Description
The U.S. Food and Drug Administration (FDA) is seeking vendors capable of providing a laboratory incubator shaker system to support mammalian cell culture at the Advanced Manufacturing Research Facility (AMRF). The system should be compatible with existing Chinese hamster ovary (CHO) suspension culture processes, support simultaneous processing of multiple culture conditions, and provide sufficient capacity and operational flexibility. 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.
Some key features of the system include:
* 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 control
* CO2 control system
* UV sterilization capability
* Dark observation window
* Cable passthrough port
* IQ/OQ documentation
* On-site installation and training
* UL certification
The contractor shall meet all established timelines and provide deliverables within 90-120 calendar days after award, including delivery, installation, IQ/OQ, and training.