/controllers (Windows 10/11, high specs) - 3 uninterruptible power supplies and power distribution units - 3 nitrogen generators (up to 35 L/min, 116 psi, 99.5% purity) - Services Requested: - Installation by factory certified engineers, including verification testing, calibration, IQ/OQ certification, and performance verification - Operator-level training for 5 users per system, including manuals and consumables - Preventative maintenance visit during warranty period - Unique/Notable Requirements: - All systems must meet specific performance, software, and regulatory standards (ISO/IEC 17025-2017, ISO 9001:2008, 21 CFR 11) - Delivery and installation required within 90 days of award - 12-month warranty period with preventative maintenance - Training and documentation deliverables due within two weeks after acceptance - OEMs Highlighted: - Thermo Fisher Scientific (Orbitrap Exploris 480, Vanquish Flex Binary UHPLC) - Other equivalent OEMs may be considered for all systems - Delivery Locations: - Irvine, CA; San Juan, PR; National Forensic Chemistry Center

Description

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