Inline Particle Sizing System

The U.S. Food and Drug Administration (FDA) is seeking to procure an Inline Particle Sizing System through a combined synopsis/solicitation. The agency requires a modular bench-top inline particle sizing system specifically designed for analyzing pharmaceutical drug products during manufacturing processes and for batch measurements. The system must utilize spatially resolved dynamic light scattering technology to measure particles ranging from 5-1000 nanometers, operate at flow rates between 1-20 mL per minute, analyze concentrated solutions without requiring dilution, and maintain sterile processing conditions throughout operation. The procurement will be evaluated using the Lowest Price Technically Acceptable (LPTA) method, meaning the lowest-priced technically compliant offer will be selected. Quotes are due by September 10, 2025 at 10:00 a.m. Eastern Time, and pricing must remain firm until September 30, 2025.

This procurement is designated as a small business set-aside under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 1,000 employees. The contract structure is a Firm-Fixed-Price commercial item purchase order with a performance period running from September 29, 2025 to September 28, 2026. The successful contractor must deliver the system within 60 days of contract award and complete installation at the FDA White Oak Campus located in Silver Spring, Maryland. While the solicitation notice does not specify the contract value or identify any incumbent contractors, it requires quotes for all line items to be submitted as part of the technical and pricing proposal. The procurement falls under PSC category 6640 for Laboratory Equipment and Supplies, reflecting the specialized nature of the analytical instrumentation being acquired.