SAM #75F40126SSN133298

FDA CDER Seeks Alberta Idealized Nasal Inlet (AINI) or Equivalent System with Test Kit and Turnkey Services

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Testing and Research is seeking a turnkey solution for nasal deposition testing instrumentation: - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER), Office of Testing and Research - OEMs and Vendors: - Copley Scientific (referenced for device compatibility) - Alberta Idealized Nasal Inlet (AINI) (referenced as the target instrument) - Products/Services Requested: - Alberta Idealized Nasal Inlet (AINI) or equivalent instrument (1 unit) - For installation on Copley Scientific Next Generation Impactor (NGI) and Fast Screening Impactor (FSI) - Must meet integration, accuracy, separability, and certification requirements - Alberta Nasal Leak (or equivalent) Test Kit (1 unit) - For verifying integrity and sealing of the AINI system - Must include all necessary components, fixtures, and instructions - Compatible with AINI and impactor devices - Delivery, installation, and onsite training for 3-5 users - Installation by factory certified personnel - Onsite factory acceptance test, validation documentation, and operator training - Minimum one-year warranty with technical support, troubleshooting, and access to replacement parts and updates - Unique/Notable Requirements: - System must be new and turnkey - Delivery, installation, verification/qualification tests, and training must be completed within 90 days of contract award - Compatibility with Copley Scientific NGI and FSI devices is mandatory - Includes warranty and comprehensive support services

Description

See attached Sources Sought Notice (SSN) for the FDA's requirement for an Alberta Idealized Nasal Inlet (AINI), or equivalent instrument, with an Alberta Nasal Leak (or equivalent) test kit. The AINI will be installed on Copley Scientific Next Generation Impactor (NGI) and Fast Screening Impactor (FSI) testing devices to be used for nasal deposition testing of spray dried powders for intranasal drug delivery. 

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