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75F40126Q00406
Response Deadline
Sep 22, 2026, 7:00 PM(EDT)5 days
Eligibility
Contract Type
Combined Synopsis/Solicitation
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:
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• The FTIR system shall include the following salient requirements:
• Hardware and Connectivity shall include the following salient requirements:
• Warranty:
• Delivery, Installation and Service
• Training:
Trade and Service Specs
• 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. Ten-year warranty on source, laser, and interferometer. 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.
Deliverables or Delivery Schedule
Deliverable
Quantity
Due Date
FTIR (Fourier Transform Infrared Spectrometer) with Controller Software - 1
Within 6-8 weeks after date of award
Installation and Operation Qualification documentation - 1
Within 6-8 weeks after date of award
Familiarization Training - 3-5 users
Within 6-8 weeks after date of award
Instrument and Software User Manuals - 1
Within 6-8 weeks after date of award
Place of Performance
Food and Drug Administration
San Juan Medical Products Laboratory
466 Fernandez Juncos Ave,
San Juan, PR 00901-3223
POCs: To be identified at time of award.
Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made on the next business day. Delivery must be inside the facility.
Period of Performance
The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than 6-8 weeks after date of award.
Hours of Operation
The contractor is responsible for conducting business, between the hours of 8:00 AM – 4:00 PM Monday through Friday except Federal Holidays or when the Government facility is closed due to local or nation emergencies, administrative closings, increment weather, or similar Government directed facility closings. The contractor will not be expected to provide services on the following days:
New Year’s Day Labor Day
Martin Luther King Jr’s Birthday (Observance Day) Columbus Day
President’s Day Veteran’s Day
Memorial Day Thanksgiving Day
Juneteenth Christmas Day
Independence Day
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
FDA OFFICE OF ACQ GRANT SVCS
FDA OFFICE OF ACQ GRANT SVCS
11601 Landsdown St
Floor 13
Rockville, MD, 20852
NAICS
Analytical Laboratory Instrument Manufacturing
PSC
LABORATORY EQUIPMENT AND SUPPLIES
Set-Aside
No Set aside used