Process Analytical Technology (PAT) rig with Near Infrared (NIR) Spectrometer

The Food and Drug Administration's Office of Acquisition and Grant Services is seeking sources for a Process Analytical Technology (PAT) rig equipped with a Near Infrared (NIR) spectrometer, specifically referencing the ConsiGma standalone PAT Test Rig or equivalent product. The equipment must be newly manufactured (not refurbished) and constructed from stainless steel with pharmaceutical-grade finishes and FDA-compliant materials, featuring a portable design with casters, a vertical powder flow tube, an adjustable exit speed mechanism, and integration capability for continuous manufacturing processes. The NIR spectrometer component must operate within a 1200-2000 nm wavelength range and include a reflection probe with sapphire window, integrated data acquisition, and ASTM or NIST-traceable reference measurement accessories. All offerings must include factory-certified installation, comprehensive operations and maintenance documentation, on-site operator training for a minimum of two attendees, and one-year parts and labor warranty with ongoing technical support. Capability statements must be submitted by email to suzanne.martella@fda.hhs.gov by 10:00 am Central Time on April 24, 2026, with responses including business information, SAM Unique Entity ID, past performance documentation from the previous three years, technical literature demonstrating specification compliance, Buy American Act compliance information, and standard commercial terms.

This is a market research Sources Sought Notice with no set-aside designation, and importantly, no contract will be awarded from this solicitation, no reimbursement will be made for response costs, and this constitutes a written information survey only. There are no identified incumbent contractors or current vendors listed in the opportunity materials. The complete delivery, installation, qualification, and training must be accomplished within 40 weeks of contract award at the FDA CDER facility in Beltsville, Maryland; however, specific budget ranges or anticipated award values are not disclosed in this market research phase. The target NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees, though responses from all interested parties, including large businesses and domestic vendors, are welcome. This pre-solicitation notice serves as preliminary market research to identify qualified sources before a formal solicitation is issued.