Thermo Scientific Exploris 120 Orbitrap Mass Spectrometers

The U.S. Food and Drug Administration (FDA), specifically the Office of Acquisitions and Grants Services (OAGS) on behalf of the Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ), is seeking sources for two Thermo Scientific Exploris 120 Orbitrap Mass Spectrometers and an Ultra-High Performance Liquid Chromatograph (UHPLC) system. This sources sought announcement aims to identify small businesses capable of providing these specialized scientific instruments under NAICS Code 334516 with a small business size standard of 1000 employees. The technical requirements include specific capabilities such as binary high pressure mixing pumps with a 0.1-5000 uL/min flow rate range, a temperature-controlled autosampler and column oven, a mass range of 40-300 m/z, and mass analyzer resolution up to 120,000 at 200 m/z. Interested small businesses must submit detailed company information demonstrating their ability to meet minimum performance requirements by January 28, 2025, at 10:00 AM ET via email to Erika.crawford@fda.hhs.gov. The evaluation will focus on the vendor's capability to provide the precise scientific equipment needed for testing and researching nitrosamine impurities in drug products and substances.

The procurement is currently not set aside for any specific business category, but the FDA may designate it as a small business set-aside if two or more capable sources are identified. The contract includes a comprehensive package with a one-year warranty and an optional one-year post-warranty maintenance period running from 10/18/2026 to 10/17/2027. Delivery of the equipment is required within 90 days after contract award, with installation scheduled at the FDA facility in Saint Louis, Missouri. While specific award values are not disclosed in the pre-solicitation notice, the procurement involves high-precision scientific instrumentation that likely represents a significant investment for the agency. The solicitation signals the FDA's ongoing commitment to maintaining advanced research capabilities, particularly in pharmaceutical quality control and impurity detection, through the acquisition of state-of-the-art analytical laboratory equipment.