The U.S. Food and Drug Administration (FDA) is seeking to award a purchase order to Repligen Corporation for the replacement of controllers and accessories for their Alternating Tangential Flow (ATF) Perfusion System. The system is used in conjunction with 5L Benchtop Glass Bioreactors for critical research and development activities. The replacement components must be 100% compatible with the existing system and bioreactors. The FDA is seeking capability statements from firms that can provide the required components and installation.
• The replacement components include XCell Lab Controller, XCell Lab HMI Kit, XCell Flow Sensor Cable Kit, and other accessories.
• The components must be compatible with the existing ATF Perfusion System and 5L Benchtop Glass Bioreactors.
• The installation must be done by the manufacturer to ensure system integrity and performance standards.
• The introduction of non-Repligen Corporation approved/manufactured components will violate current warranties/service agreements.
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