SAM #FDA-75F40126Q00254

FDA Solicitation for Distek Model 2500 Dissolution System with Installation, Qualification, and Training

This FDA procurement opportunity is for a Distek Model 2500 Benchtop Dissolution System, including accessories, installation, qualification, and training. - Government Buyer: - U.S. Food and Drug Administration (FDA) - New York Medical Products Laboratory, Office of the Chief Scientist, Office of Analytical and Regulatory Laboratories - OEMs and Vendors: - Distek (OEM) - Products Requested: - Distek Model 2500 Dissolution System with Accessories - 1 unit - Includes: 6 spindle drives, water bath, touch screen interface, TCS-0500 Hideaway Thermocirculator, quick-change height adjustment, accommodates up to 8 vessels (100 mL to 2L), RPM control 25-300 RPM, vessel temperature control ambient to 55°C, serialized components, wireless RTD power pack and waterbath accessory kit, 6 wireless RTD shaft assemblies, 6 paddle blades (316 SS), 6 baskets (40 mesh), 6 basket adapters, 6 1L clear glass dissolution vessels, 6 Acculign rings, 6 flexible vessel covers, LED back light kit, software compliant with 21 CFR Part 11 - Product Training and Familiarization - Operator-level training for 5 users onsite, including manuals and consumables - Services Requested: - Installation and Qualification Services - Installation Qualification (IQ), Mechanical Qualification (MQ) per ASTM E2503-XXX and/or USP Toolkit Procedure, Performance Verification Test (PVT) per USP General Chapter , documentation, demonstration of system meeting salient characteristics, provision of solutions and accessories for maintenance, calibration, and qualification including USP Dissolution Performance Verification Standard tablets - Unique/Notable Requirements: - Delivery and installation inside FDA facility in Jamaica, NY within 6-8 weeks of award - One-year OEM warranty with unlimited on-site service - Training and qualification to be completed within two weeks after acceptance - Service reports required during warranty period - Compliance with 21 CFR Part 11 for software - Qualification and verification per ASTM and USP standards

Description

The Food and Drug Administration (FDA) requires a new Distek Model 2500 Dissolution System.

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