RFQ 75F40126Q00091 Dual Dissolution 75F40126Q00091
Summary
AI-generated · Apr 21, 2026Replace obsolete dissolution bath systems with a bathless dual dissolution system that includes an integrated autosampler, PC workstation, controller software, and serialized instrument components, since the previous system has been discontinued by the manufacturer.
Must maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 for analytical equipment under existing accreditation. The system will support analytical work on medical product samples using protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program (DOD SLEP), and the Federal Contract Compliance (FCC) program.
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.
From Combined Synopsis/Solicitation posted on Apr 20, 2026Notice history
1Details
Award Information
Not yet awarded
Contacts
Phone
Agency
Place of Performance
USA