Isolator
ID: FDA-RFQ-24-121770Type: Combined Synopsis/Solicitation
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/59b5f3064e6f4af9b7b3581dc6dcfecf/view
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is seeking proposals for the acquisition of an isolator to support sterility testing at its New York Laboratory Medical Products (NYLMP). The isolator must meet specific technical specifications, including a modular design, built-in bio-decontamination features, and necessary technical integrations to comply with FDA standards, addressing the increased demand on existing resources. This procurement is crucial for enhancing analytical capabilities, improving workflow, and ensuring adherence to quality standards in laboratory operations. Proposals are due electronically by September 17, 2024, at 10:00 a.m. (EST), and interested parties should contact Nina Montgomery at nina.montgomery@fda.hhs.gov for further information.

    Point(s) of Contact
    Nina Montgomery
    (240) 402-8086
    nina.montgomery@fda.hhs.gov
    Files
    Title
    Posted
    RFQ- ISOLATOR 9.11.pdf
    The document is a Request for Quote (RFQ) from the FDA seeking proposals for the acquisition of an isolator to support sterility testing at the New York Laboratory Medical Products (NYLMP). The RFQ outlines specifications for the isolator, which must comply with various FDA standards and facilitate sterility testing processes, addressing increased demand and strain on existing resources. Key requirements include modular design, built-in bio-decontamination features, and necessary technical integrations to ensure compliance with regulations. Proposals are due by September 17, 2024, submitted electronically, and must demonstrate the ability to meet technical specifications. The government stipulates a lowest price technically acceptable (LPTA) evaluation method for selection. The contract includes installation, service, maintenance, and comprehensive training for NYLMP staff. The purpose is to enhance analytical capabilities, improve workflow, and ensure adherence to quality standards. The document emphasizes clear guidelines for submission, necessary documentation, and compliance with government regulations, indicative of the structured nature of federal procurement processes.
    Lifecycle
    Title
    Type
    Isolator
    Currently viewing
    Combined Synopsis/Solicitation
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