RFQ 75F40126Q00091 Dual Dissolution
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00091
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- San Juan, Puerto Rico 00901, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA's San Juan Medical Products Laboratory is seeking quotations for a bathless dual dissolution system with an integrated autosampler and controller software to replace an obsolete analytical instrument. The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services issued this RFQ (75F40126Q00091) to procure new equipment that will maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards for analyzing medical product samples. The procurement requires two 115V bathless dissolution instruments with six spindle drives each, precision syringe pump autosamplers with less than 5 mL internal volume, a Windows 11 PC workstation with control software, and comprehensive installation and qualification services. Award will be based on a 50/50 weighting of Technical and Price evaluation factors, with award intended without discussions. Quotations must be submitted in two volumes by the deadline specified in SAM.gov, with questions due by May 5, 2026, at noon EST, and the overall response deadline of May 8, 2026.
This solicitation includes no set-aside designation and does not identify any incumbent contractors. The contract value has not been disclosed in the solicitation documents. The procurement involves delivery and installation within 6-8 weeks of contract award, followed by a three-year limited warranty period that may extend longer if the original equipment manufacturer's warranty extends beyond three years. The system must include twelve serialized wireless RTD shaft assemblies, twelve serialized paddle blades, twelve 1L amber glass vessels with certificates, comprehensive autosampler filter systems with supporting racks, and factory-certified installation with Hardware and Software IQ/OQ documentation. Performance of work will take place at the San Juan Medical Products Laboratory located at Calle Recinto Sur, San Juan, 00901, Puerto Rico, with onsite training required for three to five users and OEM-trained or certified engineers mandated for all installation and warranty services.
Notice text
The FDA San Juan Medical Products Laboratory (SJNLMP) requires the replacement of its obsolete dissolution bath systems used for routine sample analysis. The replacement system must maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards for analytical equipment under existing accreditation.
The laboratory analyzes medical product samples using established protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program (DOD SLEP), and the Federal Contract Compliance (FCC) program. To maintain modern analytical capabilities, SJNLMP requires a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components, as the previous system has been discontinued by the manufacturer.
Files
| File | Type | Posted |
|---|---|---|
| Attachment 2 - Pricing Sheet.xlsx | XLSX spreadsheet | |
| RFQ 75F40126Q00091 Dual Dissolution.pdf | ||
| Attachment 1 - SOW.pdf |
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