Sources Sought Rees Scientific Environmental Monitoring Maintenance Services
ID: 25-000074Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Electronic and Precision Equipment Repair and Maintenance (811210)

PSC

MAINT/REPAIR/REBUILD OF EQUIPMENT- INSTRUMENTS AND LABORATORY EQUIPMENT (J066)

Original Source

https://sam.gov/opp/737ff7b642a14199b7af01999032ccf7/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking qualified contractors to provide validation, calibration, and preventative maintenance services for the Rees Scientific Environmental Monitoring/Alarm System at the Clinical Center's Center for Cellular Engineering in Bethesda, Maryland. The contractor will be responsible for ensuring compliance with regulatory standards by monitoring critical environmental parameters such as temperature, humidity, and gas levels in facilities that manufacture cell and gene therapies for clinical trials. This initiative is crucial for maintaining high standards in clinical research environments and ensuring the integrity of sensitive biological materials. Interested parties must submit their responses by email to Sheri Eiri at sheri.eiri@nih.gov by 12:00 PM EST on November 7, 2024, and must be registered in the System for Award Management (SAM) to be eligible for consideration.

    Point(s) of Contact
    Sheri Eiri
    000000000
    sheri.eiri@nih.gov
    Files
    Title
    Posted
    P09-25-000074 Draft Rees Environmental Monitoring SOW.pdf
    The U.S. Department of Health and Human Services, through the National Institutes of Health (NIH), seeks a contractor to provide validation, calibration, and preventative maintenance services for the Rees Scientific Environmental Monitoring/Alarm System at the Clinical Center's Center for Cellular Engineering. This system is vital for ensuring compliance with regulatory standards and monitoring critical environmental parameters such as temperature, humidity, and gas levels in cGMP facilities that manufacture cell and gene therapies for clinical trials. The contractor's responsibilities include supplying necessary equipment, performing operational qualification (OQ) and validation, maintaining comprehensive documentation, and offering 24/7 technical support. Regular preventative maintenance and on-site emergency repairs must be conducted, ensuring that the monitoring system operates optimally to protect sensitive biological materials. The contract period is set for twelve months at NIH's Bethesda, MD facility. All services must adhere to current good manufacturing practices (cGMP), and any software updates require governmental approval. This initiative underscores the NIH's commitment to regulatory compliance and the maintenance of high standards in clinical research environments.
    Lifecycle
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    Sources Sought Rees Scientific Environmental Monitoring Maintenance Services
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    Presolicitation
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