THERMO SCIENTIFIC AUTO TRACE 280 SOLID PHASE EXTRACTION (SPE) SYSTEM OR EQUIVALENT

AI Summary

The U.S. Food and Drug Administration requires the acquisition of a Thermo Scientific AutoTrace 280 Solid Phase Extraction System or equivalent. This includes delivery, installation, qualification, training, and warranty to support nitrosamine testing in IV drug products. Interested vendors should review the Combined Synopsis/Solicitation for details and submit questions by September 2, 2025, and quotations by September 4, 2025.

Contract details

Solicitation No.: 75F40125Q00404
Notice Type: Combined Synopsis/Solicitation
Set-Aside: SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15)
Posted Date: August 29, 2025
Response Deadline: September 4, 2025
NAICS Code: 334516 AI guide
PSC / Class Code: 6640
Issuing Office: FDA OFFICE OF ACQ GRANT SVCS
Sub-Agency: FOOD AND DRUG ADMINISTRATION
Agency: DEPARTMENT OF HEALTH AND HUMAN SERVICES
Primary Contact: Iris Johnson
City: ROCKVILLE
State: MD
ZIP Code: 20857
AI Product/Service: product

Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research – St. Louis (OPQR–St. Louis), requires the acquisition of a Thermo Scientific AutoTrace 280 Solid Phase Extraction (SPE) System or equivalent, including delivery, installation, qualification (IQ/OQ), training, and warranty. The system will support the FDA’s nitrosamine testing program by automating pre-concentration of contaminants such as NDBA, NDMA, NMOR, and NDEA from large-volume intravenous (IV) drug products to ensure reproducible and accurate results.

Interested vendors are advised to carefully read the attached Combined Synopsis/Solicitation (CSS 75F40125Q00404) in its entirety for full details, submission instructions, and applicable provisions/clauses.

Questions are due no later than September 2, 2025, at 10:30 AM Eastern Time (ET).
Quotations are due no later than September 4, 2025, at 4:00 PM Eastern Time (ET).

Key dates

August 29, 2025Posted Date
September 4, 2025Proposals / Responses Due

AI search tags

laboratory equipment solid phase extraction pharmaceutical testing contaminant analysis

Frequently asked questions

THERMO SCIENTIFIC AUTO TRACE 280 SOLID PHASE EXTRACTION (SPE) SYSTEM OR EQUIVALENT is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.