Description
The U.S. Food and Drug Administration (FDA) is seeking information to determine the availability and capability of providers who can supply an Advanced Freeze-Dryer that meets the specified General Requirements/Specifications. The FDA is looking for a laboratory-scale R&D lyophilizer with controlled ice nucleation and foam drying capabilities, as well as a tunable diode laser absorption spectrometry (TDLAS) system. The equipment should be made in America, and the FDA is encouraging responses from small business manufacturers. The key requirements for the Advanced Freeze-Dryer include:
• Controlled ice nucleation technology
• Foam drying capabilities
• Advanced process monitoring and control capabilities
• Integrable with digital twin technology
• AI-based process control strategies
• Capability to conduct full load traditional freeze drying with vacuum control
• Solvent trap for freeze-drying products with organic or cosolvents
• Rapid defrosting of ice after freeze drying using hot air or alternate approach
The FDA is seeking responses from interested parties, including small business manufacturers, to determine the availability and capability of providers who can meet the specified requirements.