Alberta Idealized Nasal Inlet (AINI), or equivalent instrument, with an Alberta Nasal Leak (or equivalent) test kit

The U.S. Food and Drug Administration (FDA) is seeking information from potential sources for an Alberta Idealized Nasal Inlet (AINI) with an Alberta Nasal Leak test kit. The AINI will be used for nasal deposition testing of spray dried powders for intranasal drug delivery. The system must meet specific requirements, including seamless integration with Copley Scientific Next Generation Impactor (NGI) and Fast Screening Impactor (FSI) systems, accurate mimicry of deposition behavior, and easy separation into component parts for drug recovery and assay. • The system must be a newly manufactured unit, not used or refurbished. • The contractor must provide all labor, travel, and tools for installation and onsite training. • The system must include operations and maintenance manuals, and warranty services for a minimum of one year. • The contractor must provide technical information to demonstrate that the offered services meet the technical requirements. • The contractor must provide information on the place of manufacture and compliance with the Buy American statute.