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.

 

 

 

CD14 Comparative Dissolution

Key Features

  • Precision vessel centering system exceeds the most demanding enhanced mechanical specifications.
  • Store up to 500 protocols (methods) on-board.
  • Run two different 6-vessel methods simultaneously or one 12-vessel method.
  • Rugged waterbath with low-position front port for ease of draining.
  • Heater/circulator slides out for ease of servicing.
  • Large color touch screen with adjustable tilt angle for operators of different heights.

Specifications

CompatibilityApparatus 1, 2, 5, and 6
Spindle speed25 rpm to 250 rpm, accurate to ± 1 rpm with displayed resolution 0.1 rpm
Temperatureprogrammable from 25.0 °C to 50.0 °C with accuracy of ± 0.5 °C
Digital temp. probes10 °C to 60 °C with accuracy of ± 0.1 °C from 30 °C to 55 °C, and displayed resolution of 0.01 °C
CompliancyUSP, EP, JP, US FDA Enhanced Mechanical Calibration and ASTM E2503 standards
IntegrationCD AutoPlus™ autosamplers and AutoFill™ fraction collectors.
Dimensions85 cm W x 61 cm D

CD14
Comparative Dissolution

FAST POWERFUL
COMPUTER CONTROL

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
COMPLIANCE

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.

SERIALIZED
COMPONENTS

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.

PRECISION VESSEL
CENTERING SYSTEM

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.

CD AUTOPLUS
AND AUTOFILL

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.

System Components

Accessories for Testing of Semisolids

Accessories for Testing of Semisolids

In conformance with methods such as USP Apparatus 5 – Paddle Over Disk, USP Apparatus 6 – Rotating Cylinder
Apparatus Trays

Apparatus Trays

Protect the integrity of your dissolution apparatus
Media Replace Beaker System

Media Replace Beaker System

Consists of a jacketed beaker that warms media to the intended test media temperature.
Filter Block Kit

Filter Block Kit

Eight positions accept compatible filters up to 33 mm in diameter
Adjustable Length Vessel-Mount Probes

Adjustable Length Vessel-Mount Probes

Fixed probe lengths are available for dissolution media volumes of 500 mL, 900 mL, and 2 liters
Fixed Length Vessel-Mount Probes

Fixed Length Vessel-Mount Probes

Fixed probe lengths are available for dissolution media volumes of 500 mL, 900 mL, and 2 liters
Manual Sampling Cannula

Manual Sampling Cannula

Made of PEEK (polyether ether ketone), have a 1/8″ diameter orifice, are adjustable, and use tip filters or in-line/syringe filters, typically with a Luer-type disposable syringe.
Basket and Paddles

Basket and Paddles

For testing transdermal products within the dissolution tester
Auto-Dosage Drop Vessel Covers

Auto-Dosage Drop Vessel Covers

Ideal for suspensions, solid dosage forms, and sinkers
Vessel Covers

Vessel Covers

Ideal for suspensions, solid dosage forms, and sinkers
Precision Dissolution Vessels

Precision Dissolution Vessels

A complete line of borosilicate glass dissolution vessels to accommodate a vast array of testing applications

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