Fully Automated HPLC Dissolution System

The U.S. Food and Drug Administration (FDA) is seeking a Fully Automated HPLC Dissolution System to replace an existing outdated system. The system must meet specific minimum technical requirements, including a water bath temperature range, voltage requirements, and the presence of certain features such as a hot water pressure booster pump and a multidose basket. The system will be used for drug product testing in support of the Office of Pharmaceutical Quality’s mission. • Must have a water bath temperature range from 5 to 40°C • Must have voltage requirements of 115V-2.0 Amp, 230V – 2.0 Amp • Must have fuse requirements of 115 V – 2.0 Amp, 250 V, 5 mm x 20 mm FAST • Must have hot water pressure booster pump • Must have Supplemental Media option includes CP 7-300 pump • Must have auxiliary Media Pump with valves • Must have multidose basket without cover • Must have video monitoring camera set including lighting • Must have paddle, laser beam welded electrolytic polished, 1.4461, for 7-station • Must have basket with shaft polished • Must have rack for vials 15 x 8 / 2 mL (d = 11,7 x 33 mm) • Must have vessels (USP), clear glass, 1000 mL • Must have sampling cannula • Must have sample management system • Must have controller PC monitor, keyboard, mouse • Must have fully automated, benchtop dissolution tester that handles media preparation, sampling, filtration, and system cleaning without operator intervention • Must have connection kit for bath • Must have sample management system • Must have filter station, 6-channel • Must have water bath, clear algae inhibitor • Must have stirrer electrolytic polished, 1.4460, for AT • Must provide on-site dissolution software, system installation, and familiarization • Must verify proper system operation via on-site performance testing • Must provide a 1-year parts and labor warranty on the system and 1-year of phone assistance