SOURCE: US Federal Contractor Registration

US FEDERAL CONTRACTOR REGISTRATION

April 15, 2016 16:00 ET

FDA Seeks prepFAST 4DX Inline Auto Dilution System

Winning Bidder Must Be Able to Provide One-Year Warranty, Tech Support

SILVER SPRING, MD--(Marketwired - April 15, 2016) - The U.S. Food and Drug Administration (FDA) has issued a solicitation for a prepFAST 4DX inline auto dilution system (or equal) to dilute samples in automated fashion for the ICP-MS.

The Division of Product Quality Research (DPQR) has an important regulatory research role evaluating metal impurities in pharmaceutical drug products. ICP-MS is the latest instrument to detect metal impurities in sub parts per trillion (ppt) levels. Currently DPQR has an ICP-MS installed which is being used for several regulatory projects. Currently, the preparation time for samples (calibration, quality controls and unknowns) is quite significant and requires a substantial amount of manual intervention. 

DPQR requires an inline auto dilution system to dilute the samples in automated fashion for the ICP-MS. This instrument will help facilitate DPQR's mission of providing valuable laboratory-based analysis of pharmaceutical products including emerging products in biotechnology.

The provided inline auto-dilution instrument must be able to interface with the Division's current Nexion 300 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) and be operationally controlled by the ICP-MS control operating software with the following specifications:

  • Able to auto dilute, auto calibrate and dilute QCs (with inline internal standard mixing)
  • 4-Syringe pump dilution module (S400V)
  • Peltier cooled SSI spray chamber
  • DXi micro peripump
  • Integrated high speed valve
  • Sapphire injector
  • PFA nebulizer
  • Instrument cart approximately 24" X 14"X 36"
  • Software should be included that will interface with the existing Perkin-Elmer NexION 300D instrument control software and includes applicable software upgrades

The winning bidder must be able to:

  • Install the system and all components, including software, as well as calibrate and quantify
  • Demonstrate the instrument and train personnel
  • Provide at least a one-year warranty from date of installation that covers all labor, parts, and travel expenses required for repairs for equipment and software
  • Provide technical support and troubleshooting assistance via phone, email, or live-chat interface

The warranty shall start when equipment is installed and accepted by the FDA.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-87. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for full and open competition.

This solicitation is for a firm-fixed price contract, and the instrument must be delivered to the FDA's White Oak Campus in Silver Spring, MD by June 1, 2016. 

To bid on this or other federal contracts, you must have a complete and accurate System for Award Management (SAM) Registration. US Federal Contractor Registration, the world's largest third-party government registration firm, is available to help interested bidders complete a SAM Registration (if not already registered) or develop a bid for this or other contracts.

For more information call 877-252-2700, ext. 1 or visit uscontractorregistration.com

Contact Information

  • US Federal Contractor Registration
    877-252-2700, ext. 1