Thermo Scientific Auto Trace 280 Solid Phase Extraction (SPE) System or Equivalent

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Office of Pharmaceutical Quality Research in St. Louis, is seeking to acquire a Thermo Scientific AutoTrace 280 Solid Phase Extraction System or equivalent equipment. The procurement includes delivery, installation, qualification testing (IQ/OQ), training, and warranty services to support the FDA's nitrosamine testing program. The system will automate pre-concentration of contaminants including NDBA, NDMA, NMOR, and NDEA from large-volume intravenous drug products to ensure reproducible and accurate analytical results. Interested vendors must submit questions by September 2, 2025, at 10:30 AM Eastern Time, with final quotations due September 4, 2025, at 4:00 PM Eastern Time. The complete solicitation details, submission instructions, and evaluation criteria are contained in the Combined Synopsis/Solicitation document CSS 75F40125Q00404.

This opportunity is designated as a Woman-Owned Small Business set-aside under federal contracting requirements. The solicitation falls under NAICS code 334516 for Analytical Laboratory Instrument Manufacturing and PSC category 6640 for Laboratory Equipment and Supplies. The equipment will be utilized at the FDA's St. Louis facility to support pharmaceutical quality research operations. The procurement timeline indicates an expedited acquisition schedule with only six days between the posting date of August 29, 2025, and the quotation deadline of September 4, 2025. No incumbent contractor information, specific award values, or quantity details are disclosed in the publicly available solicitation notice.