Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus

The U.S. Food and Drug Administration (FDA) is seeking potential providers who can supply a Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus. The apparatus should be able to perform solubility testing, have adjustable speed, and be able to operate multiple sample containers at the same time. The FDA is looking for a system that can help reduce the need for in vivo bioequivalence studies and support the development of a decision-making framework to identify similar formulations of a Sponsor's BCS Class III drug products. • The system should be able to maintain sample temperature at 37°C. • The system should be able to keep samples being stirred with adjustable speed during the incubation time. • The system should be able to operate multiple sample containers at the same time. • The system should be able to withdraw samples at different time points. • The system should be able to filter the withdrew sample in line or centrifuge the sample before sampling. • The system should have a warranty, including parts and labor, for at least one year. • The system should include delivery, installation, and on-site training.