The U.S. Food and Drug Administration (FDA) is seeking sources for an Automated Media Preparation Instrument for Dissolution Testing. The instrument should be capable of delivering a minimum volume of 250ml and a maximum volume of at least 1000ml, with a dispensing accuracy of ±5mL or less. It should also be equipped with in-line heating, have a temperature accuracy of ±2°C or better, and be capable of degassing media up to a maximum of 3.0ppm. The instrument should be portable and have an onboard controller and user interface.
• The instrument shall be capable of storing programmed methods and running in automatic or manual mode when preparing dissolution media.
• The instrument shall be capable of storing dispensing reports that include the volume and temperature dispensed.
• The instrument shall be compatible with media containing up to a maximum of 2% surfactants.
• The instrument shall have an electrical requirement compatible with a standard US outlet, 115V, 50 or 60 Hz.
The FDA is looking for vendors who can provide the equipment, delivery, installation, operator training, and warranty support. Responses should include company information, NAICS code, technical specifications, and domestic manufacturing status.
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