SAM #CDER-2026-133237

FDA Solicitation for Multitron HT Incubator Shaker System and Installation Services

The U.S. Food and Drug Administration (FDA) is seeking to procure a Multitron HT Incubator shaker system for advanced mammalian cell culture research at its Advanced Manufacturing Research Facility (AMRF) in Beltsville, Maryland. - Government Buyer: - U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Product Quality Research (DPQR), Advanced Manufacturing Research Facility (AMRF) - OEMs and Vendors: - No specific OEM or vendor is named in the solicitation - Products/Services Requested: - Multitron HT Incubator Shaker System - Triple-stack incubator configuration - Independent control of temperature, CO2, humidity, and orbital shaking - Compatible with 5-L Erlenmeyer shake flasks - Adjustable orbital shaking drive, integrated humidity and CO2 control, UV sterilization, dark observation window, cable passthrough port - IQ/OQ documentation and UL certification - Quantity: 1 unit - Services: - On-site delivery, installation, IQ/OQ qualification, and training for 1-3 end-users - Unique or Notable Requirements: - System must support simultaneous processing of multiple culture conditions and provide operational flexibility - Must be compatible with existing CHO suspension culture processes - Includes comprehensive installation, qualification, and user training - Vendors must demonstrate how their solution meets all salient characteristics; process development is not included - Place of Performance/Delivery: - Advanced Manufacturing Research Facility (AMRF), 5901 Ammendale Road, Suite D, Beltsville, MD 20705

Description

The Contractor shall provide a commercially available incubator shaker system that supports mammalian cell culture at production-relevant volumes under controlled environmental and agitation conditions.

The system shall:

Be compatible with existing CHO suspension culture processes Support simultaneous processing of multiple culture conditions Provide sufficient capacity and operational flexibility Operate reliably within a laboratory environment

This requirement is limited to the provision of equipment and associated services and does not include process development or modification of existing protocols.

Vendors shall clearly demonstrate how their proposed solution meets each salient characteristic.

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