Milliflex Rapid 2.0
ID: SSN_CDER-2025-126411Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/ffccafc5185c4960b2eebd0a76c48462/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking responses to a Sources Sought Notice for the acquisition of the Milliflex Rapid 2.0 microbial detection system. This procurement aims to enhance quality control testing for bioburden contamination in drug products, requiring a system that is compatible with the existing Milliflex Oasis filtration pump currently in use. The initiative is critical for ensuring compliance with quality control standards in pharmaceutical manufacturing, as it will bolster the FDA's capabilities in evaluating rapid microbial detection methods. Interested vendors must submit their responses by January 30, 2024, at 12:00 PM ET, directed to Contract Specialist Iris Johnson at Iris.Johnson1@fda.hhs.gov and Contracting Officer Maria Finan at Linda.Finan@fda.hhs.gov.

    Point(s) of Contact
    Iris Johnson
    Iris.Johnson1@fda.hhs.gov
    Maria Finan
    Linda.Finan@fda.hhs.gov
    Files
    Title
    Posted
    Draft_SOW_CDER-2025-126411.pdf
    The FDA's Office of Pharmaceutical Quality Research (OPQR) is seeking to acquire a rapid microbial detection system to enhance quality control testing for bioburden contamination in drug products. The required Milliflex Rapid System 2.0, which includes an autospray station and detection tower, must be compatible with the existing Milliflex Oasis filtration pump already in use. The SOW outlines specifications for hardware, installation, and training services expected from the contractor. Key requirements include certified technicians for equipment setup, on-site training, and the delivery within 45 days post-award. Moreover, proper scheduling coordination with the FDA's Technical Point of Contact is mandated for all maintenance activities. Overall, the initiative aims to bolster the FDA's capabilities in evaluating rapid microbial detection methods, ensuring compliance with quality control standards essential for pharmaceutical manufacturing.
    Sources Sought_CDER-2025-126411_FINAL.pdf
    The Sources Sought Notice (SSN) CDER-2025-126411 from the FDA's Office of Pharmaceutical Quality Research (OPQR) seeks market research and vendor identification for rapid microbial detection equipment. The equipment, specifically the Milliflex Rapid 2.0 system, is essential for confirming microbial contamination in pharmaceutical products. The FDA currently operates an older filtration pump but requires an upgraded system compatible with existing hardware. Vendors are invited to submit responses detailing their capabilities, including company information, size, socio-economic status, and domestic manufacturing status. The SSN outlines performance and delivery requirements, stipulating a one-year performance period, installation qualifications, and on-site training, with equipment delivery expected within 45 days of contract award. All inquiries and submissions must be directed to the designated FDA officials, with a response deadline set for January 30. This notice serves to gather information only and does not imply any commitment from the Government to award a contract.
    Lifecycle
    Title
    Type
    Milliflex Rapid 2.0
    Currently viewing
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