The U.S. Food and Drug Administration (FDA) is seeking a commercially available incubator shaker system to support mammalian cell culture operations at the Advanced Manufacturing Research Facility (AMRF). The system should have a triple-stack configuration, independent control of temperature, CO₂, humidity, and orbital shaking for each module, and be compatible with 5-liter Erlenmeyer shake flasks. The contractor shall provide all equipment, accessories, hardware, software, cables, utilities, documentation, and ancillary components necessary to furnish a complete, fully functional system. The system should be fully operational upon completion of installation and qualification, and the contractor shall provide on-site installation, IQ/OQ, and training.
• The system should have a triple-stack incubator shaker configuration.
• The system should have independent control of temperature, CO₂, humidity, and orbital shaking for each module.
• The system should be compatible with 5-liter Erlenmeyer shake flasks.
• The system should have an adjustable orbital shaking drive.
• The system should have integrated humidity control.
• The system should have integrated CO₂ control.
• The system should have UV sterilization capability.
• The system should have a dark observation window.
• The system should have cable passthrough capability.
• The system should have IQ/OQ documentation.
• The system should have on-site installation.
• The system should have on-site training.
• The system should have UL certification or equivalent.
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