**PLEASE SEE ATTACHED Solicitation Number: FDA-24-1277356 FOR ALL REQUIREMENTS** 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 a variety of drug samples. The San Juan Laboratory needs to update the existing 16-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 up to 10 years and comes with newer software and instrument controller. OBJECTIVE To obtain a fully functional modern Fourier Transform Infrared Spectrometer (FTIR) with improved analytical capabilities to replace a 16-year-old FTIR system. One FTIR system to replace an older FTIR system. REQUIREMENTS The Contractor shall provide the following system requirements: • The Fourier Transform Infrared Spectrometer (FTIR) shall comply with the following quality requirements: o ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html o ISO 9001:2008 https://www.iso.org/standard/46486.html o 21 CFR Part 11 Compliance https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm o USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin o Instrument controller firmware, drivers, and updates shall be compatible with the current laboratory domain system. Optical System shall include: o Integrated touch panel. o Sealed and desiccated optical unit. o Deuterated Lanthanum α Alanine doped TriGlycine Sulphate (DLaTGS) detector. o Detector with KBr Windows. o Interferometer with KBr/Ge coated Beam Splitter and dynamic alignment. o Diamond turned, alignment free optics. o Spectral range: 7,800-350 cm-1 o Spectral resolution of 0.25 cm-1 or better. o Signal to noise (S/N) of 50,000:1 (peak to peak) o Rapid Scan 40 scans/s o Purge Kit o Rechargeable desiccant cartridges. o Humidity Indicator o Self-compensating o Self-performance verification. o Performance Verification Kit Validation wheel with serialized NIST traceable polystyrene film, and NG-11 Schott glass. o Spectrometer PC USB 2.0 Interface • iTX with XR Diamond Crystal Plate shall include: o Spectral Range 7800 – 350 cm-1 o Traceable polystyrene ATR standard • Computer Workstation shall include: o Windows 10 OS o 32 GB RAM o 1 TB SSD Hard Drive o Keyboard and Mouse o Monitor 27” • Instrument Controller Software shall include: o Qualification Software o Desktop Instrument Controller Software • Spectrometer Compatible with iS-5 Microscope. • 10-year warranty on source, laser, and interferometer • Shipping to Puerto Rico • Installation and instrument configuration • Installation and Operational Qualification • Familiarization Training for 3-5 users The Contractor shall ensure the following: • Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. • The Contractor shall provide a minimum of a one-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. • Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. • The supplier shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided, such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. • The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols. • Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative. ORDER ADMINISTRATION PERIOD OF PERFORMANCE The anticipated dates are: 08/25/2024 – 08/24/2025 The respirator shall be delivered NLT 45 days post award. Unless otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather. Government Holidays: January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) PLACE OF PERFORMANCE US, Food and Drug Administration San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223 POC: Will be identified at time of award. GOVERNMENT POINTS OF CONTACT Contract Specialist Elena Tatarov U.S. Food and Drug Administration Office of Acquisitions and Grants Services Email:
[email protected] Contracting Officer’s Representative (COR) TBD – provided at time of award CONTRACTING OFFICER AUTHORITY The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds. The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.