SAM #OC-2026-135595

FDA Sole Source Annual Service Agreement for Peak Scientific Infinity XE6030 Nitrogen Generator

This opportunity is for a sole source service agreement with Peak Scientific Inc. to support the FDA's critical laboratory equipment: - Agency: U.S. Food and Drug Administration (FDA), Office of Cosmetics and Colors, Division of Color Certification and Color Technology (DCCT) - Equipment: Peak Scientific Infinity XE6030 Nitrogen Generator (S/N: 722080281) - Purpose: Supplies high purity nitrogen gas to five LC/MS systems for color additive certification in foods, drugs, medical devices, and cosmetics - Service Requirements: - Annual preventive maintenance and repair agreement - At least one on-site preventive maintenance visit per year - Unlimited labor and travel during normal business hours - 48-hour guaranteed on-site response time - Compressor repair, breakdown/repair parts and labor - Technical support by Peak-certified engineers and technicians - Unlimited emergency calls - Compliance: Supports FDA's regulatory requirements under 21 CFR Parts 74 and 82 - Sole Source Justification: Peak Scientific is the only vendor referenced; service must be performed by Peak-certified personnel - Period of Performance: One year, from September 14, 2026, to September 13, 2027 - No specific part numbers for service components; instrument part number is Infinity XE6030 - Commercial opportunity for maintenance and repair services; estimated value likely in the $10,000-$30,000 range for annual service - Potential competitors include other nitrogen generator manufacturers, but only Peak Scientific is specified due to certification requirements

Description

The purpose of this request is to acquire a new service agreement for the Nitrogen Generator (Model: Infinity XE6030, S/N: 722080281). 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. 

Acquisition of a new service agreement for the Nitrogen Generator Instrument is urgent because the current warranty coverage has expired.

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.

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