“Brand Name or Equal” Milliflex Oasis Filtration Pump with option year periods of Post-Warranty Preventive Maintenance and Repair Services

The Food and Drug Administration's Center for Biologics Evaluation and Research is procuring two "Brand Name or Equal" Millipore Sigma Milliflex Oasis Filtration Pumps to replace existing equipment used for sterility and Growth Promotion Qualification testing. The solicitation has evolved through three amendments, initially seeking one pump with post-warranty maintenance services, then expanding to two pumps while removing the maintenance component, and finally refining the technical specifications and requirements. The procurement requires newly manufactured equipment that meets specific salient characteristics including compatibility with UV sterilization, two filtration heads, ability to withstand autoclaving, and integration with existing laboratory equipment. The contract will be awarded as a firm-fixed price commercial product using simplified acquisition procedures, with evaluation based on lowest-priced technically acceptable criteria. Offerors must submit their quotes by August 26, 2025, at 1:00 PM Central Time via email to the contracting officer Warren Dutter.

This solicitation is conducted under full and open competition with no set-aside designation, classified under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees. While no specific contract value is disclosed, the procurement represents a turn-key solution requiring installation, onsite qualification (IQ/OQ), on-site training, and a minimum one-year warranty with technical support. The quantity has been finalized at two filtration pumps following amendments that initially sought one pump and later maintenance services for up to four option years. Performance will occur at the FDA facility in Silver Spring, Maryland, with a 30-calendar day delivery period required from the contract award date. The current Milliflex equipment is being replaced because the existing models will be discontinued after 2025, making this a critical replacement procurement for the Division of Biological Standards and Quality Control's testing operations.