Teledyne VISION G2 CLASSIC 6 User manual

VISION
®
G2 CLASSIC 6
™
AND ELITE 8
™
DISSOLUTION TESTERS
USER GUIDE
74-108-800-Rev. H—12 June 2019

Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 1 of 158
About Teledyne Hanson Research
Teledyne Hanson Research, 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
Research (THR) 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 Research
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 Research
9810 Variel Avenue
Chatsworth, CA 91311, USA
Phone: [phone]
www.teledynehanson.com

Sales and Support
Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 2 of 158
Congratulations on your purchase of the Teledyne Hanson Research Vision G2
dissolution tester. While we are certain you will enjoy this new product, 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: [phone]
Teledyne Hanson Research
9810 Variel Avenue
Chatsworth, CA 91311, USA

Revision History
Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 3 of 158
Document Revision History
To confirm that you have received the latest version of this user
guide, contact Teledyne Hanson Research Technical Support.
REVISION DATE DESCRIPTION
A 12 Dec 2011 Initial release.
B 09 May 2012 Correction to 4.10.4
C 29 Oct 2012
Improved priming information.
Added information on how to drain the tester.
Added Appendix A with common operator
errors.
Added Appendix B on basic network
configurations.
Added Appendix C on Waters Transfer
Module.
Improved information on archiving and
checksums for protocols.
D 01 Jul 2013
Added leveling procedure to installation.
Added ADD cover for Vision to vessel
covers.
Corrected vessel cover names.
Added information on new Probe Error
message and --.--throughout User Guide.
Added information on firmware updates
when booting up instrument.
E 20 May 2014
Added Quick Start test.
Added Appendix D (reports).
Updated new features for firmware update
ver. 2.20.
F 13 Aug 2014 Added Event Library Appendix (E) and
information.
G 06 Nov 2014 Added Indefinite Pause feature.
H 12 June 2019 Added three-tier security. Updated document
to Teledyne format.

Table of Contents
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Table of Contents
INTRODUCTION..............................................................................................................................7
DEFINITIONS...........................................................................................................................................7
FEATURES.............................................................................................................................................10
VISIONG2TESTERIDENTIFICATION...........................................................................................................11
LEARNINGTHEINTERFACE........................................................................................................................13
REGULATORYANDSAFETY............................................................................................................22
GENERALSAFETYCONSIDERATIONS...........................................................................................................22
CSASAFETYCONSIDERATIONS.................................................................................................................22
CANADIANEMISSIONSNOTICE.................................................................................................................23
INSTALLATION..............................................................................................................................24
LOCATION.............................................................................................................................................24
UNPACKINGANDINSPECTION...................................................................................................................25
ELECTRICALCONNECTIONS.......................................................................................................................28
VISIONHEATERINSTALLATION..................................................................................................................29
PRIMINGTHEWATERBATH......................................................................................................................31
DRAININGTHEWATERBATH(NOTREQUIREDFORINSTALLATION)....................................................................34
GUIDELINESFORCLEANINGTHEWATERBATH..............................................................................................35
VERIFICATIONOFMANUALCONTROLS.......................................................................................................36
VISIONTESTERCOMMUNICATIONCONNECTIONS.........................................................................................36
LIQUIDLINECONNECTIONS......................................................................................................................41
SECURITY..............................................................................................................................................41
DRIVEHEADMOVEMENT(ELITE8ONLY)...................................................................................................46
PADDLEANDBASKETINSTALLATION...........................................................................................................46
VESSELCOVERINSTALLATION...................................................................................................................47
OPERATION..................................................................................................................................51
DIAGNOSTICS........................................................................................................................................51
INFORMATION.......................................................................................................................................52
DISPLAY...............................................................................................................................................56
CONFIGURATION....................................................................................................................................57
TIME...................................................................................................................................................64
TOOLS.................................................................................................................................................70
PROTOCOLS..........................................................................................................................................76
HOWTOPROGRAMAPROTOCOL..............................................................................................................96
DISSOLUTIONTESTING................................................................................................................101
TESTMENU........................................................................................................................................101
HOWTOUSETHEQUICKSTART..............................................................................................................103
HOWTOSTARTATEST..........................................................................................................................106
MANUALSTAGGEREDSTARTWITHVISIONG2TESTER(S)............................................................................109
MANUALSIMULTANEOUSSTARTWITHVISIONG2TESTER(S).......................................................................112
MANUAL(OR3RDPARTYAUTOSAMPLING)USINGAUTOMAGWITHDIGITALTEMPERATUREPROBES(DTPS).......115
SMALLVOLUMEVESSELS.......................................................................................................................118
IMMERSIONCELL.................................................................................................................................119

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Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 5 of 158
MAINTENANCE...........................................................................................................................120
SCHEDULEDMAINTENANCEOVERVIEW....................................................................................................120
O‐RINGINSPECTIONANDREPLACEMENT..................................................................................................121
BELTREPLACEMENT.............................................................................................................................121
HEATERANDTEMPERATUREPROBEADJUSTMENT......................................................................................122
SPINDLESHAFTHEIGHTADJUSTMENT......................................................................................................123
MOVINGANDSTORAGE........................................................................................................................123
TROUBLESHOOTING...................................................................................................................124
CONTACTINGTELEDYNEHANSONRESEARCHFORTECHNICALSUPPORT..........................................................124
ELECTRICALTROUBLESHOOTING..............................................................................................................125
MECHANICALTROUBLESHOOTING...........................................................................................................126
HEATERTROUBLESHOOTING..................................................................................................................127
AUTOMAG/SUPERMAGTROUBLESHOOTING............................................................................................128
SERIAL(VALIDATION)PRINTERTROUBLESHOOTING....................................................................................129
SERIAL(VALIDATION)PRINTERSELF‐TEST.................................................................................................129
NETWORKPRINTERTROUBLESHOOTING...................................................................................................130
SPECIFICATIONS..........................................................................................................................131
VISIONG2CLASSIC6SPECIFICATIONS.....................................................................................................131
VISIONG2ELITE8SPECIFICATIONS.........................................................................................................131
VISIONG2HEATERSPECIFICATIONS........................................................................................................132
VISIONG2DISSOLUTIONTESTERGENERALSPECIFICATIONS.........................................................................133
WETTEDMATERIALS............................................................................................................................134
GENERALWARRANTY.................................................................................................................135
APPENDIXA:ERRORS.................................................................................................................136
VISIONERRORS...................................................................................................................................136
VISIONTESTERERRORS.........................................................................................................................139
VISIONHEATERERRORS........................................................................................................................140
APPENDIXB:NETWORKING........................................................................................................141
NETWORKS.........................................................................................................................................141
ISOLATEDNETWORKS...........................................................................................................................141
CONNECTINGTOAGILENTCHEMSTATIONSYSTEMS....................................................................................142
CORPORATENETWORKS........................................................................................................................143
APPENDIXC:WORKINGWITHAWATERSALLIANCEDISSOLUTIONSYSTEM.................................144
FIRMWAREREQUIREMENTS...................................................................................................................144
INSTALLATIONANDCONFIGURATION........................................................................................................144
OPERATINGTHESYSTEM.......................................................................................................................144
LIMITATIONS.......................................................................................................................................145
APPENDIXD:REPORTS................................................................................................................146
APPENDIXE:EVENTLIBRARIES....................................................................................................154
HOWEVENTLIBRARIESWORK................................................................................................................154
CREATINGABASICEVENTLIBRARY..........................................................................................................155

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USINGANEVENTLIBRARY.....................................................................................................................156
EXAMPLESOFHOWTOUSEANEVENTLIBRARY.........................................................................................157

Figures and Diagrams
FIGUREA‐1IDENTIFICATION:VISIONG2CLASSIC6TESTER...............................................................................11
FIGUREA‐2IDENTIFICATION:VISIONG2ELITE8TESTER...................................................................................12
FIG.C‐1REMOVELOCKINGBOLTS................................................................................................................26
FIG.C‐2ELITE8RELEASELEVER...................................................................................................................26
FIG.C‐3BUBBLELEVELONALEVELEDTESTER.................................................................................................27
FIG.C‐4VISIONG2(CLASSIC6ANDELITE8)BACKPANELPORTS.......................................................................28
FIG.C‐5VISIONHEATERBACKPANELPORTS..................................................................................................28
FIG.C‐6CLASSIC6BATHTOHEATERTUBINGCONNECTION...............................................................................30
FIG.C‐7ELITE8BATHTOHEATERTUBINGCONNECTION..................................................................................30
FIG.C‐8FILLWATERBATHTOAPPROPRIATELINEONSTICKER..............................................................................31
FIG.C‐9INSERTTHETUBINGFROMTHESYRINGEINTOTHEFITTING......................................................................32
FIG.C‐10DRAINPLUGINTHEBATHOUTPUTFITTING(VIEWEDFROMABOVE)........................................................34
FIG.C‐11DRAINPLUGINBATHOUTPUTFITTING(VIEWEDFROMTHESIDE)...........................................................34
FIG.C‐12LIQUIDLINECONNECTIONS............................................................................................................41
FIG.C‐13SHAFTCLAMPANDKEYINPOSITION................................................................................................47
FIG.C‐14EASI‐LOCKCOVER74‐104‐151.....................................................................................................47
FIG.C‐15ADDCOVERFORVISION74‐104‐152............................................................................................48
FIG.C‐16EASI‐LOCKADDCSCOVER74‐107‐013........................................................................................49
FIG.C‐17EASI‐LOCKCSCOVER74‐107‐012................................................................................................50
FIG.D‐1AUTOMAGCALIBRATIONTOOLINPLACE...........................................................................................71
FIG.D‐2SUMMARYOFUSBTRANSFERFUNCTIONS.........................................................................................79
TABLEH‐1WETTEDMATERIALS.................................................................................................................134

Introduction
Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 7 of 158
Introduction
Teledyne Hanson Research Vision® "G2" (second generation)
dissolution instruments are designed for the 21st century, with
state-of-the-art electronics, mechanics, and quality throughout.
these systems are power-packed for the demands of today's
pharmaceutical scientist, from research, to formulations, to
quality assurance. We have applied 60 years of innovation and
expertise to the design and manufacture of these quality test
systems.
At Teledyne Hanson Research, we combine art with science
and engineering. We apply elegant design and instrument
ergonomics to the rigors and everyday challenges of scientific
investigation, research, and analysis. Every dissolution test
operator requirement is evaluated and simplified for ease of use
and fast results. Our test systems are designed for the
dissolution laboratory with a tight schedule and a heavy
workload.
Definitions
ADD™ Cover
A vessel cover with a sealed chamber for the dosage. The
chamber protects the dosage from environmental conditions
and can be triggered by an AutoMag™ to automatically start a
test.
AutoFill™
The redesigned sample collection instrument built in to the top
of the Vision AutoPlus.
AutoMag™
An automated mechanism that can be installed on the Vision
Elite 8 dissolution tester to automate raising and lowering of the
sample probes and Digital Temperature Probes (DTPs).
Classic 6™
A rugged compact six-position dissolution test station with a
unique two-across, three-deep design. The workhorse unit ideal
for manual test routines, space-limited laboratories, and budget-
minded programs.
Detect
Determine a sample's absorbance.

Introduction
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DissoScan™
The autosampler with one 3-way solenoid valve per syringe to
direct fluid flow. The DissoScan provides 2 fluid lines (A and D).
One tester can be connected to a DissoScan.
Easi-Lock™
The system used by Vision vessels that allows them to be
locked into place. It allows for consistent centering and prevents
chipping of the edges of the vessel.
Elite 8™
An eight-position high-performance machine built for
automation and extended applications.
Fixed Probe
A stationary vessel mount sampling probe mounted to the
vessel cover for connection to an automated sampler.
Maximizer™
The autosampler with 4-way solenoid valves per syringe to
direct fluid flow. The Maximizer provides 4 fluid lines (A, B, C,
and D). Up to 3 testers, or 2 testers with media replace can be
connected to a Maximizer.
Occurrence
The dictated time at which a function is performed.
Protocol
The parameters that are entered into the instrument that
determine the operation and steps that are to be accomplished
for a given test.
Recurrence
The dictated time at which a function repeats.
Retrieval Reservoir
The Retrieval Reservoir is an optional accessory placed on the
AutoFill. This accessory enables the AutoPlus to return rinse
volume back to vessel(s) in multiple tester applications. This
method will accommodate one or two testers with media replace
or three testers without media replace.
Shaft Clamp
The knob at the top of the spindle shaft. It is used to easily
manipulate or remove the spindle shaft.

Introduction
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Spindle Shaft
The shaft that passes through the drive head of a Vision
dissolution tester. There are 6 spindle shafts on the Classic 6
and 8 on the Elite 8. Basket shafts, paddles, and other
apparatus can be screwed into the spindle shafts.
SuperMag™
An automated mechanism capable of accommodating 1-liter,
Small Volume (SV), and Chinese Small Volume (CSV) vessels
that can be installed on the Vision Elite 8 dissolution tester to
automate raising and lowering of the sample probes and Digital
Temperature Probes (DTPs).
Vessel Rings
The rings that snap into the Vision dissolution tester vessel
plates. The rings hold the Vision Easi-Lock vessels securely in
place.
Vision® AutoFilter™
A programmable filter changing instrument which uses 25 mm
in-line syringe filters.
Vision® AutoPlus™
The redesigned Teledyne Hanson autosampler series (either
Maximizer or DissoScan) with stepper motor driven syringes.
Vision® G2
Teledyne Hanson Vision® “G2” dissolution instruments
represent a significant upgrade from the original Vision testers
introduced in 2008. Our new G2 operating platform includes full-
color touchscreens for instrument programming, extensive
programming menus, up to 100 operating protocols, a security
configuration which supports 21CFR11-compliance, a
convenient flash drive for instrument uploads and downloads,
and 32-bit digital technology.
Waters Transfer Module
The Waters Transfer Module is a syringe-based sampling
system connected to a Waters HPLC. It allows for full
automation of dissolution systems with HPLC analysis.

Introduction
Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 10 of 158
Features
The new Vision G2 dissolution testers take the next step in
dissolution testing with a streamlined new design and increased
functionality. Here are some of the new features
Classic 6 Elite 8 Standard Features
 Fixed drive head
 6 Precision drive spindles with spindle shafts
 6-Position Easi-Lock™ vessel plate
 Compact footprint (2 across & 3 deep)
 Easi-Lift™ moveable drive head with multi-lock positions
 8 Precision drive spindles with spindle shafts (use 6, 7, or 8)
 8-Position Easi-Lock™ vessel plate (use 6, 7, or 8 vessels)
 Standard footprint (4 across & 2 deep)
 Automation-ready (with optional AutoMag™ & SuperMag™)
  Precision control for speed 25-250 rpm, temperature 25-55 ºC
  Elegant, ergonomic design with workhorse performance
  Highest quality components and engineering
  Minimal user adjustments for easy setup and go
  Independent Vision® heater system
  Rugged molded waterbath with fast heat-up & low level drain
  Digital temperature probe (1) for use in bath and vessels
  Full color touchscreen with intuitive menus and programming
  Up to 100 protocols (create, manage and save routines)
  Upload & download programs with flash drive
  Electronics and firmware include 32-bit digital technology
  Print to both serial and PostScript network printers
  Alarms for sampling, maintenance and calibration
  ISO 9001 quality certified
  Security system supports 21 CFR Part 11 compliance
  USP / FDA / ASTM / EP / JP compliant
  CE / CSA / RoHS compliant, includes Earth-friendly packing

Introduction
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Vision G2 Tester Identification
Figure A-1 Identification: Vision G2 Classic 6 Tester
Shaft clamp
Touchscreen
Spindle shaft
Power switch
Vision heater

Introduction
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Figure A-2 Identification: Vision G2 Elite 8 Tester
Shaft clamp
Power switch
AutoMag
Vision
heater
Touchscreen
Drive
head
handle
Spindle
shaft

Introduction
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Learning the Interface
The Vision G2 dissolution tester software was designed to be
intuitive and easy to use. A user is able to interact and program
the unit using the touchscreen interface. The touchscreen can
be used with fingers or with a stylus. The interface has the
following forms of input:
Buttons: In order to use a button, touch it with your finger or a
stylus. Buttons may appear as having text or as icons.
Sliders: In order to use a slider, place a finger on the slider
button and slide the finger right or left to place the slider in the
desired position. Sliders are found for display and audio settings
on the unit.
Text Keypad: Text keypads are used for text entry into the unit.
Text fields are typically restricted to 25 characters.
To enter a letter, touch the button for the letter. To delete a
letter, use the del button.
To finish entering text, touch the OK button.

Introduction
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To cancel out of the screen, touch the ESC button.
NOTE: Touching the (X) in the input line clears in the whole line.
Numeric Keypad: The numeric keypads are used for numeric
entry into the unit.
Unlike the text keypads, numeric keypads often have limits or
specific formats which must be observed when entering
information. These limits and formats are stated in the upper left
corner of the screen below the field name. For example, the IP
address of the Vision tester must be entered in a numerical
format as follows: xxx.xxx.xxx.xxx. If the wrong format is
entered, the Vision tester will produce an error sound and reset
the field so the correct value can be entered.
NOTE: Some numeric keypads have preset entry buttons for
commonly used values, such as the instrument's speed and
temperature.

Introduction
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Calendar
When setting dates, a calendar screen will be displayed. Touch
the arrows located at the bottom of the calendar screen to select
the month. Touch the day of the date displayed to select that
date.
Tab buttons
The tab buttons are located on the left side of the screen and
allow access to different parts of a section of the software. For
example, the Edit Alarms screen has 4 tabs that allow the
editing of the Preheat Alarm, Sampling Alarms, User Alarms,
and Calibration Alarms.
Fields
When touched, these will allow the user to edit the settings for
that field. Depending on the field, the values will be toggled, or
a data entry screen (text keypad, numeric keypad, calendar) will
appear, allowing the user to edit the data accordingly.

Introduction
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Send button
The Send button allows the user to print the displayed logs to
the printer or upload them to a USB flash drive. This is a
common button on many of the screens of the Vision tester.
NOTE: For ease of reading, it is recommended to open logs in
a word processor. Text editors (e.g., Windows Notepad) may
place all the information on one line.
Exit button
The Exit button allows the user to return to the main menu. This
button is typically located in the lower right corner of the screen.

Introduction
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After the initialization sequence completes, the unit remains at
the home screen. The home screen displays the motor speed
(rpm), motor speed set point, temperature, temperature set
point, elapsed test time, and a countdown until the next event.
If no test is running, the times will be listed as 0:0000. The motor
speed and temperature are displayed on the left side of the
screen.
To adjust the motor speed, touch the RPM SETPOINT field and
a numeric keypad will appear.
Enter the desired motor speed and touch OK. This will start the
motor spinning at the desired speed. Preset buttons are
available for 50, 75, and 100 rpm. The OFF button will stop the
motor. The Quick Start button will hold the value for a quick test.
Touch the Elapsed Time field to set a test length for a Quick
Start test. For starting a quick test, see “How to Use Quick Start”
section.

Introduction
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NOTE: If a Quick Start speed is not set, the Elapsed Time field
will not respond when touched.
To adjust the temperature, touch the current temperature on the
home screen and a numeric keypad will appear. If there is a
problem with the external temperature probe, “Probe Error” will
be displayed.
Enter the desired temperature and touch Ok. The pump will start
and the temperature should begin to rise. There are preset
buttons for 32 °C and 37 °C. The PUMP button starts the pump
if it is off, or stops it if it is running. The temperature will
automatically be set to 0 if the pump is turned off. The OFF
button turns off the pump and sets the temperature to 0.
NOTE: As a safety feature, manual control of the pump is only
active when the set temperature is 0.

Introduction
Vision G2 Testers User Guide—74-108-800 Rev. H—12 June 2019 19 of 158
Touching the Vessels button brings up the Vessels screen,
which displays the current temperature in the vessels. On the
left side of the Vessels screen, you have the option of raising or
lowering the probes using the Raise or Lower arrows (if
AutoMag or SuperMag is installed), and/or printing the vessel
temperatures using the Print button. If there is an error with one
of the vessel temperature probes, “--.--” will be displayed in
place of the temperature.
The Start button is located on the bottom right of the home
screen and is used for starting tests. The time and date of the
system are displayed at the bottom center of the screen.