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CD14 Comparative Dissolution

The Teledyne Hanson 14-vessel CD14 dissolution tester runs two methods simultaneously or independently—ideal for bioequivalence studies of generic vs. innovator drug formulations. 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 comparative dissolution tester is able to test two different formulations with separate settings for every parameter under the same temperature conditions.

View CD14 Brochure

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.

CD14 FEATURES AND BENEFITS

 

  • The CD14 provides the smallest footprint in the 14-vessel class: 85 cm W x 61 cm D.
  • 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.
  • Compatible with many of the accessories found on our field-proven Vision testers.

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.

CD14 TESTER ORDERING INFORMATION

For more information, please contact your local Teledyne Hanson representative or email us at:
hansonsales@teledyne.com

 

DISSOLUTION SYSTEM PACKAGES

 

75-101-111 CD14 Manual Dissolution Package

Includes 14 Easi-Lock vessels, 14 Easi-Lock vessel covers, 14 spin-paddles (PVDF), 12 basket shafts (SS), 12 baskets (SS), 14 manual sampling cannulas, 1 jar of sample tip filters (1,000), Q-Pak, and certifications. Requires 2 power cords ordered separately.

 

75-101-121 CD14 AutoMag Dissolution Package

Includes 14 Easi-Lock vessels, 12 Easi-Lock ADD vessel covers, 2 Easi-Lock vessel covers, 14 Spin-paddles (PVDF), 12 basket shafts (SS), 12 baskets (SS), 14 manual sampling cannulas, 1 jar of sample tip filters (1,000), 12-position AutoMag, 12 digital temperature probes, 2 stackable apparatus trays, Q-Pak, and certifications. Requires 2 power cords ordered separately.


DISSOLUTION TESTERS

 

75-101-101 CD14 Dissolution Tester, 1 L
Includes tester only; order accessories and power cords (2 required) separately.


ACCESSORIES

 

74-105-201 Spin-Paddle, PVDF, Serialized

74-105-202 Spin-Paddle, 316 SS, Serialized

74-105-251 Spin-Basket Shaft, 316 SS, 1 L, Serialized

74-105-252 Basket, Precision, 40 Mesh, 316 SS, Serialized

74-107-090 Printer, Validation, 115/230 V, Epson

74-107-022 Vessel Cover, Easi-Lock

74-107-023 Vessel Cover, Easi-Lock ADD

75-107-101 Vessel, Easi-Lock, 1 L, Glass, Clear, Serialized

75-107-102 Vessel, Easi-Lock, 1 L, Glass, Amber, Serialized

75-107-121 Vessel, Easi-Lock, Super Precision, 1 L, Glass, Clear

75-107-122 Vessel, Easi-Lock, Super Precision, 1 L, Glass, Amber

75-107-150 Dual AutoMag, 12 Positions, Factory Installed

Includes magazine enclosures; order probe kits separately.

75-107-151 Dual AutoMag, 12 Positions, Field Installed

Includes magazine enclosures and mounting hardware; order probe kits separately.

75-107-160 Probe Kit, PEEK, 12 Positions, Sample and Return Probes, Factory Installed

Includes 12 PEEK sample probes, 12 RTV probes, 12 fluid blocks, 4 harnesses, and mounting hardware.

75-107-161 Probe Kit, PEEK, 12 Positions, Sample and Return Probes, Field Installed

Includes 12 PEEK sample probes, 12 RTV probes, 12 fluid blocks, 4 harnesses, and mounting hardware.

75-107-170 Probe Kit, SS, 12 Positions, Sample and Return Probes, Factory Installed

Includes 12 sample probes, 12 RTV probes, 12 fluid blocks, 4 harnesses, and mounting hardware.

75-107-171 Probe Kit , SS, 12 Positions, Sample and Return Probes, Field Installed

Includes 12 SS sample probes, 12 RTV probes, 12 fluid blocks, 4 harnesses, and mounting hardware.

75-107-180 Digital Temp Probes w/PCB, 12 Positions, Factory Installed

Includes 12 digital temperature probes.

75-107-181 Digital Temp Probes w/PCB, 12 Positions, Field Installed

Includes 12 digital temperature probes and installation hardware.


Q-PAK™ QUALIFICATION GUIDELINES

 

75-108-105 Q-Pak IQ/OQ/PQ Validation Guideline, CD14 – USP

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