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

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING A RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is issuing this sources sought announcement on behalf of the Office of Pharmaceutical Quality Research – St. Louis (OPQR – St. Louis) to:

a) Identify small business vendors capable of providing the Thermo Scientific Auto Trace 280 SPE System or an equivalent system, and

b) Determine the availability and capability of potential small business sources.

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

Small Business Size Standard: 1,000 employees

Background

The OPQR – St. Louis supports the Office of Pharmaceutical Quality (OPQ) Nitrosamine Taskforce by screening for nitrosamine contaminants in drug products. To enhance the accuracy and reproducibility of sample pre-concentration for simple nitrosamines (e.g., NDBA, NDMA, NMOR, NDEA), an automated solid phase extraction (SPE) system is required. Manual pre-concentration is labor-intensive and susceptible to analyst error. An automated SPE system will streamline this process, reduce variability, and improve reliability.

Objective

To acquire a Thermo Scientific Auto Trace 280 SPE System (Part #071385) or equivalent, capable of automating sample pre-concentration for nitrosamine analysis in IV drug products, minimizing analyst variability and maximizing reproducibility.

Scope of Requirement

The instrument must meet the following technical requirements:

- Automatically condition, rinse, and elute SPE cartridges using at least five solvent options
- Provide positive pressure loading and elution for flow rate control
- Simultaneously load up to six aqueous samples (20 mL to 4 L)
- Segregate aqueous and solvent waste into separate waste lines
- Accommodate 1, 3, or 6 mL SPE cartridges or 47 mm SPE disks
- Integrated venting of solvent vapors
- Use non-fluoropolymer-based tubing and components to minimize contamination
- Include vendor-provided IQ/OQ services
- Include on-site instrument training
- Include technical support, preventative maintenance, and repair services
- Be a newly manufactured unit (not refurbished or previously used)
- Include a 12-month standard warranty with service agreement options

Deliverables

- Delivery, installation, and qualification of the instrument at:
  CDER/OPQ/OPQR – St. Louis 645 S. Newstead Ave. Saint Louis, MO 63110
- IQ/OQ within 90 days of award
- Training for 3–4 scientists within 60 days of IQ/OQ
- One-year warranty and optional service agreement for preventative maintenance
- Unlimited lifetime technical support (phone and internet)
- Reporting of installation and qualification
- Full acceptance upon completion of IQ/OQ and training

Requested Information from Vendors

Interested small business vendors are invited to submit a capability statement that includes the following:
- Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI).

- Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: Thermo Scientific Auto Trace 280 SPE System (Part #071385) or equivalent.

- What is your company size? If small, what is your socio-economic status?

- Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.

- Domestic manufacturing status.

- Technical specifications for the proposed solution.

Disclaimer and Important Notes

This is not a Request for Proposal (RFP) and does not commit the Government to award a contract. Responses will be used solely for market research. The FDA will not provide feedback or evaluations of submitted capabilities. Proprietary information should not be submitted.

Submission Instructions

Responses are due by 1:00 PM Eastern Time on August 20, 2025, and shall be submitted via email to:

Iris Johnson
Contract Specialist
Email: Iris.Johnson1@fda.hhs.gov
Subject: Notice Number: SSN_CDER-2025-129732 – Auto Trace 280 SPE System