Fourier Transform Infrared Spectrophotometer (FTIR)
The FDA’s San Juan Medical Products Laboratory needs to replace a 17-year-old Fourier Transform Infrared Spectrometer (FTIR) with a modern system that maintains cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11 compliance for medical product sample identification. The contractor must supply one FTIR system meeting specified optical, ATR, hardware, software, and connectivity requirements, including a TEC DTGS detector, KBr/Ge beamsplitter, integrated touchscreen, Windows 10 controller, and current instrument software/firmware. Warranty requirements include a minimum 1-year parts/labor warranty, 5-year diamond ATR warranty, and 10-year source, laser, and interferometer warranty, plus onsite installation, IQ/OQ documentation, performance verification, preventive maintenance, and shipping to Puerto Rico. Onsite familiarization training for 3–5 users and user manuals are required, with deliverables due within 6–8 weeks after award and instrument delivery also required no later than 6–8 weeks after award. Performance will occur at the FDA San Juan Medical Products Laboratory, 466 Fernandez Juncos Ave, San Juan, PR 00901-3223, and the period of performance begins at contract award execution and continues for one year, or longer depending on the OEM warranty period, from formal government acceptance.