GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or equivalent

75F40126Q131715 1 of 14 This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is 75F40126Q131715. This solicitation is issued as a Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees. This requirement is solicited full and open, any sized business under the applicable NAICS may submit a quote. Schedule of Supplies or Services and Prices/Costs. Prices shall be inclusive of shipping and installation. Item # Description Est. QTY Unit of Measure Unit Price Extended Price 1 ConsiGma Standalone PAT Laboratory Test Rig (Basic Equipment) or equivalent instrument. 1 Ea $___________ $___________ Grand Total: $ ________________________ GSA Contract Number: __________________ (if applicable) Background The US FDA, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Continuous manufacturing (CM) of oral solids has been recognized as an emerging technology by the FDA. Continuous process monitoring and manufacturing process control are critical for establishment of a robust CM process that can consistently produce product of desired quality while identifying and mitigating manufacturing risks. Currently, OPQR possesses an integration platform that combines multiple powder feeders and a continuous blender. The integration platform is used to produce powder blend samples under specified experimental conditions. However, the existing platform lacks the capability to monitor the properties of the powder blend as it exits the blender. This package will expand the platform's capabilities to permit in-line property measurements of the resulting powder blend, as well as enable easier and more consistent blend sampling. Requirement The Center/Office/Program (COP) has a requirement for a GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or an equivalent product. The PAT rig will enable smooth, controlled flow of the powder blend over a near infrared (NIR) probe for consistent measurement of NIR spectra. The PAT rig will be adaptable to CM operation, including options for seamless integration of upstream and downstream unit operations. The NIR spectra of the flowing -- 1 of 14 -- 75F40126Q131715 2 of 14 powder blend, measured in real time, will be analyzed to assess various properties of the blend. This equipment will be essential in supporting the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for CM applications. Minimum Requirements/Specifications: The Process Analytical Technology (PAT) Rig shall: 1. Be constructed from stainless steel product contact metal surfaces with pharmaceutical grade metal finish. 2. Be constructed from FDA-compliant materials for all non-metal product contact equipment parts. 3. Have passed factory acceptance testing and site commissioning prior to shipping. 4. Be calibrated prior to shipping. 5. Undergo installation and operational qualification after installation, including recalibration if required. 6. Be portable with casters and brakes. 7. Consist of a vertical tube or chute through which pharmaceutical powders can flow with minimal to no mixing or turbulence. 8. Contain a sealable insertion point in the vertical tube or chute into which an NIR measurement probe between 10–20 mm in diameter can be inserted into the flowing powder with minimal to no disruption to powder flow. 9. Permit continuously adjustable speed at which powder exits the bottom of the vertical tube or chute to match the flow rate of the incoming powder. 10. Permit flow of cohesive powder through the tube or chute without impacting the accuracy or precision of an NIR spectrometer. 11. Be adaptable to continuous manufacturing operation which includes options for the seamless integration of upstream and downstream unit operations. 12. Include a minimum of one (1) year parts and labor with warranty from date of installation/commissioning. Delivery, Installation, Training and Additional System Requirements: 1. The components and equipment shall be newly manufactured, not used and refurbished or previously used for demonstration. 2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. 3. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. 4. Installation shall be conducted by factory-certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected. -- 2 of 14 -- 75F40126Q131715 3 of 14 5. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. 6. The Contractor shall provide all labor, travel, and tools to install, qualify, and recalibrate the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. 7. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization fo…