Fourier Transform Infrared Spectrophotometer (FTIR)

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, delivery, and travel costs.
• Inside delivery, set up, installation, and clean-up of the area at the place of performance is required.
• The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
• Standard kits for operational qualification and performance verification (OQ/PV) shall be included.
• Installation of hardware & software shall be conducted by factory-certified service personnel.
• The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used as evaluation criteria for award. The following shall be demonstrated at the time of installation:

• The contractor shall demonstrate that all modules start up properly, are correctly installed and connected.

• Shall include Hardware IQ/OQ with Performance Verification.
• Shall include Software IQ/OQ and testing of basic functional specifications and Chapter 21 CFR part 11.
• The vendor shall provide IQ/OQ electronic documentation of Software and Hardware.
• The vendor shall include a minimum of one preventative maintenance visit for the KFT to ensure the instruments are functioning at peak performance.
• The vendor shall include shipping to Puerto Rico.

•           Training:

• Onsite familiarization training for 3-5 users shall include basic system operation and routine maintenance.

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