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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 is able to test two different formulations with separate settings for every parameter under the same temperature conditions.

 

CD14 EFFICIENCY AND PRODUCTIVITY

  • Smallest footprint in its 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.
  • Rugged waterbath with low-position front port for ease of draining.
  • Large color touch screen with adjustable tilt angle for operators of different heights.

 

21 CFR PART 11 COMPLIANCE

  • Up to 100 users with three-levels of security and customizable profiles at each level.
  • Biometric fingerprint reader for positive ID of users, plus password-only option.
  • Customizable report formats with up to three signatures per report.

CD14 TESTER SPECIFICATIONS

  • Compatible with 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 temperature 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.
  • Compliant with USP, EP, JP, US FDA Enhanced Mechanical Calibration and ASTM E2503 standards.

 

CD14 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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