CD14 | Comparative Dissolution
Ideal for bioequivalence studies of generic vs. innovator drug formulations
- The Teledyne Hanson 14-vessel CD14 Comparative Dissolution Tester runs two methods simultaneously or independently.
- The 14 stirring positions allow for 6+1 or 12+2 configurations for improved workload efficiency in R&D, formulations, QC, and stability-test labs.
- With digital temperature probes at 12 positions the CD14 is able to test two different formulations with separate settings for every parameter under the same temperature conditions.
|Compatibility||Apparatus 1, 2, 5, and 6|
|Spindle speed||25 rpm to 250 rpm, accurate to ± 1 rpm with displayed resolution 0.1 rpm|
|Temperature||programmable from 25.0 °C to 50.0 °C with accuracy of ± 0.5 °C|
|Digital temp. probes||10 °C to 60 °C with accuracy of ± 0.1 °C from 30 °C to 55 °C, and displayed resolution of 0.01 °C|
|Compliancy||USP, EP, JP, US FDA Enhanced Mechanical Calibration and ASTM E2503 standards|
|Integration||CD AutoPlus™ autosamplers and AutoFill™ fraction collectors.|
|Dimensions||85 cm W x 61 cm D|
The CD14 is controlled by a fast, powerful computer built into the color touch screen display mounted to the drive head. The adjustable tilt angle accommodates operators of different heights while the Linux-based operating system with its own SQL database responds instantly to user input. The highly durable resistive touch screen works with gloves on or off. An easy-to-use interface includes context-sensitive help; logs for events, errors, test reports, test history, and service; rapid programming of new methods; ability to search database by any combination of fields; import/export including full system backup; programmable alarms for automatic power-on and warm-up; countdown to sampling points; tools including full system diagnostics; and more.
21 CFR PART 11
The CD14 onboard database stores up to 100 users with three levels of security (operators, managers, and administrators) with the ability to customize permissions and profiles at each level. The CD14 biometric fingerprint reader allows rapid enrollment of one or two fingers and provides positive ID of instrument operators. A password-only option is also included. Customize your own report formats and approval systems by specifying up to three signatures per report. An extensive audit trail records all system events and logs any changes made by users. System configurations are stored on-board and the system logs any changes to methods and configurations.
All critical components of the CD14 are identified by unique serial numbers traceable to the factory level including the spin-shafts installed into the drive head, all baskets and paddles, and all dissolution vessels. The part number and serial number of each vessel are laser-engraved into the top of the vessel rim in large, easy-to-read type, such that breakage of the glass will not destroy identifying information. The on-board database of the CD14 stores the system configuration including the serial numbers of all vessels, paddles, and baskets, and the position into which each item is installed.
Each dissolution vessel installs into an adjustable bracket attached to the vessel plate. These vessel-centering brackets allow precision adjustments to the dissolution vessel’s position in relation to the spin-shaft and any apparatus attached to it. The system allows fast and easy vessel centering to meet or exceed USP and/or ASTM mechanical calibration specifications.
The CD AutoPlus™ autosampler is designed to work with the CD14 Comparative Dissolution tester. The CD AutoPlus comes with 6 sampling channels, and DissoScan™ or Maximizer™ configurations. Precision syringe pump mechanics, all-inert tubing and valves, and color touchscreen programming with up to 100 protocols are standard on each instrument. The AutoFill™ is a precision fraction collector fully compatible with all AutoPlus autosampler models.