Brand Name or Equal - Bruker Process Analytical Technology Probe for NIR

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. A SEPARATE SOLICITATION DOCUMENT ( I.E. STANDARD FORM ) WILL NOT BE ISSUED. The solicitation number for this acquisition is RFQ-FDA-75F40121Q00103 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation: 334516 Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. This is an unrestricted brand-name or equal full-and-open competition RFQ. Simplified acquisition procedures will be utilized. The U. S Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires one (1) Bruker Process Analytical Technology Probe for NIR (PATPNIR) or equivalent. Inquires Offerors must submit all questions concerning this solicitation in writing electronically to [email protected].. Questions must be received no later than July 21, 2021 5:00 p.m. Eastern Standard Time (EST). Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. Background Information The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Testing & Research (OTR) operates as an integrated testing and research FDA laboratory to develop scientific methods and tools to assess pharmaceutical quality issues and support the following core functions: standard, guidance, and policy development, pharmaceutical quality surveillance, quality assessment of regulatory submissions, and rapid response to public health emergencies. To fulfill its mission, OTR’s Division of Product Quality Research (DPQR) requires an NIR probe capable of collecting real-time data during a continuous manufacturing campaign of a solid oral dosage form. DPQR utilizes an NIR instrument from Bruker (Model Matrix MF Duplex). The required process analytical technology probe must be compatible and function seamlessly with the Bruker Matrix MF Duplex. As a real-time data collection tool, the probe may be retrofitted to strategic locations in a continuous line to accurately and precisely collect and rapidly transmit the reflected data to enable timely assessment and control of a process. DPQR requires the NIR probe to understand and monitor critical quality attributes of the in-process material and enable to keep the process under the state of control. Such understandings will ultimately help in supporting NDA and ANDAs review process. NOTE: Reference attachment titled, "RFQ_FDA_75F40121Q00103" for complete combined synopsis/solicitation.