Statement_of_Work_HFP_2025_127075.pdf

Statement of Work

Title: Optical- Photothermal Infrared- Raman- Fluorescence (O-PTIR-R-FL) Microscope (Brand Name: mIRage-LS or Equal)

I. Purpose

The purpose of this statement is to purchase a microscope equipped with optical- photothermal infrared, Raman, and fluorescence (O-PTIR-R-FL) capabilities for the Office of Applied Laboratory Science (OLOAS), Office of Chemistry and Toxicology (OCT), Division of Analytical Chemistry (DAC), Spectroscopy and Mass Spectrometry Branch (SMSB) within the Human Foods Program (HFP) (brand name or equal).

II. Background

OLOAS/OCT/DAC/SMSB requires the purchase of a mIRage-LS O-PTIR-R-FL microscope, or equal for simultaneous Raman and IR imaging analysis and fluorescence of the same sample. The use of a mIRage-LS O-PTIR-R-FL microscope, or equal provides capabilities for the qualitative and quantitative analysis of micro- (1 µm - 5 mm) or nano- (1 nm - 1 µm) plastics, or other contaminants, in foods. Existing laboratory equipment does not have the capabilities to identify size, color, composition, and quantity of particles, which are critical for the analysis of microplastics. Vibrational microscopies, including Raman and IR, can quickly reveal the quantity and composition of microscopic plastic particles. While traditional Fourier transform-infrared spectroscopy (FT-IR) is advantageous for characterizing colorful samples and provides better signal-to-noise than Raman, Raman has higher spatial resolution than FT-IR, which allows for sampling of smaller particles. Spatial resolution of FT-IR can be maximized (10 µm) by use of attenuated total reflectance (ATR) crystals, but this sampling technique requires contact with the sample, potentially causing unacceptable damage or distortion. IR microscopies performed by directly detecting IR light, including FT-IR or laser direct infrared imaging (LDIR), will not satisfy this spatial resolution requirement due to the limitations imposed by the inherent diffraction limit of IR light. O-PTIR is a unique, non-contact technique which overcomes the spatial resolution limitations of traditional FT-IR or LDIR (10 µm) to measure sample features as small as Raman (500 nm) with high sensitivity. O-PTIR operates by detecting IR-induced changes in the photothermal properties of a sample using a visible probe beam that can achieve much higher spatial resolution than IR light. Additionally, simultaneous O-PTIR and Raman imaging gives complementary information on the same sample, a feat which is impractical to achieve in a reasonable timeframe by using two separate instruments to generate IR and Raman data from the exact same spot. This simultaneous analysis also offers more comprehensive identity confirmation of plastic particles or other analytes because of the information gained by recording both IR and Raman spectra. The flexibility of co-located O-PTIR and Raman allows the user to take advantage of the strengths of each of these techniques when necessary to tackle different challenging samples. The fluorescence imaging configuration of the instrument is also required, as opposed to relying on a white light image, to distinguish Nile red-stained plastics or autofluorescent plastics from other interfering particles, allowing for quicker screening and higher sampling throughput. The mIRage-LS O-PTIR-R-FL instrument, or equal will satisfy SMSB’s need for a sub-micron (smaller than 1 µm) optical photothermal infrared imaging system with Raman and fluorescence capabilities. This equipment will not only be necessary for analyzing micro- and nanoplastics, but it could also be utilized for a variety of other spectroscopic applications related to the safety of foods and food packaging.

III. Objectives

The objective of this requirement is to purchase a mIRage-LS O-PTIR-R-FL microscope, or equal, which is critical to supporting the agency’s mission in the development and validation of qualitative and quantitative methods to analyze nano- and micro-sized contaminants, such as microplastics, that may be present in foods and other products.

The major components of this acquisition plan are the following:

• mIRage-LS O-PTIR-R-FL microscope, or equal with 532 nm probe

Including:

o Base microscope system capable of O-PTIR measurements with sub-micron spatial resolution

Motorized x-y stage capable of O-PTIR imaging with sub-micron step size

• Imaging, line scanning, and single point data collection mode

Non-contact mid-infrared illumination (2990-2700 cm-1, 2300-2000 cm-1, and 1800-985 cm-1) by quantum cascade laser (QCL)

Co-located illumination by visible probe beam for detection of photothermal effects induced by IR illumination

O-PTIR signal from sub-micron sample features O-PTIR imaging capability Co-propagating/reflection configuration with top-down IR illumination Capability for future add-on of counter-propagating/transmission configuration with bottom-up IR illumination o Co-located, simultaneous O-PTIR and Raman measurements

O-PTIR and Raman signal with same, sub-micron spatial resolution Simultaneous O-PTIR and Raman imaging capabilities 532 nm Raman probe configuration Future support for an additional visible probe laser (785 nm) for dual Raman measurements o Co-located fluorescence imaging configuration o Incident light sources for bright field, O-PTIR, Raman, and fluorescence measurements

White light source with filter cubes for fluorescence excitation Triple range quantum cascade laser (QCL) 532 nm visible probe/Raman laser o Detector suited for ultra-low laser powers to minimize sample photo-degradation o Integrated computer-based data system including software for controlling the instrument, running measurements, acquiring data, data visualization, data processing and analysis, data exportation, database searching, etc.

o Spectral database for determining hit quality index, including relevant spectral libraries for polymers, foods, food contact materials, etc.

o Automated switching between instrument modes through software without manual movement of instrument components o A newly manufactured unit, not used or refurbished, or previously used for demonstration, meeting all the technical and hardware specifications specified under “Requirements” below o Shipping of all parts and equipment o Delivery and installation of instrument where HFP project officer will perform inspection and acceptance of system o Demonstration by vendor upon installation that the item shall meet all performance specifications by the manufacturer o At least three full days of on-site installation and training o Assistance with initial use and troubleshooting via technical support o System warranty for parts and labor for twelve (12) months from date of installation. Service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures

IV. Requirements

The Contractor shall provide a brand name or equal instrument that meets the following technical requirements:

Optical- Photothermal Infrared- Raman- Fluorescence (O-PTIR-R-FL) Microscope with 532 nm Probe

1. Microscope unit capable of co-located, simultaneous O-PTIR and Raman with sub-micron spatial resolution and co-located fluorescence, including:

a. Optical microscope

b. Four-position motorized objective turret

c. 10x visible long working distance objective (0.30 numerical aperture (NA), 16 mm working distance, refractive)

d. 40x visible/ IR Cassegrain objective (0.78 NA, 8.3 mm working distance, reflective)

e. Integrated 5 megapixel (MP) color camera for sample viewing

f. Motorized x-y stage

i. Range of 75 mm x 110 mm

ii. Minimum step size of 100 nm

iii. Fits standard 75 mm x 25 mm glass slides

iv. Accommodates samples as large as 60 mm in x-y without impacting stage travel distance capabilities

v. Fits samples with maximum thickness of 22 mm

g. Quantum cascade laser (QCL) for non-contact mid-IR illumination for O-PTIR

i. Chips covering ranges of 2990-2700 cm-1, 2300-2000 cm-1, and 1800-985 cm-1

ii. High spectral resolution (<1 cm-1)

iii. QCL liquid cooling system

h. 532 nm laser

i. Serves both as a probe beam for sub-micron O-PTIR and as a Raman excitation source

ii. Raman spectral range of 3800-200 cm-1

iii. Spectral resolution of 4 cm-1

i. Capability for an additional 785 nm laser and dual Raman configuration as a potential future add-on

j. Raman spectrometer and integration

i. 600 grooves/mm, 500 nm blaze grating

ii. Camera with 2000 x 256 pixels, each pixel = 15 µm

k. Detector for ultra-low laser power

l. Co-propagating/reflection configuration with top-down IR illumination

m. Ability to support future addition of counter-propagating/transmission configuration for bottom-up IR illumination

n. IR hyperspectral and O-PTIR imaging

o. Computer-based data system, electronics, and power supply

p. Optical table (3’ x 4’)

q. Instrument software package

r. Test and calibration samples

s. Integrated O-PTIR spectral database for chemical identification

t. System footprint of approximately 48” W x 30” L x 38” H

u. Automated, rotating IR polarizer

v. Widefield fluorescence

i. 4.2 MP high speed monochrome widefield epi-fluorescence camera with low dark noise and >90% quantum efficiency

ii. Dual camera integration with 5 MP color camera

iii. Motorized illuminator with fixed brightfield cube and up to 7 software-selectable filter cubes

iv. Cross-polarization and auto-fluorescence filter cubes

v. White light source with liquid light guide

vi. 50x dry objective (0.8 NA, 1 mm working distance)

V. Deliverables

The vendor shall deliver and install the instrument and all components specified above to the FDA/HFP laboratory facility located at 5001 Campus Drive, College Park, MD 20740. Delivery shall be made prior to September 30, 2025. If the vendor is not installing on the day of delivery, the delivery shall be made to the loading dock and moved into location on the date of installation. The vendor shall demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument shall not be accepted until those performance specifications have been met. The HFP project officer will perform inspection and acceptance of the mIRage-LS O-PTIR-R-FL microscope, or equal. The entire system shall be warranted for parts and labor for twelve (12) months from date of installation. Service and installation shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. A three (3) day on-site installation and training for FDA users will be arranged by the HFP project officer.

VI. Place of Performance

The work shall be performed at FDA/HFP, 5001 Campus Drive, College Park, Maryland, 20740. Delivery and installation of the instrument and all components specified above shall be coordinated through the HFP Project Officer. Work shall be conducted Monday through Friday, excluding federal holidays.

VII. Period of Performance

Delivery shall be made prior to September 30, 2025. The entire system shall be under warranty for parts and labor for twelve (12) months from date of installation.

Brand Name or Equal Statement:

This procurement is being conducted as a brand name or equal requirement in accordance with FAR 11.104 and FAR 52.211-6. Any offered product must meet or exceed each of the salient physical, functional, or performance characteristics identified in the requirements section of this Statement of Work. Offerors submitting an “equal” product shall provide sufficient documentation to demonstrate equivalency.