SAM #75F40126SSN131715

FDA Solicits Pharmaceutical-Grade PAT Rig with NIR Spectrometer and Turn-Key Services

The U.S. Food and Drug Administration (FDA) is seeking information from vendors for a pharmaceutical-grade Process Analytical Technology (PAT) rig with an integrated Near Infrared (NIR) Spectrometer for laboratory use. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR) - OEMs and Vendors: - ConsiGma (mentioned as a potential OEM) - Equivalent manufacturers of PAT rigs and NIR spectrometers are also acceptable - Products/Services Requested: - Process Analytical Technology (PAT) Rig - 1 unit - Stainless steel construction, FDA-compliant materials, portable, adaptable to continuous manufacturing, includes 1-year warranty - Near Infrared (NIR) Spectrometer - 1 unit - Stainless steel, wavelength range 1200-2000 nm, high accuracy, integrated data acquisition, compatible with standard spectral software, 1-year warranty - Delivery, Installation, Qualification, and Training - Turn-key solution including all hardware, software, installation by factory-certified personnel, operational qualification, on-site operator training for at least two attendees, and warranty services for at least one year - Unique/Notable Requirements: - System must be pharmaceutical-grade and FDA-compliant - Factory acceptance testing, calibration, and qualification required - Warranty must cover parts, labor, and technical support for at least one year - Delivery, installation, and training to be completed within 40 weeks of contract award - Place of Performance: - FDA Center for Drug Evaluation and Research (CDER), 5901 Ammendale Road, Suite D, Beltsville, MD 20705

Description

See attached Sources Sought Notice (SSN) for a ConsiGma (or equivalent) Standalone Laboratory Process Analytical Technology (PAT) Test rig with Near Infrared (NIR) Spectrometer.

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