Description
The FDA San Juan Medical Products Laboratory 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.
• The replacement system must be a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components.
• The system must comply with the following standards: ISO/IEC 17025:2017, ISO 9001:2008, 21 CFR Part 11, and USP.
• The system must include a dual bathless 115V dissolution instrument, autosampler, and controller software.
• The contractor must provide onsite installation, training, and documentation.
• The contractor must provide a minimum three-year limited warranty beginning upon formal Government acceptance covering parts and labor.