Section A – CD14 Tester Introduction
CD14 Tester & CD AutoPlus Autosampler User Guide—75-108-800 Rev. B—31 May 2021 7 of 130
EAR99 technology subject to restrictions on cover page.
Section A – CD14 Tester Introduction
The Teledyne Hanson 14-vessel Comparative 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.
The CD14 Tester is controlled by a fast, powerful computer
built into the color touchscreen 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 touchscreen 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.
The CD14 Tester 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 Tester’s 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 Tester 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-
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