The US FDA, Office of the Chief Scientist (OCS), San Juan Medical Products Laboratory (SJNLMP) is seeking a Karl Fischer Titrator (KFT) or equivalent system to replace an older KFT system. The instrument must meet or exceed the requirements outlined in the solicitation, including compliance with ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11. The system must be a modular design, controlled by the latest Instrument Controller Software, and include a Dynamic Dosing Unit, titration stand with magnetic stirrer and built-in pump, and other specified components. The contractor shall provide all labor, travel, and tools to install the equipment, and provide on-site operator training/familiarization for 3-5 users.
Some key points to consider:
• The system must meet or exceed the requirements outlined in the solicitation.
• The system must be a modular design and include a Dynamic Dosing Unit.
• The contractor shall provide all labor, travel, and tools to install the equipment.
• The contractor shall provide on-site operator training/familiarization for 3-5 users.
• The system must be warranted for not less than one (1) year from FDA acceptance of the system(s).
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