Description
The U.S. Food and Drug Administration (FDA) is seeking a Subcutaneous Injection Site Simulator (SCISSOR) system to address critical regulatory research needs for the evaluation of complex long-acting injectable drug products. The system should be a complete subcutaneous injection site simulator consisting of multiple independent chambers with integrated optical detection systems, automated sampling capabilities, and comprehensive software control for hardware operation and data management. The system should have a minimum of six independent chambers for simultaneous testing of multiple samples, with each chamber having independent temperature and flow control capabilities. The system should also have integrated camera or imaging systems for real-time visual monitoring of gel formation, structure evolution, and dissolution processes. Other key features include automated injection and fraction collection systems, optical detection and monitoring systems, and software control and data management capabilities.
• The system should be compatible with standard laboratory power and have a reasonable laboratory footprint.
• The system should have simultaneous control and monitoring of all chambers with independent parameter settings.
• The system should have automated system integration, full control and coordination of automated injection and fraction collection systems.
• The system should have export capabilities for data analysis in standard formats.
• The system should have a comprehensive user manual and operating procedures.
• The system should have a one-year full manufacturer’s warranty from the date of FDA acceptance of the system.