Fourier Transform Infrared Spectrophotometer (FTIR)

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Statement of Work (SOW) Fourier Transform Infrared Spectrometer (FTIR) for the San Juan Medical Products Laboratory Background The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) needs to replace an existing Fourier Transform Infrared Spectrometer (FTIR) system used for routine sample identification analysis with a new Fourier Transform Infrared Spectrometer (FTIR System. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by USP, internal FDA, DOD SLEP, and the FCC program. As a Medical Product Specialty Laboratory, the laboratory uses FTIR technology to analyze and provide specific identification to a variety of drug samples. The San Juan Laboratory needs to update the existing 17-year-old FTIR to a new system with modern capabilities, software, and instrument components. The older FTIR system is no longer supported by the manufacturer, is out of service and in need of repairs, and is no longer functioning as intended. In addition, the hardware shows internal system rust and lens fogging, increasing maintenance cost, posing analytical failures and instrument malfunction. The newer Fourier Transform Infrared Spectrometer (FTIR) includes part warranties for up to 10 years and comes with newer software and instrument controller. Objectives To obtain a fully functional modern Fourier Transform Infrared Spectrometer (FTIR) with improved analytical capabilities to replace a 17-year-old FTIR system. Scope The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). One FTIR system to replace an older FTIR system. Requirements All the following system requirements are minimum requirements: • The Fourier Transform Infrared Spectrometer (FTIR) shall comply with the following quality requirements: ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html ISO 9001:2008 https://www.iso.org/standard/46486.html 21 CFR Part 11 Compliance https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin Instrument controller firmware, drivers, and updates must be compatible with the current laboratory domain system. • The FTIR system shall include the following salient requirements: Optical System shall include the following specifications: Spectral range: 8,000-350 cm-1 Spectral resolution: Better than 0.45 cm-1. Signal-to-Noise Ratio: 40,000:1. Wavenumber Precision: 0.001 cm?¹ at 2,000 cm?¹. Sealed and desiccated optical unit. Detector: Thermoelectrically cooled (TEC) DTGS. Interferometer with KBr/Ge mid-infrared beamsplitter. Source: Single-point source with 10-year warranty. ATR with XR Diamond Crystal Plate shall include the following specifications: Spectral Range 7800 – 350 cm-1 Traceable polystyrene ATR standard The system shall include a Desiccant Replacement Kit. The system shall include Purge Kit. • Hardware and Connectivity shall include the following salient requirements: Integrated touchscreen Integrated LightBar status. Ethernet connection Monitor 22” Wireless Keyboard and Mouse Windows 10 The system shall include the current Instrument Controller Software with: Data Acquisition & Analysis Spectral Processing Library Instrument License Current Instrument Firmware • Warranty: The entire system shall be warrantied for parts and labor for a minimum of 1-year limited warranty from date of formal government acceptance. The Diamond ATR shall be warrantied for 5 years. The source, laser, and interferometer shall be warrantied for 10-years. • Delivery, Installation and Service Onsite installation of the entire system shall be included and inclusive of labor,…

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