SOW- OC-2026-135595- Final Copy.pdf
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- Solicitation number
- OC-2026-135595
About this file
This Statement of Work describes a service contract for preventive maintenance and repair of a Peak Infinity XE6030 Nitrogen Generator (Serial Number: 722080281) located at the FDA's Office of Cosmetics and Colors in College Park, Maryland. The nitrogen generator supplies high-purity nitrogen gas to five LC/MS systems used to analyze color additives for compliance with 21 CFR Parts 74 and 82. The contract is urgent due to expired warranty coverage on the equipment.
The contractor must provide at least one annual on-site preventive maintenance visit, a guaranteed 48-hour on-site response time for breakdown repairs, and unlimited labor and travel during normal business hours (Monday-Friday, 8:00 AM to 5:00 PM). All replacement parts, labor, travel costs, protective packaging, and shipping expenses are the contractor's responsibility. Service must be performed by Peak-certified engineers and technicians, with the contractor required to demonstrate employee certifications. The contractor shall supply all necessary tools, parts, and materials. Technical support must be provided online as needed, and service personnel must comply with security screening procedures at the government facility. The performance period runs from September 14, 2026, to September 13, 2027. Service scheduling and coordination will be managed through Project Managers Nebebech Belai, PhD, and Samuel White, PhD.
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STATEMENT OF WORK
SERVICE CONTRACT FOR THE NITROGEN GENERATOR
Description of Purpose and Background:
The purpose of this request is to acquire a new service agreement for the Nitrogen Generator
(Model: Infinity XE6030, S/N: 722080281), which requires 48-hour on-site response time during normal business hours, unlimited labor and travel during normal business hours, and unlimited emergency calls.
Nitrogen generator provides a constant flow of high purity nitrogen gas to five Liquid
Chromatograph/Mass Spectrometer (LC/MS) systems in the Division of Color Certification and
Color Technology (DCCT). The LC/MS instruments are used to analyze batches of color additives intended for use in foods, drugs, medical devices, and cosmetics in the United States.
DCCT uses the LC/MS instruments for trace level analysis (sub ppm levels) in color additives submitted for certification.
Reliable and timely services, preventive maintenance, and repair services are critical for the instrument performance of the Nitrogen Generator. The Nitrogen Generator (Model: Infinity
XE6030, S/N: 722080281) is essential to ensuring program continuity within the Color
Certification Program, as it is used to determine whether each batch of color additive meets specifications outlined in 21 CFR Parts 74 and 82.
Scope:
The scope of the SOW is to acquire a new annual preventive maintenance agreement for the
OCAC’s Nitrogen Generator system. The service contract will ensure optimal instrument performance and extend instrument life expectancy, thereby supporting the Color Certification
Program’s mission. The Nitrogen Generator system shall be maintained and repaired under the new preventive maintenance agreement:
• Replacement parts, labor, and travel costs shall be covered by the Contractor.
• Service shall be provided by Peak’s certified engineers, technicians, and personnel using the relevant Nitrogen Generator equipment.
• At least one annual preventive maintenance service is performed.
• Responses to requests for maintenance and repairs shall be offered in a 48-hour response time.
• If parts must be shipped, the Contractor shall cover appropriate protective packaging and shipping costs.
Specifications necessary to meet the purpose:
The service agreement shall cover the following specifications to support the Nitrogen Generator
Peak system:
• At least one on-site Preventative service visit for factory-recommended preventive maintenance visit with labor and travel costs covered shall be provided by the Contractor.
• Requests services shall be provided by trained and authorized Peak certified engineers, technicians, and personnels.
• Full function check and Component retrofits shall be carried out when applicable by trained and authorized Peak certified engineers, technicians, and personnels.
• Nitrogen Generator Compressor repair shall be included when required.
• Nitrogen Generator breakdown or repair service including all breakdown/repair parts, labor and engineer travel charges shall be covered by the Contractor.
• Guaranteed on-site response time of 48 hours for break-down for the Nitrogen Generator shall be performed by the Contractor.
• Technical support shall be provided online as needed.
*Personnel: Contractor shall demonstrate that it employs the requisite personnel to repair and maintain Peak Nitrogen Generator system. The Contractor shall name the participating personnel and show that they are Peak-certified.
Period of Performance:
The performance period will be for base year from 09/14/2026 to 09/13/2027.
Contractor Provided Special Material Requirements:
Contractor shall supply all necessary tools, parts, and materials required to perform service, maintenance and repair.
Security:
This equipment is in a government-secured building. Service engineer 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 Contractor when a visit is scheduled.
Travel:
The Contractor will service the equipment at the FDA site. All travel expenses incurred by service engineers shall be covered by the Contractor.
Summary Statement of Urgency:
Acquisition of a new service agreement for the Nitrogen Generator Instrument is urgent because the current warranty coverage has expired.
Location of Service:
• The vendor shall provide service to the following location:
U.S. Food and Drug Administration
Office of Cosmetics and Colors
University Station (CPK2)
4300 River Road
College Park, MD 20740
Room 1096
• Service shall be scheduled with the Project Managers: Nebebech Belai, PhD and Samuel
White, PhD.
• Service shall be performed between Monday-Friday 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: Nebebech Belai and Samuel White.
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