Description
Statement of Work Maintenance of Laboratory Equipment and Service: Malvern PANalytical Axios Wavelength-Dispersive X-Ray Fluorescence Spectrometer Background: Batch certification of color additives is a regulatory premarket enforcement function. The Color Certification Branch (CCB) evaluates physical appearance and chemically analyzes batch samples of color additives to determine whether each batch meets specifications described in 21 CFR Parts 74 and 82. Service support for Axios Wavelength Dispersive X-ray fluorescence (Axios WD-XRF) spectrometer at the Division of Color Certification and Color Technology will end on September 13, 2025. X-ray fluorescence (XRF) spectrometry is used to analyze samples of color additives that are used in foods, drugs, cosmetics and medical devices for elements with limiting specifications listed in 21 CFR Part 74. XRF is the primary analysis used to determine levels within the range of 1 – 1000 ppm. XRF is also used for official sample analyses when elemental composition is being determined. Description of Work: The following is a request for the acquisition of a new service agreement for the Axios WD-XRF, which includes 48-hour on-site response time during normal business hours, unlimited labor and travel during normal business hours, and unlimited emergency calls. Purpose: The Axios WD-XRF instrument is used for high throughput sample determinations of specified elemental impurities in certifiable color additives to support the certification (or rejection) of color additives as required under 21 CFR Part 74. Additionally, the instrument will be used for research in developing methods for the Color Certification Program and for the analysis of regulatory samples of unknown composition. Reliable and timely maintenance and repairs of the Axios WD-XRF is critical to the mission of the Color Certification Branch, which is to certify color additives for use in foods, drugs, and cosmetics. Specifications necessary to meet the purpose/objectives: The Division of Color Certification and Color Technology (DCCT) is requesting a new service agreement for the Axios WD-XRF that meets or exceeds the requirements/specifications listed below. Used or remanufactured instrumentation shall not be considered. Specification being requested: Service and support The vendor shall offer a warranty on the spectrometer, including labor, parts, on-site service with travel and housing, phone, and on-line support for the one-year warranty. The vendor shall provide service and application support within 48 hours and on-site repairs within 7 days. Provision of replacement parts with installation instructions through phone support . If Project Officer is unable to perform the installation of the replacement part(s), then Certified Engineer/Technician shall come on-site to perform repairs within seven days from the reported unsuccessful installation. Certified parts shall be used to restore the benchtop Axios WD-XRF to functional and operational specifications. At least one annual preventative maintenance (PM) shall be performed by the Contractor. Unlimited telephone and on-line support for hardware and software shall be performed by trained service Engineers/Technicians. On-demand service during normal business hours between Monday through Friday, 8:00 am to 5:00 pm (excluding holidays) at one of the following options: Unlimited telephone and on-line support with trained and certified service Engineers/Technicians. Repair parts (except the x-ray tube) are to be provided at no cost and will be covered under the contract for future replacement if necessary. Repair parts must be genuine Malvern PANalytical parts and be installed within 2 days of the service visit. All technicians both service and phone support must be Malvern PANalytical certified. On-site repairs at CPK2 location (Refer to the Section Location for further information ). Supplies and Services The Axios WD-XRF must include a maintenance service agreement that includes one on-site preventative maintenance service, unlimited service response within seven business days, unlimited software/firmware updates, parts, labor, and travel. All service conducted on the complete system, including maintenance and repairs, must be performed by qualified engineers/technicians that are trained and certified following manufacturer specifications to service the specific model offered and using original manufacturer parts. After servicing, the instrument must perform better or equal than when it was installed. Location The vendor shall provide service to the following location: U.S. Food and Drug Administration University Station (CPK2) 4300 River Road College Park, MD 20740 Room 1098 Service shall be scheduled with the Project Officers: To be provided at time of award. The Contractor shall perform service during the normal business hours (from 8:00 AM to 5:00 PM). Other times of performance shall be discussed and scheduled with the Project Officers: To be provided at time of award. Contractor shall perform maintenance and/or repairs as required by Project Officers: To be provided at time of award. Evaluation of Vendors Technical Experience Offeror shall demonstrate the ability to provide Malvern PANalytical certified engineers for both on site and phone support. On-site engineers must regularly perform on site repairs to Malvern PANalytical XRF equipment. Phone support technicians must provide unlimited technical phone support for Malvern PANalytical XRF equipment and SuperQ software. Offeror shall demonstrate the ability to obtain genuine Malvern PANalytical or equivalent repair parts in a timely manner and will provide those parts with warrantees at no additional cost to the FDA. Offeror shall demonstrate that it employs the requisite personnel to repair and maintain Malvern PANalytical XRF systems. The offeror shall name the participating personnel and show that they are Malvern PANalytical certified. Inspection and Acceptance The inspection and acceptance of the service will be handled by Kristen Reese and Corina McClure. Market Research Malvern PANalytical is the only source provider of factory parts and services required for the maintenance of the Axios Wavelength Dispersive X-ray Fluorescence spectrometer. Malvern PANalytical develops all service, preventive maintenance, parts, and calibration procedures. For further information, please see attached documents, FDA sole source letter and 2025 Malvern PANalytical sole source. Overall Price The offeror shall provide the best overall value for the FDA in terms of cost, relevant experience and approach. Period of Performance The performance period will be for option year #1 from 09/14/2025 to 09/13/2026. Summary Statement of Urgency Acquisition of a new service agreement contract for the Axios WD-XRF is urgent because the current service coverage expires on September 13, 2025, without an option for renewal. 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 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. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ *** Responses to this solicitation should not exceed 20 pages. ***