Teledyne CD14 User manual
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CD14 COMPARATIVE DISSOLUTION TESTER
AND
CD AUTOPLUS AUTOSAMPLER
USER GUIDE
75-108-800-Rev. B—31 May 2021
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About Teledyne Hanson
Teledyne Hanson, a division of Teledyne
Instruments, Inc., is a global technology
company specializing in analytical test
instruments for the pharmaceutical industry.
Founded by the innovator of modern
dissolution test technology, Teledyne Hanson
helps ensure the world’s pharmaceuticals are
pure, safe, and effective by manufacturing
equipment that sets the global standard for
quality, innovation, and long-term value.
Teledyne Hanson instruments are used by
scientists in over 75 countries worldwide and
are supported by the industry’s top customer
service team. For more information, visit
teledynehanson.com.
Headquarters
Teledyne Hanson
9810 Variel Avenue
Chatsworth, CA 91311, USA
Phone: +1 818.882.7266
www.teledynehanson.com
Sales and Support
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Congratulations on your purchase of the Teledyne Hanson CD14 Comparative
Dissolution tester and CD AutoPlus™ Autosampler. While we are certain you will
enjoy these new products, we also understand from time to time you may have a
question or technical issue requiring our assistance. Please feel free to contact us at
any time by any of the methods below.
Website: teledynehanson.com
Tech support request form: teledynehanson.com/tech-support-request
Email: [email protected]
Email: [email protected]
Phone: +1 818.882.7266
Teledyne Hanson
9810 Variel Avenue
Chatsworth, CA 91311, USA
Revision History
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Document Revision History
Note: To confirm that you have received the latest version of this
user guide, contact Teledyne Hanson Technical Support.
REVISION DATE DESCRIPTION
A 10 July 2020 Initial release.
B 31 May 2021 Added CD AutoPlus autosampler accessory
information and instructions.
Table of Contents
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Table of Contents
SECTIONA–CD14TESTERINTRODUCTION.....................................................................................7
FEATURES...............................................................................................................................................8
CD14COMPARATIVEDISSOLUTIONTESTERIDENTIFICATION............................................................................9
SECTIONB–CDAUTOPLUSSAMPLERINTRODUCTION..................................................................10
SECTIONC–REGULATORYANDSAFETY........................................................................................15
REGULATORYCOMPLIANCE......................................................................................................................15
CANADIANEMISSIONSNOTICE.................................................................................................................15
CD14TESTERGENERALSAFETYCONSIDERATIONS.......................................................................................15
CD14TESTERSAFETYCONSIDERATIONS.....................................................................................................16
SAFETYSYMBOLS...................................................................................................................................17
CD14TESTERWARNINGLOCATIONS.........................................................................................................17
CDAUTOPLUSGENERALSAFETYCONSIDERATIONS......................................................................................18
CDAUTOPLUSCSASAFETYCONSIDERATIONS............................................................................................18
SECTIOND–TESTERINSTALLATION..............................................................................................2 0
QUICKSTART........................................................................................................................................20
LOCATION.............................................................................................................................................20
ENVIRONMENTALREQUIREMENTS.............................................................................................................20
SPACEREQUIREMENTS............................................................................................................................21
ELECTRICALREQUIREMENTS.....................................................................................................................21
GENERALUNPACKINGANDINSTALLATION...................................................................................................22
UNPACKINGTHECD14TESTER................................................................................................................22
ATTACHLIFTINGHANDLES.......................................................................................................................23
REMOVECOUNTER‐WEIGHTSHIPPINGBOLTS.............................................................................................24
MOVINGTHEUNIT.................................................................................................................................25
LIFTINGTHEUNIT...................................................................................................................................25
SAFETYFIRST........................................................................................................................................25
LEVELTHEUNIT.....................................................................................................................................28
HEATERASSEMBLY.................................................................................................................................30
HEATERINSTALLATION............................................................................................................................31
FILLINGTHEBATH..................................................................................................................................36
STARTTHEPUMP...................................................................................................................................37
TESTERINSTALLATIONISCOMPLETE...........................................................................................................38
SECTIONE–AUTOSAMPLERINSTALLATION..................................................................................39
LOCATION.............................................................................................................................................39
ENVIRONMENTALREQUIREMENTS.............................................................................................................39
SPACEREQUIREMENTS............................................................................................................................39
ELECTRICALREQUIREMENTS.....................................................................................................................39
UNPACKINGANDINSPECTION...................................................................................................................39
ELECTRICALCONNECTIONS.......................................................................................................................40
Table of Contents
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CDAUTOPLUSTOAUTOFILLCOMMUNICATIONCONNECTIONS......................................................................42
VERIFYINGSYRINGEFUNCTIONS................................................................................................................46
VERIFYINGCOLLECTORFUNCTIONS............................................................................................................48
SECTIONF–OPERATION...............................................................................................................50
DRIVEHEADMOVEMENT........................................................................................................................50
PADDLEANDBASKETINSTALLATION...........................................................................................................50
VESSELINSTALLATION.............................................................................................................................51
CONFIGURATIONANDPROGRAMMING.......................................................................................................52
MAINSCREEN.......................................................................................................................................52
USERINTERFACESCREENS.......................................................................................................................55
INSTRUMENTSETUP...............................................................................................................................56
TITLESBUTTON......................................................................................................................................59
FIRMWAREUPDATE................................................................................................................................62
SECURITY..............................................................................................................................................62
DIAGNOSTICS........................................................................................................................................66
INFORMATION.......................................................................................................................................66
DISPLAY...............................................................................................................................................71
TIME/ALARMS......................................................................................................................................72
TOOLSBUTTON.....................................................................................................................................77
SECTIONG–DISSOLUTIONTESTING..............................................................................................8 1
METHODS............................................................................................................................................81
METHODSCREEN...................................................................................................................................83
HOWTOSTARTATEST............................................................................................................................90
MANUALSTAGGEREDSTARTWITHCD14TESTER........................................................................................94
SECTIONH–CD14TESTERMAINTENANCE....................................................................................97
SCHEDULEDMAINTENANCEOVERVIEW......................................................................................................97
O‐RINGINSPECTIONANDREPLACEMENT....................................................................................................98
BELTREPLACEMENT...............................................................................................................................98
DRAININGTHEWATERBATH.....................................................................................................................99
GUIDELINESFORCLEANINGTHEWATERBATH..............................................................................................99
ADJUSTMENTSANDCALIBRATION..............................................................................................................99
SPINDLESHAFTHEIGHTADJUSTMENT........................................................................................................99
HEATERANDTEMPERATUREPROBEADJUSTMENT........................................................................................99
MOVINGANDSTORAGE–CD14TESTER..................................................................................................100
SECTIONI–CDAUTOPLUSMAINTENANCE..................................................................................101
SCHEDULEDMAINTENANCEOVERVIEW....................................................................................................101
WASHROUTINE...................................................................................................................................101
CDAUTOPLUSGENERALCLEANING........................................................................................................103
SYRINGEREPLACEMENT........................................................................................................................103
VOLUMECALIBRATION..........................................................................................................................104
TUBINGVOLUME.................................................................................................................................105
RINSEVOLUME....................................................................................................................................106
CARRYOVER........................................................................................................................................108
CDAUTOPLUSMOVINGANDSTORAGE...................................................................................................111
Table of Contents
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SECTIONJ–TROUBLESHOOTING.................................................................................................112
CONTACTINGTELEDYNEHANSONFORTECHNICALSUPPORT.........................................................................112
ELECTRICALTROUBLESHOOTING..............................................................................................................113
MECHANICALTROUBLESHOOTING...........................................................................................................114
HEATERTROUBLESHOOTING..................................................................................................................115
AUTOMAGTROUBLESHOOTING..............................................................................................................116
SERIAL(VALIDATION)PRINTERTROUBLESHOOTING....................................................................................117
SERIAL(VALIDATION)PRINTERSELF‐TEST.................................................................................................117
NETWORKPRINTERTROUBLESHOOTING...................................................................................................118
SECTIONK–SPECIFICATIONS......................................................................................................119
CD14COMPARATIVEDISSOLUTIONTESTERSPECIFICATIONS........................................................................119
HEATERSPECIFICATIONS........................................................................................................................119
CD14TESTERGENERALSPECIFICATIONS..................................................................................................120
CDAUTOPLUSSPECIFICATIONS..............................................................................................................120
AUTOFILLSPECIFICATIONS.....................................................................................................................121
CDAUTOPLUS/AUTOFILLGENERALSPECIFICATIONS..................................................................................122
WETTEDMATERIALS............................................................................................................................123
SECTIONL–GENERALWARRANTY..............................................................................................125
APPENDIXA:ERRORS.................................................................................................................126
CD14TESTERERRORS..........................................................................................................................126
Figures and Diagrams
FIGUREA‐1:IDENTIFICATIONOFTHECD14TESTER............................................................................................9
FIGUREB‐1:CDAUTOPLUS/AUTOFILLIDENTIFICATION....................................................................................13
FIGUREB‐2:IDENTIFICATIONOFTHECDAUTOPLUSFLUIDICS............................................................................14
FIGUREC‐1:CDAUTOPLUS/AUTOFILLPOTENTIALPINCHHAZARDS....................................................................19
FIGUREE‐1:CDAUTOPLUSBACKPANELANDPORTS.......................................................................................40
FIGUREE‐2:AUTOFILLBACKPANELANDPORTS..............................................................................................41
FIGUREE‐3CDAUTOPLUS/AUTOFILLCONNECTIONS.......................................................................................42
FIGUREF‐1:SHAFTCLAMPANDKEYINPOSITION.............................................................................................51
FIGUREF‐2:AUTOMAGCALIBRATIONTOOLINPLACE......................................................................................79
TABLEK‐1:WETTEDMATERIALS.................................................................................................................123
Section A – CD14 Tester Introduction
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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-
Section A – CD14 Tester Introduction
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board database of the CD14 Tester 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.
Features
The new CD14 dissolution testers take the next step in
dissolution testing with a streamlined new design and
increased functionality. Here are some of the new features.
Standard Features
Compact footprint
Easi-Lift™ moveable drive head with brake
14 precision drive spindles with spindle shafts
14-position vessel plate
Standard footprint, 4 across x 3 deep with 2 center positions
Automation-ready (with optional AutoMag™)
Precision control for speeds 25 - 250 rpm, temperature 25 - 51 ºC
Elegant, ergonomic design with workhorse performance
Highest quality components and engineering
Minimal user adjustments for easy setup and go
Independent heater system located under the tester
Rugged molded waterbath with fast heat-up and low-level drain
port
Digital temperature probe (1) for use in bath and vessels
Full color touchscreen with intuitive menus and programming
Store hundreds of methods (create, manage, and save routines)
Upload and download programs with flash drive
Electronics and firmware include 32-bit digital technology
Print to both serial and network printers
Alarms for sampling, maintenance, and calibration
Security system supports 21 CFR Part 11 compliance
USP / FDA / ASTM / EP / JP compliant
CE / RoHS compliant, includes earth-friendly packing
Section A – CD14 Tester Introduction
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CD14 Comparative Dissolution Tester Identification
Figure A-1: Identification of the CD14 Tester
Section B – CD AutoPlus Introduction
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Section B – CD AutoPlus Sampler
Introduction
The CD AutoPlus™ is a programmable precision syringe-
pump sampling instrument that handles a wide variety of
dissolution applications and requirements. The basic
instrument consists of 6 precision glass sampling syringes
driven by a stepper motor, with internal valve interfacing, in
one compact ergonomic instrument package. PTFE tubing
harnesses connect to a CD14 Tester, multi-cell changers for
on-line UV/VIS sample analysis, as well as collection trays for
sample archive.
The CD AutoPlus can be directed to withdraw an aliquot from
a dissolution tester at a pre-programmed time. The sample is
measured and dispensed through a UV flow cell and/or further
into a collection rack that contains vials or test tubes. The CD
AutoPlus can be programmed to repeat this process multiple
times.
Most other commercial dissolution sampling systems use
peristaltic pump movement of samples into a collector or
through a UV flow cell. The CD AutoPlus avoids the volumetric
inconsistency and high maintenance of the peristaltic pump
and provides an inert environment to minimize drug
absorption.
The AutoFill™ is an automated sample collector designed for
seamless integration with the CD AutoPlus. The AutoFill
includes sample collection capability from eight sources, home
port arrays for wash and waste, all-inert tubing and dispense
probes, and reduced tubing lengths to minimize rinse volume
and save time. Collection racks include 16 x 100 mm test
tubes for UV, 13 x 100 test tubes for UV, 12 x 32 vials for
HPLC.
Section B – CD AutoPlus Introduction
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Definitions:
AutoMag™
An automated mechanism that can be installed on the CD14
Tester to automate raising and lowering of the sample probes
and digital temperature probes (DTPs).
Detect
Determine a sample's absorbance.
Dilute
To collect a solute and a solvent in the same container with
the purpose of reducing its concentration.
Dispense
The pushing out of material from the syringe by the syringe
plunger.
DissoScan™
The autosampler with one 3-way solenoid valve per syringe to
direct fluid flow. The DissoScan provides 2 fluid lines (A and
D).
Load
The drawing of material into the syringe by the syringe
plunger.
Maximizer™
The autosampler with four 4-way solenoid valves per syringe
to direct fluid flow. The Maximizer provides 4 fluid lines (A, B,
C, and D).
Method
The parameters that are entered into the instrument that
determine the operation and steps that are to be accomplished
for a given test.
Occurrence
The dictated time at which a function is performed.
Prime
To fill sample lines with media.
Rack
The vial/test tube holder that fits on the AutoFill.
Recurrence
The dictated time at which a function repeats.
Section B – CD AutoPlus Introduction
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Rinse
The clearing out of old media from tubing with the target
media.
Solenoid Valve
The device that controls flow direction.
Transfer
The moving of liquid from a source to a destination.
Wash
The clearing out of old media from tubing with blank or wash
media.
Section B – CD AutoPlus Introduction
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Figure B-1: CD AutoPlus/AutoFill Identification
AutoFill
Collector
CD AutoPlus
Autosampler
Interchangeable
rack
Dispense head
Tray handle
Touchscreen
Power switch
Autosampler handle
Syringes
Section B – CD AutoPlus Introduction
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Figure B-2: Identification of the CD AutoPlus Fluidics
Section C – Regulatory and Safety
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Section C – Regulatory and Safety
Regulatory Compliance
Teledyne Hanson, a business unit of Teledyne Instruments,
Inc. hereby certifies that this product, including hardware and
firmware, was designed, evaluated, validated, inspected, and
tested to approved specified quality requirements of Teledyne
Hanson in conformance with current USP, EP, JP, and other
international standards (India and Korea).
Canadian Emissions Notice
This digital apparatus does not exceed the Class A limits for
radio noise emissions from digital apparatus set forth in the
Radio Interference Regulations of the Canadian Department of
Communications.
Le présent appareil numérique n’émet pas de bruits
radioélectriques dépassant les limites applicables aux
appareils numériques de la classe A prescrites dans les
réglements sur le brouillage radioélectrique édictés par le
Ministère des Communications du Canada.
CD14 Tester General Safety Considerations
This equipment contains moving parts, which have the
potential to pinch or jam.
The installation category (overvoltage category) for this
instrument is Level II. The Level II category pertains to
equipment that receives its electrical power from a local level,
such as an electrical wall outlet.
This instrument must be connected to a grounded electrical
outlet.
Warning: Never work on the electrical components in the
system while there is power to the unit. Disconnect power
before servicing the instrument.
Never insert items into openings or vent holes while the unit is
connected to power.
Review all safety and environmental precautions pertaining to
any chemicals that are to be used in conjunction with this
equipment.
Section C – Regulatory and Safety
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CD14 Tester Safety Considerations
For indoor use only
Maximum altitude up to 2,000 meters
Environmental operating temperature 5 °C to 40 °C
Operating relative humidity 80% for temperatures up to
31 °C, decreasing linearly to 50% relative humidity at
40 °C
Mains supply ratings 100 - 240 V~, 50 - 60 Hz, 15 A for
the heater and 1.5 A for the 24 V power supply.
Mains supply voltage fluctuations not to exceed ± 10%
of the nominal voltage
Installation Category II (overvoltage categories)
Pollution Degree 2
Please note potential pinch hazards described below.
See the installation section for lifting instructions.
Additional hazards may exist if the equipment is not
operated according to the instructions in the user
guide.
Section C – Regulatory and Safety
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Safety Symbols
The following safety symbols are used on the instruments and
throughout this manual.
Symbol Definition
General warning of potential damage or
danger from a variety of sources.
Electric shock warning: disconnect power
before servicing instrument.
Hot surface warning: internal components
may be hot after covers are removed.
Pinch hazard: keep hands and fingers clear.
Tip hazard: follow the Moving and Storage
instructions to prevent unit from tipping.
Heavy object warning: follow the Moving and
Storage instructions to prevent injury.
Electrical grounding connection.
CD14 Tester Warning Locations
System warnings on the mast –
Service warnings on the heater –
Section C – Regulatory and Safety
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CD AutoPlus General Safety Considerations
The installation category (overvoltage category) for this
instrument is Level II. The Level II category pertains to
equipment that receives its electrical power from a local level,
such as an electrical wall outlet.
This instrument must be connected to a grounded electrical
outlet. If condensation forms on or inside the AutoFill collector,
allow it to dry thoroughly before connecting to a power source.
Never work on the electrical components in the system while
there is power to the unit.
Warning: Disconnect power before servicing the instrument.
Review all safety and environmental precautions pertaining to
any chemicals that are to be used in conjunction with this
equipment.
CD AutoPlus CSA Safety Considerations
For indoor use only
Maximum altitude up to 2,000 meters
Environmental operating temperature 5 to 40 °C
Operating relative humidity 80% for temperatures up
to 31 °C, decreasing linearly to 50% relative humidity
at 40 °C
Mains supply ratings 100 – 240 V~, 50 – 60 Hz, 1.5 A
Mains supply voltage fluctuations not to exceed
±10% of the nominal voltage
Installation Category II (overvoltage categories)
Pollution Degree 2
See the maintenance section (Moving and Storage)
before moving the equipment.
Please note potential pinch hazards per the diagram
below (Figure C-1).
Additional hazards may exist if the equipment is not
used correctly per the user guide.
Section C – Regulatory and Safety
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Figure C-1: CD AutoPlus/AutoFill Potential Pinch Hazards
Between cap and
vials/tubes
Base of moving dispense
head
Under removable
drip tray
Table of contents
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