Requirements Documents_Revised.docx

STATEMENT OF WORK

Wavelength-Dispersive X-ray Fluorescence (WD-XRF) Spectrometer

Purpose:

This is a request for the Color Certification Branch (CCB) in the Division of Color Certification and Technology (DCCT) in the Office of Cosmetics and Colors (OCAC) to acquire a new wavelength-dispersive X-ray fluorescence (WD-XRF) spectrometer. The existing WD-XRF instrument is no longer supported by the manufacturer and the manufacturer’s service expires on 06/30/2026 and is not renewable. CCB requires a WDXRF capable of determining trace levels of arsenic (As), lead (Pb), mercury (Hg) and other elements in certifiable color additives.

Background:

Batch certification of color additives is a regulatory premarket enforcement function. Color additives (synthetic dyes) are used in foods, drugs, cosmetics, and medical devices. CCB conducts laboratory testing of color additives to determine whether a batch submitted for certification meets specifications described in the Code of Federal Regulations (CFR, Title 21, Parts 74 and 82).

WD-XRF is the primary technique used to determine trace levels of heavy metals (e.g., Pb, As, and Hg) in certifiable color additives in the range of 1-1000 ppm. Results obtained from WD-XRF analyses are used to certify or reject batches of color additives for elements with limiting specifications listed in 21 CFR Part 74.

CCB is requesting to purchase a new WDXRF instrument to provide continued analysis of trace level heavy metals. End of guaranteed service support for our existing Axios mAX WD-XRF spectrometer (Serial Number: 202764) expires on June 30, 2026. Reliable and timely maintenance and repair of this instrument is critical to the mission of the Color Certification Program.

Objectives The focus of this requisition is to acquire a new WD-XRF spectrometer that will allow program continuity to support the FDA’s mission-critical Color Certification Program.

The new XRF spectrometer will be used for high throughput sample determinations of elemental impurities in certifiable color additives to support the certification (or rejection) of certifiable color additives as required under 21 CFR Part 74. Additionally, the instrument will be used for research in developing new methods for the Color Certification Program, and for the analysis of regulatory samples of unknown elemental composition.

We are requesting a new WDXRF instrumentation with guaranteed service support that can provide timely maintenance and repairs. This procurement of the new WD-XRF spectrometer is critical to sustain CCB’s mission to certify color additives for use in foods, drugs, cosmetics, and medical devices.

Specifications necessary to meet the purpose/objectives:

CCB is requesting a new WD-XRF system that meets or exceeds the requirements/specifications listed below. The Contractor shall provide a WD-XRF system with all necessary supplies and accessories for installation, training, and operational performance of the analytical instrumentation. Used or remanufactured instrumentation shall not be considered.

Specifications being requested:

1. Sensitivity and precision

a. The Contractor shall provide an instrument capable of determining As, Pb, and Hg in the calibration range of 0.5-20 parts per million (ppm).

b. The Contractor shall demonstrate that the instrument can achieve a minimum limit of detection (LOD) of 0.5 ppm for As, Pb, or Hg in light element matrices.

c. The Contractor shall demonstrate that the instrument can achieve precision for As, Pb, and Hg in light element matrices of 0.2 ppm or lower in the calibration ranges.

d. The Contractor shall demonstrate that the instrument can quantify As and Pb in color additive samples containing bromine (Br).

i. The Contractor shall demonstrate that the instrument can achieve a minimum LOD of 1 ppm or lower for As and Pb in heavy element matrices.

ii. The Contractor shall demonstrate that the instrument can achieve precision of 0.5 ppm or lower for As and Pb in heavy element matrices in the calibration ranges.

e. Full analyte coverage from Beryllium (Be; Z=4) to Uranium (U, Z=92), with general quantitation levels ranging from sub-ppm levels to high percent by weight.

2. Sample changer/autosampler

a. The instrument must demonstrate that the sensitivity and precision can be met while allowing for continuous sample throughput. To this endpoint, the Contractor shall demonstrate that the instrument provides:

i. Capability for both system automated and manual loading of samples

ii. Capability to load samples externally during system operation.

iii. Capability to recognize sample types including solid, liquid, and powder.

iv. Capability to measure multiple applications in one run from the same sample changer tray.

b. The instrument must be capable of holding and running at minimum 50 sample cups from the sample changer tray(s).

3. X-ray tube

a. The instrument must have a primary excitation X-ray tube (anode Rhodium) with no less than 2.4 kW power supply to achieve the excitation needed for the sensitivity and precision requirements stated in Specification 1.

b. The x-ray tube end window shall be no thicker than 75 μm.

c. X-ray tube should be able to operate between 20-60 kV and 10-160 mA.

4. Primary Beam + Optical Path

a. The instrument must contain components capable of modifying the spectral composition of the primary X-ray beam to reduce background noise and enhance sensitivity for specified target elements (filters or equal).

b. The instrument must contain components capable of automatically controlling the divergence of the X-ray beam (collimators or equal) into fine, medium, and course spot sizes for controlled analysis of light, medium, and heavy elements

5. Goniometer and Analyzing Crystals

a. Included goniometer shall include multiple high-quality analyzer crystals suitable for our WD-XRF spectrometry applications to improve the sensitivity of elemental measurements.

b. The instrument shall include the following types of crystals:

i. LiF 220 crystal for enhanced resolution (V - Am)

ii. LiF 200 crystal (K - Am)

iii. Synthetic crystal for Al - Cl

iv. Synthetic crystal for O – Mg

v. Synthetic crystal for P – Cl

6. Detection/ Counting Electronics

a. The instrument shall include at a minimum two detectors capable of prioritizing the detection of light and heavy elements.

b. The instrument shall include a flow proportional counter and scintillation counter type of detectors.

c. The detectors shall be capable of measuring high count rates in millions of counts per second (Mcps) to deliver high detector linearity and lowest detection limits.

d. The instrument shall include the added capability to perform energy dispersive x-ray fluorescence (ED-XRF) through a separate channel in addition to WD-XRF, able to generate a spectrum for the energy range of 1- 40 keV and capable of detecting elements with a characteristic line in this region.

7. Computer and software

a. The instrument operating software must be fully compatible with Windows 11 OS.

b. This software must be in accordance with FDA’s Information Technology guidelines.

c. The instrument shall include software capable of the following:

a. Ability to define spectral peaks above background noise, predict element identity, and resolve complex peak overlaps through deconvolution

b. Both standardless analysis and quantitative analysis

c. Perform qualitative data acquisition for both the WD scan modes

d. Calibrate and quantitate for both the WD a scan modes

e. Standardless analysis software capable of semi-quantitative measurements

f. Monitor for instrument drift and apply corrections

g. Capable of measuring Compton scattering to correct measurements for matrix effects

h. Use Fundamental parameters (FP) methods to estimate quantitation of elements without standards

i. Update instrument calibrations per application

j. Process data to generate full spectrum reports and/or quantitative data reports

8. Service and support

a. The Contractor shall offer a warranty on the WD-XRF, including full-coverage for labor, parts, on-site service with travel and housing, phone support, and on-line support.

b. The warranty should include unlimited on-site visits and phone calls.

c. The Contractor shall offer at least one additional option year(s) of service extended warranty beyond the standard first-year warranty.

d. The Contractor shall cover parts, labor, and travel for repairs and defects within the service agreements at no cost of CCB and government.

e. Service agreement shall include one preventative maintenance, and unlimited repairs as needed. The Contractor shall provide service and application support within 24 hours and on-site repairs within 3-5 days of the initial contact.

f. Service must be performed by engineers/technicians trained and certified following the manufacturer specifications.

g. Any travel expenses incurred by the visiting engineer/technician shall be covered by the Contractor.

h. Certified parts (original equipment manufacturer parts) shall be used to restore the WD-XRF to optimal operational specifications.

i. At least one annual preventative maintenance (PM) shall be performed by the Contractor.

j. Unlimited telephone and on-line support for hardware and software shall be performed by trained service Engineers/Technicians.

k. On-demand service during normal business hours between Monday through Friday, 8:00 am to 5:00 pm (excluding holidays).

9. Training and Installation

a. Contractor shall provide on-site installation and training for up to 2 trainees.

b. The complete system including instrumentation, associated software, and all hardware must include full training for a minimum of two employees that is conducted on-site.

c. The instrument shall be delivered with all necessary supplies and accessories required for the installation and training.

10. General Specifications

a. The system, if a floor-standing unit, shall be designed with integrated support structures.

b. The system shall not exceed the following footprint: 85 cm width, 110 cm depth, 155 cm height

c. The system should operate within ambient room temperature laboratory conditions.

d. The Contractor shall provide the entire system including all supplies and accessories for immediate start-up and installation at the designated laboratory delivery location.

e. Necessary peripherals (e.g., chiller/heat exchangers) required for instrument installation shall be provided by the Contractor.

Contractor Provided Special Material Requirements

The Contractor shall supply the necessary tools required to perform the instrument installation, maintenance service, and repairs.

Security

The equipment is to be installed in a government-secured building. Visiting engineers/technicians will adhere to security screening upon arrival and will be escorted into the building by personnel from OCAC. Additional security requirements will be communicated to visiting engineers/technicians upon scheduling.

Place of Performance

The installation, maintenance, any necessary repairs of the equipment, and all training will be performed at the FDA site where the equipment is located, currently at the following address:

U.S. Food and Drug Administration University Station (CPK2) Room 1098 4300 River Road College Park, MD 20740

Work shall be conducted Monday through Friday (from 8:00 AM to 5:00 PM), excluding federal holidays. Scheduling is to be coordinated through the Contracting Officer Representative (COR) . Other times of performance shall be discussed and scheduled with the COR.

Period of Performance The Contractor shall deliver the instrument to the location listed under Place of Performance award and installation shall be coordinated with the Project Officer.

Inspection and Acceptance

The inspection will be conducted by Project Officers and COR. The acceptance of the system will be handled by the COR.

Summary Statement of Urgency

Replacement of the current WD-XRF is urgent because the equipment is being phased out and its service contract is no longer guaranteed. There is no guarantee of a repair should the current instrument cease to function properly. Acquisition of a new instrument will allow continuity of color additive sample analysis to support FDA’s mission critical Color Certification Program by enabling CCB to determine CFR-specified and non-specified elemental impurities at trace levels in color additives.

Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

· New Year’s Day

· Martin Luther King Day

· President’s Day

· Memorial Day

· Juneteenth Day

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure (e.g., applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.