SAM #75F40126Q131704

FDA Procurement of Fully Automated HPLC Dissolution System with Installation and Warranty

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Division of Product Quality Research V (DPQRV), is seeking to procure a Fully Automated HPLC Dissolution System to replace an outdated unit. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Division of Product Quality Research V (DPQRV) - Product Requested: - Fully Automated HPLC Dissolution System - Quantity: 1 unit - Must meet detailed technical specifications: - Water bath temperature range: 5 to 40°C - Voltage: 115V-2.0 Amp and 230V-2.0 Amp - Hot water pressure booster pump - Supplemental media pump CP 7-300 - Auxiliary media pump with valves - Multidose basket without cover - Video monitoring camera set with lighting - Paddle laser beam welded electrolytic polished 1.4461 for 7-station - Basket with shaft polished - Rack for vials 15 x 8 / 2 mL - USP clear glass vessels 1000 mL - Sampling cannula - Sample management system - Controller PC, monitor, keyboard, mouse - Fully automated benchtop dissolution tester (media preparation, sampling, filtration, system cleaning without operator intervention) - Connection kit for bath - Filter station 6-channel - Water bath with clear algae inhibitor - Stirrer electrolytic polished 1.4460 for AT - On-site dissolution software - System installation, familiarization, and on-site performance testing - 1-year parts and labor warranty - Services Included: - Installation - Training/familiarization - On-site performance testing - 1-year warranty (parts and labor) - Notable Requirements: - System must be fully automated and capable of handling all dissolution testing steps without operator intervention - Delivery is FOB destination to FDA/CDER in Silver Spring, MD - Firm-fixed-price contract - Open to all qualified vendors - No specific OEMs or part numbers are mentioned, but the requirements align with leading HPLC dissolution system manufacturers.

Description

See Attached Combined Synopsis/Solicitation 75F40126Q131704

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