SAM #75F40126Q00095

FDA Solicitation for Triple-Stack Incubator Shaker System (Brand Name or Equal to INFORS HT Multitron)

The FDA's Division of Product Quality Research (DPQR) at the Advanced Manufacturing Research Facility (AMRF) is seeking to acquire a triple-stack incubator shaker system for mammalian cell culture research. - Government Buyer: - U.S. Food and Drug Administration (FDA), Division of Product Quality Research (DPQR), Advanced Manufacturing Research Facility (AMRF) - OEMs and Vendors: - INFORS HT (OEM of the referenced Multitron system) - Equivalent products from other manufacturers are acceptable if they meet or exceed the specified requirements - Products/Services Requested: - One (1) triple-stack incubator shaker system (brand name or equal to INFORS HT Multitron) - Must provide independent control of temperature, CO₂, humidity, and orbital shaking for each module - Triple-stack configuration with UV sterilization - Compatible with 5-liter Erlenmeyer flasks and suitable for CHO suspension cell culture - Includes all equipment, accessories, hardware, software, licenses, cables, and documentation - Turnkey delivery, installation, Installation Qualification (IQ), Operational Qualification (OQ), and on-site training for 1-3 personnel - Minimum one-year OEM warranty covering parts and labor - Unique/Notable Requirements: - Brand name or equal to INFORS HT Multitron; salient characteristics must be met for alternates - Delivery required within 90 days of award; installation within 10 days of delivery - IQ/OQ and training to be completed promptly after installation - System must be suitable for regulated laboratory environments and provide complete qualification documentation - Evaluation will be based on Lowest Price Technically Acceptable (LPTA) methodology

Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Product Quality Research (DPQR), Advanced Manufacturing Research Facility (AMRF), requires one (1) commercially available Triple-Stack Incubator Shaker System, Brand Name or Equal to the INFORS HT Multitron, to support mammalian cell culture operations. The system shall provide independent control of temperature, CO₂, humidity, and orbital shaking for each incubation module and support production-relevant working volumes for Chinese hamster ovary (CHO) suspension cell culture.

The Contractor shall furnish a complete turnkey system, including all equipment, accessories, hardware, software, licenses, cables, documentation, delivery, installation, Installation Qualification (IQ), Operational Qualification (OQ), on-site training, and a minimum one-year original equipment manufacturer (OEM) warranty covering parts and labor. Equal products must meet or exceed the minimum salient characteristics identified in the solicitation. Award will be made using the Lowest Price Technically Acceptable (LPTA) evaluation methodology to the responsible offeror whose quotation is determined technically acceptable and whose price is fair and reasonable

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