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Digestion System (Maintenance Agreement)

Active
Federal

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This maintenance agreement for a microwave digestion system is issued by the Food and Drug Administration to support the mission-critical Color Certification Program. The system is essential for ensuring chemical analyses comply with 21 CFR Part 74 and the Federal Food, Drug, and Cosmetic Act, specifically regarding the quantification of low-level heavy metals in color additives via inductively coupled plasma-mass spectrometry. The procurement focuses on obtaining an instrument with advanced stirring and temperature adjustment capabilities to handle complex chemical compositions that current equipment cannot process. The contract is categorized as a forecast and is designated as a Total Small Business Set-Aside under NAICS code 811219. It aims to facilitate proper sample preparation, method development, and the characterization of reference materials to maintain regulatory adherence. Administrative inquiries are directed to the Oc Acquisition Liaison within the FDA.

General Info

FDA small business contract for microwave digestion system maintenance for color certification program.

NAICS

811219 - Other Electronic and Precision Equipment Repair and Maintenance

Place of Performance

USA

Set-Aside

SBA

Documents

0

No documents available

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Office AddressN/A
Contacts
Oc Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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Digestion System option year/warranty. The microwave digestion system is critical for ensuring chemical analyses adhere to regulations per 21 CFR Part 74, which supports the FDA mission-critical Color Certification Program as required under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21 U.S.C. 379e]. The current equipment cannot digest samples with complex chemical compositions, limiting our ability to conduct required elemental analyses by inductively coupled plasma-mass spectrometry (ICP-MS) for heavy metals in color additives subject to batch certification. A new instrument with enhanced functions such as stirring and temperature adjustments will enable proper sample preparation, method development for the quantification of low-level heavy metals, and characterization of reference materials for samples with complex chemical compositions.

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