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Section C – Regulatory and Safety

CD14 Tester & CD AutoPlus Autosampler User Guide—75-108-800 Rev. B—31 May 2021

19 of 130

EAR99 technology subject to restrictions on cover page.

Figure C-1: CD AutoPlus/AutoFill Potential Pinch Hazards

Between cap and
vials/tubes

Base of moving dispense
head

Under removable
drip tray

Содержание CD14

Страница 1: ...ined herein is classified as EAR99 under U S Export Administration Regulations Export re export or diversion contrary to U S law is prohibited CD14 COMPARATIVE DISSOLUTION TESTER AND CD AUTOPLUS AUTOSAMPLER USER GUIDE 75 108 800 Rev B 31 May 2021 ...

Страница 2: ... 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 v...

Страница 3: ...ler 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 hansontechsupport teledyne com Email hansonsales teledyne com Phon...

Страница 4: ...ubject to restrictions on cover page 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 ...

Страница 5: ...TIONS 17 CD AUTOPLUS GENERAL SAFETY CONSIDERATIONS 18 CD AUTOPLUS CSA SAFETY CONSIDERATIONS 18 SECTION D TESTER INSTALLATION 20 QUICK START 20 LOCATION 20 ENVIRONMENTAL REQUIREMENTS 20 SPACE REQUIREMENTS 21 ELECTRICAL REQUIREMENTS 21 GENERAL UNPACKING AND INSTALLATION 22 UNPACKING THE CD14 TESTER 22 ATTACH LIFTING HANDLES 23 REMOVE COUNTER WEIGHT SHIPPING BOLTS 24 MOVING THE UNIT 25 LIFTING THE UN...

Страница 6: ...AY 71 TIME ALARMS 72 TOOLS BUTTON 77 SECTION G DISSOLUTION TESTING 81 METHODS 81 METHOD SCREEN 83 HOW TO START A TEST 90 MANUAL STAGGERED START WITH CD14 TESTER 94 SECTION H CD14 TESTER MAINTENANCE 97 SCHEDULED MAINTENANCE OVERVIEW 97 O RING INSPECTION AND REPLACEMENT 98 BELT REPLACEMENT 98 DRAINING THE WATERBATH 99 GUIDELINES FOR CLEANING THE WATERBATH 99 ADJUSTMENTS AND CALIBRATION 99 SPINDLE SH...

Страница 7: ...HEATER SPECIFICATIONS 119 CD14 TESTER GENERAL SPECIFICATIONS 120 CD AUTOPLUS SPECIFICATIONS 120 AUTOFILL SPECIFICATIONS 121 CD AUTOPLUS AUTOFILL GENERAL SPECIFICATIONS 122 WETTED MATERIALS 123 SECTION L GENERAL WARRANTY 125 APPENDIX A ERRORS 126 CD14 TESTER ERRORS 126 Figures and Diagrams FIGURE A 1 IDENTIFICATION OF THE CD14 TESTER 9 FIGURE B 1 CD AUTOPLUS AUTOFILL IDENTIFICATION 13 FIGURE B 2 ID...

Страница 8: ...st 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 man...

Страница 9: ...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 comp...

Страница 10: ... CD14 Tester CD AutoPlus Autosampler User Guide 75 108 800 Rev B 31 May 2021 9 of 130 EAR99 technology subject to restrictions on cover page CD14 Comparative Dissolution Tester Identification Figure A 1 Identification of the CD14 Tester ...

Страница 11: ...ssolution 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 avo...

Страница 12: ...rom 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 paramet...

Страница 13: ... 130 EAR99 technology subject to restrictions on cover page 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 ...

Страница 14: ...75 108 800 Rev B 31 May 2021 13 of 130 EAR99 technology subject to restrictions on cover page Figure B 1 CD AutoPlus AutoFill Identification AutoFill Collector CD AutoPlus Autosampler Interchangeable rack Dispense head Tray handle Touchscreen Power switch Autosampler handle Syringes ...

Страница 15: ...utoPlus Introduction CD14 Tester CD AutoPlus Autosampler User Guide 75 108 800 Rev B 31 May 2021 14 of 130 EAR99 technology subject to restrictions on cover page Figure B 2 Identification of the CD AutoPlus Fluidics ...

Страница 16: ...reil 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 overvolt...

Страница 17: ...ty 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 sect...

Страница 18: ...al 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 Ele...

Страница 19: ...e 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 u...

Страница 20: ... Autosampler User Guide 75 108 800 Rev B 31 May 2021 19 of 130 EAR99 technology subject to restrictions on cover page Figure C 1 CD AutoPlus AutoFill Potential Pinch Hazards Between cap and vials tubes Base of moving dispense head Under removable drip tray ...

Страница 21: ... powers up then turn power off 7 Make bath tubing connections and fill bath to just above the ports on the back of the bath Check for leaks 8 Turn pump on and prime with priming syringe if needed Check for leaks and that the unit is pumping bath water Turn pump off 9 Place temperature probe in bath and set temperature to 25 C and see that the bath temperature goes up 10 Set up and configure firmwa...

Страница 22: ...eight including water of each machine as stated in the specifications section The CD14 Tester should be placed in the center of the autosamplers if used Electrical Requirements Each CD14 dissolution tester requires two grounded outlets within 3 meters 9 ft of the location of the system one for the dissolution unit and one for the heater box The CD14 Testers are available in one configuration 100 V...

Страница 23: ...cess to the counterweight lock screws It s best to do this as close to the final installation site as possible Unpacking the CD14 Tester 1 Prior to unpacking note any damage to the container If the container is damaged contact the shipping company and Teledyne Hanson before proceeding 2 Remove the straps and open the top of the cardboard box 3 Remove any inside packaging and as many small items as...

Страница 24: ...he oval handle inserts in the ends of the oval shaped openings of the bottom legs 2 The inserts are retained in the ends of the legs with a single screw from under the legs NOTE The inserts will be removed from the legs once the CD14 Tester is located on a bench 3 Screw the handles into the oval handle inserts 4 Important Verify oval handle inserts will not pull out of the legs by pulling on the h...

Страница 25: ...the cable track and then carefully pull it up and away from the mast to gain access to the 2 counterweight lock screws 2 Remove the 2 lock screws with the provided hex wrench 3 Make sure the counterweight cable is properly seated in the groove of the pulley above The counterweight can be lifted enough to provide slack in the cable if this is needed 4 Replace the mast cover 5 Remove the other mast ...

Страница 26: ...people each able to lift 55 lbs should be used to lift the unit from floor level to the surface of the bench The following steps outline a process that should minimize the amount of time and effort required to lift the unit For reference the unit weighs approximately 260 lbs 118 kg Note For illustrative purposes the following photos contain an incomplete CD14 Tester Safety First All who are liftin...

Страница 27: ...subject to restrictions on cover page 4 The two side feet are placed on the bench first 5 At this point the person at position 4 at the rear corner where the instrument foot is now on the bench will move to position 5 replacing that person originally there who has now backed away 6 The foot under the mast slides onto the bench 5 4 1 ...

Страница 28: ...er User Guide 75 108 800 Rev B 31 May 2021 27 of 130 EAR99 technology subject to restrictions on cover page 7 The unit continues to be slid onto the bench so the last rear foot is supported by the bench In the process the unit is turned to a forward facing position ...

Страница 29: ...les and oval inserts 5 32 Allen hex wrench from the frame 10 Install the two front frame end caps by lightly tapping them in place with a hammer Level the Unit 1 Position the unit on the table to allow for other equipment that may need to be installed next to it e g autosamplers 2 The height of the unit has been factory set to within 3 7 3 9 in 9 4 9 9 cm from the bench top to the underside of the...

Страница 30: ...ft to right and along the left and right outside edges of the plate to check the Y axis front to back levelness 5 To level raise the two back feet out of the way and then adjust the two front feet and the single foot under the mast to achieve a maximum of 0 2 degrees in both directions Once set lower the two back feet that were raised prior to leveling down to where they just touch the bench top F...

Страница 31: ...ver page Heater Assembly 1 Match the labeled ends of the tubing with the labeled locations on the back of the heater assembly 2 Make the connections and route the tubing as shown 3 Insert the power brick in the storage area shown 4 Route the 24VDC power cable as shown and plug the connector into the back of the heater 5 Tie wrap the cable to the tubing as shown ...

Страница 32: ...iewed from the front of the unit The cable bundle will extend out to the front of the unit when the connections are made to the heater then fold back with the loop to the left when the heater is pushed all the way back into position NOTE If samplers host and or serial printer cable are intended to be part of the installation these cables can be tie wrapped at this time to the cable bundle to allow...

Страница 33: ...Holding the heater in front of the unit guide the blue water circulation tubes and power brick power cord under the bath support plate and on top of the cable bundle that comes from the back of the unit and rest the back end of the heater on the bench 4 While still supporting the front of the heater make the cable connections from the cable bundle to the rear of the heater ...

Страница 34: ...he vessel plate 6 After all connections have been made to the heater gently slide the heater box all the way back as far as it will go The tubes may need some guidance as this is done so they go straight back and are over the cable bundle 7 With the drive plate assembly raised all the way up reach over the vessel plate if there is no clearance on the sides to connect both sets of water circulation...

Страница 35: ...Section D Tester Installation CD14 Tester CD AutoPlus Autosampler User Guide 75 108 800 Rev B 31 May 2021 34 of 130 EAR99 technology subject to restrictions on cover page ...

Страница 36: ...to restrictions on cover page 8 Plug in the network connection if applicable to the connector located on the lower end of the mast 9 With the drive head power switch in the off O position plug in the power brick power cord to a power source 10 With the heater power switch in the off O position plug in the heater power cord to a power source ...

Страница 37: ...Doing so may result in damage to the heater 1 Verify that the waterbath is adjusted all the way up by turning the four bath support plate adjustment knobs clockwise until they can no longer be turned 2 The use of DI deionized water is highly recommended for filling the bath 3 If the vessels have not been installed fill through a vessel hole in the vessel plate to the water level indicated on the l...

Страница 38: ...ated on the bath 2 At the display touch the center of the black ribbon This will bring up a keypad window 3 At the keypad window touch the Pump ON button Any additional air that blows out into the bath will stop shortly Note If water doesn t start flowing when the pump is started then shut the pump off at the displayed keypad inject water into the two bottom left and right ports within the bath a ...

Страница 39: ...ng any of the blue buttons or a temperature can be entered at the keypad to the left Touch Enter to start 5 Check for leaks a second time Tester Installation is Complete The CD14 dissolution tester is now ready for adding desired accessories and proceeding with normal operations The next section describes the installation of the accessory autosamplers If manual sampling is going to be used skip to...

Страница 40: ... Requirements The bench should be at least 60 cm 24 in deep and clearance above the units of at least 82cm 32 in The bench should be level and flat The bench should be capable of supporting weight given in the specifications section For additional pieces of equipment e g UV Vis spectrophotometers etc see the user guides for the respective pieces of equipment Electrical Requirements Each CD AutoPlu...

Страница 41: ... Place each CD AutoPlus on the bench a Each CD AutoPlus should be placed in a manner to allow access to the back of the autosampler until the installation is completed Once the installation is complete the instrument can be placed in its final position b Place each AutoFill on top of its corresponding CD AutoPlus with the tray for the rack toward the front of the unit c Place a collection rack on ...

Страница 42: ...e CD AutoPlus flat side facing the unit the connector is keyed so it will only fit one way Then connect the power supply to the wall outlet 3 Ensure the power switch located on the back of the AutoFill is in the off O position 4 Connect the power supply to the port labeled 24 V Input 3 75 A on the back of the AutoFill flat side facing the user the connector is keyed so it will only fit one way The...

Страница 43: ...cation Connections This section provides instructions on how to make the communication connections between the CD AutoPlus and AutoFill so that the CD AutoPlus can control the AutoFill Figure E 3 CD AutoPlus AutoFill Connections For each sampler collector pair 1 Connect one end of the RS 232 cable to the port labeled Collector on the back of the CD AutoPlus 2 Connect the other end of the RS 232 ca...

Страница 44: ...s should move to the home position and their displays will be illuminated The units may take as long as 30 seconds to reach the home screen If either CD AutoPlus does not power on consult the troubleshooting section of this user guide NOTE If the AutoPlus is turned on before its corresponding AutoFill an error will be generated and the user will be forced to power up the instruments in the correct...

Страница 45: ...age 7 From the CD14 Tester main screen touch the menu button and select the Config option 8 Touch the Setup button and select the Accessories tab 9 Depending on the autosampler type select either the AutoPlus DissoScan or AutoPlus Maximizer for the Sampling Mode 10 Enter the corresponding sampler ID s to be associated with the samplers 11 Press the Return button when done ...

Страница 46: ...s on cover page 12 From the CD14 Tester main screen touch the menu button and select the Time Alarms option 13 Touch the Set Clock toolbar button and adjust the system time and date Touch Return to exit back to the main screen NOTE When a CD AutoPlus is configured in the sampling mode as was done above the CD14 Tester will also set the clocks of both samplers ...

Страница 47: ...hat the syringe drive is functioning properly 1 From the CD AutoPlus Home screen touch anywhere on the screen to enter the menu screen Note Access to the menu screen of the CD AutoPlus is restricted once Security is enabled in the CD14 Tester 2 Once in the menu screen touch the Tools button 3 The Automatic Syringe Control screen will appear 4 Touch the Manual syringe button located at the bottom o...

Страница 48: ...rictions on cover page 5 Touch the Volume field to bring up the numeric keypad 6 On the numeric keypad touch 5 and then OK to enter a volume of 5 0 The Manual Syringe Control screen will reappear 7 Touch the green arrow button located in the center of the display to perform a transfer Ensure that the syringes go down and then return to the home position ...

Страница 49: ...tarting from the screen in the previous step 5 of Verifying Syringe Functions touch the Collector button located at the bottom of the screen The Collector Controller Menu will appear Note the type of rack installed which appears next to the word Rack on the screen Touch the Go to Row button 2 If a 12 x 32 rack is installed enter 21 and touch the OK button If a 13 x 100 or 16 x 100 rack is installe...

Страница 50: ...1 May 2021 49 of 130 EAR99 technology subject to restrictions on cover page 3 Touch the Needles Down button Ensure that the needles lower properly and align with the rack 4 Touch the Initialize button to return the dispense head to the home position 5 Touch the Exit button to return to the menu screen ...

Страница 51: ...k vessels the shaft components and the test unit itself are intended to reduce the need for user adjustments and settings It should not be necessary to adjust the position of the spindle shafts to obtain the proper height spacing between the bottom of the apparatus and the vessel If adjustment is needed refer to the troubleshooting section of this user guide To install paddles or baskets 1 Ensure ...

Страница 52: ...y of the shaft clamp and the key on the spindle itself are at the same level so that they will lock together Figure F 1 Shaft Clamp and Key in Position Vessel Installation 1 Lower the vessel into place in the vessel bushing 2 Rotate until the keys on the vessel slide into the groves on the vessel ring and then rotate the vessel clockwise until it stops Note the witness marks The vessels will only ...

Страница 53: ...de A and B current bath temperature and test status elapsed time next sample time etc NOTE The left side is side A and the right side is side B Manually setting speed and temperature The speed and temperature may be set directly by touching the status speeds and temperature readings Enter the desired speed or temperature using the keypad Program often used values into the blue keys using the Progr...

Страница 54: ... subject to restrictions on cover page Main toolbar The main toolbar gives the user access to the following Methods Select view edit instrument methods Tools Access user tools such as adjusting temperature probe readings and magazine calibration Run Stop Run stop a dissolution method Vessels View print vessel temperatures ...

Страница 55: ...llowing Config View edit instrument configuration labels accessories Security View edit instrument users and security configuration Diagnostics Run instrument diagnostic tasks Display Configure instrument display settings Calibrate touchscreen Time Alarms View edit instrument real time and alarms Info Logs View instrument information such as event logs instrument errors test reports serial numbers...

Страница 56: ... is restricted to user security access 3 Input field Displays the name and value of a field White background signifies that the user may touch the field to edit the value displayed 4 Help icon When touched displays context sensitive help for this particular screen This may involve detailed descriptions and tips for the screen 5 Read only field When grayed user can only view the value of the field ...

Страница 57: ...llows for the configuration of the instrument ID and network communication settings Instrument ID The instrument identification will appear on the header of various printouts This identifies the source instrument of the information The system ID is limited to 25 characters I P Address The internet provider address is a numerical label assigned to each tester communicating through the network Gatew...

Страница 58: ...stScript NOTE Network printers must support PostScript in their firmware Printers that support PostScript through PC software drivers or do not support PostScript will not work Only the Epson serial printer provided by Teledyne Hanson is supported Both network and serial printers may be enabled at the same time Page Format Toggles the paper size between letter and A4 when using a PostScript capabl...

Страница 59: ... white even if this is selected Serial Printer Selected when the Epson serial printer provided by Teledyne Hanson is connected Accessories tab The Accessories tab allows the user to define the accessories installed on the CD14 Tester and accessories connected to the system Sampling Mode How sample aliquots are collected Manual if collected by hand AutoPlus DissoScan or AutoPlus Maximizer if using ...

Страница 60: ... 25 characters in length For example if instead of Method I D the user wanted the field titled Lab Notebook the user would touch the field for Method I D and enter the text Lab Notebook This would change the field name to Lab Notebook in all methods This works the same for the fields in report headers Company Name This is the name of the company that owns the CD14 Tester Department The department ...

Страница 61: ...nt NOTE The previous logo will be overwritten by the new logo Only one logo can be present in the instrument at a time Method Labels tab The Method Labels tab allows for editing the fields of the method labels section Up to 8 label fields are available each having a maximum length of 25 characters The default values are Method Name This field always contains the method name and cannot be changed D...

Страница 62: ...est e g 900 mL Report Headers tab Headers are information which applies to each individual test run rather than a method This tab allows for editing the header field names Up to 8 header fields are available each having a maximum length of 25 characters The default values for headers 1 2 3 and 8 respectively are Report Name The name of the current report This label may be changed but the report na...

Страница 63: ...ons as well as version release history Please follow the instructions included with the kit Security The Security button on the main menu allows the user access to the Security Configuration screen The CD14 Tester can be configured to require users to log in and allows for tracking of any changes made to the method The security system allows for three types of users administrators managers and ope...

Страница 64: ...ber of tries that a wrong password can be entered consecutively before a user is locked out of the instrument A user with security access must unlock a user that has been locked out The range is 1 10 Minimum Password Length The minimum length of a password that will be required of the user when entering a new password or changing an existing one The range is 4 25 Require Complex Password When sele...

Страница 65: ...ecurity is enabled an existing user may use this wizard to enter or change his or her password and fingerprint scan for authentication Passwords and fingerprint scans allow the user to log into and use the instrument when security is enabled Users button This screen allows a user with security settings access to manage instrument users The list of users includes user type and current status active...

Страница 66: ...Methods Allows the ability to edit create import and export methods Security Settings Allows the configuration of security settings adding removing users and adjusting access levels At least one group must have this permission Use Tools Allows access to the Tools menu of the instrument Run Tests Allows the ability to run a test from a method Methods can be viewed and printed by all active users Ed...

Страница 67: ...tionality and test the connections of the configured equipment Failures are shown in red text on the screen The failures of the diagnostics tests are also stored in the error log located in the Info Logs screen from the main menu NOTE For a list of errors and possible causes remedies refer to appendix A of this user guide Information The Info Logs button on the main menu allows access to various s...

Страница 68: ...e firmware version Controller Version Main controller firmware version Spindle Drive A B Version Motor drive firmware versions Temperature Control Version Temperature control firmware version Magazine Board A B Version Magazine board firmware versions Sampler A B Version Autosampler firmware versions Collector A B Version AutoFill collector firmware versions Cumulative Motor A B On Time Cumulative...

Страница 69: ...activity This includes but is not limited to parameter changes user logins running diagnostics changes to settings or editing of methods Test Report Test Report B This log lists all the actions that occurred during the last test The log is transferred to the test history log when a new test starts Errors Log This log lists system errors that occur on the unit This can include communication issues ...

Страница 70: ...edited with proper permission Instrument tab CD14 Instrument This is the serial number for the CD14 Tester itself Heater Control This is the serial number for the heater Serial Printer This is the Epson printer serial number provided by Teledyne Hanson that is connected to the instrument Sampler A B Serial Numbers These are the serial numbers for Sampler A left side and for Sampler B right side Co...

Страница 71: ...serial numbers touch the desired field To edit the group name and icon touch the selected group a second time Service Log screen The Service Log screen is accessed by the Service button of the toolbar Touch the appropriate field to reset the item When resetting any of the counters a confirmation will be requested Calibration Due Date The date of the last calibration of the unit Preventive Maintena...

Страница 72: ...number of tests run Display The Display button on the main menu allows the user to access the Touchscreen Settings screen Brightness Slider Adjust the brightness of the screen by using the slider located next to the brightness symbol Volume Slider Allows the user to increase or decrease the volume of the feedback sounds Calibrate Button This button begins the touchscreen calibration procedure It i...

Страница 73: ...waterbath heats to the bath temperature set point at the specified time and date This allows the tester to be ready for the start of a workday while saving power overnight Bath Temperature This is the temperature that the tester will heat up to The button brings up numeric keypad The range is 25 51 C preset values are 32 37 and 51 C Alarm Date Time The date time the alarm will begin heating the ba...

Страница 74: ... alarm sound The alarm will stop when the user touches OK on the alarm notification pop up On Off Switch Enables disables the user alarms Alarm Number Toggles between the 3 user alarms available Alarm Date Time The date time the alarm will trigger the reminder message Recurrence The method by which the alarm repeats Either never at specific days of the week or at day intervals Alarm Tone The tone ...

Страница 75: ...ssage is displayed on the screen with an alarm sound On Off Switch Enables disables notifications at sampling events Prenotification Time The amount of time before a sample point the alarm begins to sound For example if the user set the alarm to 0 01 the alarm would begin 1 minute before each sample point 0 9 59 in hh mm NOTE If enabled from the method a sampling wizard appears guiding the user wh...

Страница 76: ...Maintenance Type Calibration or preventive maintenance Alarm Date Time The date time the alarm will trigger the reminder message Recurrence The method by which the alarm repeats Either never at specific days of the week or at day intervals Alarm Tone The tone the instrument will play when the alarm triggers The current tone is played when the Play icon is touched Reminder The text which is display...

Страница 77: ... month Jan Dec DD is the day 01 31 and YYYY is the year in the long format 2009 2999 The entry of the format is numerical having the format MMM DD YYYY The System Time format is 24 hour time military time as HH MM SS where HH is the current hour 00 24 MM is the current minute 00 59 and SS is the current second 00 59 NOTE The system clock is powered by a capacitor If the system is left unplugged fo...

Страница 78: ...ability to set temperature probe reading offsets and to calibrate magazine travel Adjust Temperatures Adj Temps tab The instrument temperature probes including those that determine the temperature control and feedback are factory calibrated However each individual probe s reading may be adjusted by changing its offset value Touch the corresponding temperature reading and enter the corrected temper...

Страница 79: ...brate Magazines Cal Mag tab Touch the Cal Mag tab to access the magazine calibration screen NOTE This tab only appears if magazines are selected in the configuration section Magazine Sample Travel This field is the depth at which the Magazine will travel to when the sample button is touched Magazine ADD Travel This field is the distance in mm from the home position to the ADD covers to implement a...

Страница 80: ...n However if they do need to be recalibrated perform the following steps from the Calibrate Magazines screen 1 Calibrate one magazine at a time 2 With middle vessels removed place the calibration block across the center of the middle vessel brackets directly beneath the magazine drive screw 3 In the Calibrate Magazines screen touch the Calibrate button The magazine will move down and touch the blo...

Страница 81: ... on cover page Remote Command screen The Remote Command screen is accessed by touching the Remote button from the toolbar This screen allows the user the ability to enter special commands used for special diagnostics and advanced features Warning The Remote Command screen should only be used when instructed to by Teledyne Hanson Technical Support ...

Страница 82: ...n Testing Methods Methods can be accessed by touching the Methods button on the main screen Methods are a list of parameters and events that are required to perform a dissolution test These parameters can be modified to accommodate the user needs Up to 100 different methods can be stored Recent tab The Recent tab displays the methods from the database in the order of most recently selected ...

Страница 83: ...t be inserted in the USB port next to the touch screen You will need to pop open the drive head cover in order to access this USB port Backups are stored and retrieved from a folder named Archives in the flash drive NOTE Exporting the instrument database will overwrite any existing archive in the root directory of the USB drive NOTE Importing the instrument database will overwrite the existing ins...

Страница 84: ...nts Allows the user to add any notes specific to the method The following field titles e g Drug Name Dosage can also be edited by the user though the configuration settings on the title screen Drug Name The name of the drug the method is designated to test e g prednisone Dosage The amount of the drug to be tested e g 300 mg Method ID A secondary identifier for the method This does not need to be u...

Страница 85: ...erval at which the tester status speed temperature etc is logged to the test report The range is 0 to 99 00 hh mm If the user does not wish the status to print the Print Interval should be set to 00 00 NOTE The tester status is printed by default at all sample points even if the print interval is set to 00 00 Speed Tolerance The tolerance for the motor speed for a dissolution test The default valu...

Страница 86: ...pling tab Sampling Mode determines the type of sampling procedure Manual For manual sampling When manual sampling is selected the user has the option of defining how long the paddles remain spinning after a test has ended to allow for collection of the last sample This time is entered in the Vessel Offset Time field Automated At Point In At Point mode the syringe begins loading the sample volume c...

Страница 87: ...12 x 32 Rinse Volume The amount of volume pumped before collection is done The range is 0 99 9 mL This volume should be large enough to ensure that old material in the sampling lines is rinsed to ensure the sample collected is representative of what is in the vessels of the tester This parameter applies only in automated sampling mode The default value is 7 mL Collect Volume The volume collected i...

Страница 88: ...source after sampling The range is 0 99 9 mL Generally the media replace volume should be set to be the same as the total of the rinse volume and the collect volume Options tab The Options tab allows for testing options to be set outside of sampling and dissolution tester settings Number of Vessels the number of vessels that will be used during the test The options are 6 or 12 Perform Infinity Tes...

Страница 89: ...OTE Pre run and post run events cannot be sampling events Pre Run Events programmed as a pre run event will occur before the test begins For example an operator programs a pre run event of Drive Speed for 25 rpm Prior to the test starting the motor will spin at 25 rpm When the test begins the motor will go to the speed programmed on the Dissolution tab Post Run Events programmed as post run will o...

Страница 90: ...ct to restrictions on cover page To add a new event touch the Add Event button the following screen is displayed Add Event screen The Add Event screen allows the user to add an event or events to the event table Event Time This defines the start of the first event The range is 0 00 to 999 00 hhh mm Preset buttons are Pre Run and Post Run ...

Страница 91: ...rt a Test 1 Run button To start a test first begin at the main screen and touch the Run button on the toolbar 2 Method tab Touch the Method tab and then the Select Method button Select the desired method from the list The method selected is matched against the current instrument configuration for compatibility NOTE this screen is also used to abort a test that is currently running ...

Страница 92: ...r information screen b Touch Next to continue NOTE The labels for the headers can be changed through the configuration screens The default fields are Report Name Allows the user to enter a final report name By default the report name is a timestamp plus the method name Test Number Allows the user to input the lot number of the item being tested Lot Number Lot number associated with the test run Co...

Страница 93: ...n Test When Temperature Ready Starts the test when the bath temperature is within specification Requires automation Turn Heater Off After Test This option causes the CD14 Tester instrument to turn off the heater at the end of the dissolution test in order to reduce power consumption Auto Print Test Report Determines if the test report will automatically print at the end of the test Side A Side B T...

Страница 94: ...nd side B will be in separate windows NOTE The serial numbers of the items selected will be included in the final report c Touch the OK button to exit 6 Start a Sequence prompt When the bath vessel temperature is within tolerance the user is prompted to start a sequence where he or she is prompted to establish time zero and drop the dosages in each vessel as per the vessel offset time established ...

Страница 95: ...skets i Raise the spindle shafts to their highest point ii Lower the drive head to the testing position iii Cover the vessels iv Allow the media to stabilize b Paddles i Lower the paddles into the media to about 1 cm above the testing height The CD14 Tester drive head should be lowered ii Cover the vessels and allow the media to stabilize c Paddles with ADD Cover i Close the chamber of the ADD cov...

Страница 96: ...osition 1 vi Repeat the previous steps for the remaining positions in turn based on the desired stagger time b Paddles i Drop the dosage into vessel 1 by lifting up the side of the vessel cover and inserting the dosage through the opening into the vessel while grasping the spindle clamp so the paddle does not spin ii Push the paddle down into the testing position and start the test iii Replace the...

Страница 97: ...ampler User Guide 75 108 800 Rev B 31 May 2021 96 of 130 EAR99 technology subject to restrictions on cover page v Replace the vessel cover over position 1 vi Repeat the previous steps for each of the remaining positions in turn based on the desired stagger time ...

Страница 98: ...asive materials which may cause damage to these parts It is best to dry these items right away so they don t stain Weekly Check bath water level and fill if needed Inspect bath water for algae or other contaminants Drain and replace if necessary If bath water develops algae in less than 3 months make sure to clean the bath very thoroughly Every 6 Months Replace bath water and clean the bath regard...

Страница 99: ...e shafts in the spindles can be adjusted by the application of silicone grease If the shafts become too loose after the application they can be tightened by wiping the shaft with ethanol to remove some of the grease Belt Replacement Teledyne Hanson recommends replacing all belts at one time 1 Grasp the drive head cover on both sides and lift straight up to remove the cover 2 Use a 5 32 hex key to ...

Страница 100: ...h is cleaned the longer it will stay clean Do not use coarse or abrasive materials They may scratch the bath Alcohol based products can cause the bath to crack Warning The use of chemicals may damage the waterbath and will not be covered by the warranty Adjustments and Calibration Spindle Shaft Height Adjustment 1 Install the paddle into the spindle shaft 2 Lower the drive head and place a height ...

Страница 101: ...short period of time 3 days or more the power should be turned off If the tester will not be used for an extended period of time 30 days or more the instrument should be cleaned the bath drained and the tester unplugged from the power source The instrument is heavy and great care should be taken when moving it If the instrument is moved to a new location revalidation should be considered Five peop...

Страница 102: ... plunger Syringes should be replaced when they have reached 100 000 cycles regardless of whether or not they are leaking For instructions on syringe replacement refer to the syringe replacement section below Every 6 Months Inspect sample lines and fittings Ensure all fittings are tight Sample lines should be free of debris kinks or breaks For information on how to remove debris from the lines or r...

Страница 103: ...their specified rinse volumes a priming step is performed on the wash lines any time the needles return to that position The priming step dispenses out the probes of the first CD14 Tester A NOTE It is recommended to have at least 100 mL of volume available in tester A prior to beginning a wash cycle The waste lines are rinsed in the same manner as the testers then drained After the waste lines are...

Страница 104: ...pply the DI grade water to source C From the cleanest source pump out to the dissolution testers and collectors This will push any debris away from the valves and help prevent any damage or clogs from occurring Syringe Replacement Replace syringe plungers when the maintenance log indicates 100 000 cycles or as needed After replacing syringes volume calibration should be performed DI or better qual...

Страница 105: ...adjust the plunger and try again Once the screw is flush with the syringe plunger it may be tightened with a screwdriver Volume Calibration Use DI grade water at room temperature 1 Weigh empty sample collection vials or test tubes and record the results tare weight Caps are required in order to ensure accuracy 2 Program the autosampler to collect the required sample volume 3 Weigh full sample coll...

Страница 106: ... side tolerance 0 00496 Note high side tolerance AutoMag probes AutoMag 0 0503 0 01979 Common items Tubing length inches Tubing length cm 1 8 in stainless steel probes 15 38 1 1 16 in stainless steel sample return probes 17 05 43 307 CD AutoPlus tubing on source A B and C 36 91 44 CD AutoPlus tubing on source D 36 91 44 AutoFill to needle Total mL CD14 Tester or extension tubing harness 3 36 91 44...

Страница 107: ...r UV analysis c Filters may be used at operator discretion Procedure This procedure uses only line A1 There is no need to perform this procedure on other lines See the Carryover section in this maintenance section for how to perform a carryover test to verify the rinse volume on all the lines 1 Prime line A1 with no less than 20 mL using DI water 2 Use the CD AutoPlus controls to obtain two sample...

Страница 108: ...us controls 9 Repeat steps 6 through 8 until a total of 10 samples of the absorbing solution are obtained 10 Run the samples on a UV Vis spectrophotometer starting with the two blanks and working from the lowest rinse volume to highest 11 Clean probes using DI water 12 Use the following equation in order to determine the rinse volume 𝐴 𝐴 𝐴 99 100 𝐴 Ar the minimum absorbance required A100 the avera...

Страница 109: ...alue obtained in step 4 by 1 00 100 A100 A0 99 1 00 6 Add the values in step 5 and step 1 for the final value Carryover The carryover evaluation tests the rinse volume to ensure it is true for all the lines in the system This test is performed on all lines used but only on source A Materials required 1 One UV Vis spectrophotometer 2 One absorbing solution with a UV absorbance of approximately 1 00...

Страница 110: ... CD AutoPlus controls obtain a sample of the blank solution 4 Place the sample probes in the absorbing solution 5 Rinse with the previously determined rinse volume 6 Using the CD AutoPlus controls obtain a sample of the absorbing solution 7 Place the sample probes in the DI water 8 Rinse with the determined rinse volume 9 Using the CD AutoPlus controls obtain a sample of the blank solution 10 Repe...

Страница 111: ...lank sample 1 Line 2 blank sample 2 continue through Line 8 blank sample 3 Line 1 absorbing sample 1 continue through Line 8 absorbing sample 3 Sufficient Rinse Volume When the absorbance values of the samples are obtained it must be determined whether or not the rinse volume is sufficient To do this use the two following calculations For absorbing solutions Absorbing solution absorbance values mu...

Страница 112: ...instrument is moved to a new location revalidation should be considered Two people are required to lift the CD AutoPlus and or AutoFill Lifting should be done with one person situated on each side of the instrument Remove the collection rack before moving the instrument Lift the equipment by the base applies to both the CD AutoPlus and the AutoFill Warning Lifting without assistance may cause inju...

Страница 113: ...ire phone support please call 818 882 7266 and select the option for Technical Support Please have the following information available 1 Instrument Type 2 Serial Number 3 Firmware Version 4 What is the system configuration How is the tester connected to other equipment 5 How long did the equipment work before the problem occurred 6 How old is the equipment 7 Were there any recent repairs or mainte...

Страница 114: ...B drive is not formatted The Teledyne Hanson USB drive has already been formatted If using another USB drive format using a PC USB drive is damaged Use another USB drive USB supply is not working Replace USB board System does not make noise Speaker volume set to 0 Use Display screen to raise speaker volume Display board is damaged Replace display board Screen is illuminated but system not responsi...

Страница 115: ...o tight or too loose Replace or adjust belts Tester feet are not touching the bench Ensure all feet of the tester are secure on the bench Other vibration sources Remove these other sources or relocate the tester Paddle basket heights not correct Improper operation Confirm that spindle clamp and spindle are properly engaged Confirm that paddle or basket shaft is properly tightened in the spindle sh...

Страница 116: ...ertain temperature Component failure Contact Teledyne Hanson Technical Support Tester heats up to different temperature than set point Set point has changed due to test starting Confirm set point on main screen Offset for heater probe is incorrect Correct heater probe offset in probe calibration screen Heater probe has failed Replace heater probe External temperature probe offset is incorrect Corr...

Страница 117: ...s not moving at all Magazine not configured Ensure method makes use of magazine Ensure magazine is set up in Device Setup Component failure Contact Teledyne Hanson Technical Support Vessel temperature probes not working Vessel temperature probes not configured Ensure probes are configured in the device setup Vessel temperature probes not connected Ensure that probes are connected to tester main bo...

Страница 118: ...not stuck Consult printer operation manual Prints a little and then light blinks Paper incorrectly installed Check paper to see that it is installed correctly and that the paper indicator button is not stuck Consult printer operation manual Will not print No paper Replace paper roll Paper incorrectly installed Check paper to see that it is installed correctly and that the paper indicator button is...

Страница 119: ... page Network Printer Troubleshooting Problem Possible Causes Recommended Action Tester will not print IP address incorrect Set the IP address of tester to work with printer No PostScript support Switch to a printer with PostScript supported by the printer firmware Printer settings incorrect Ensure printer settings are correct for printer in system configuration ...

Страница 120: ... kg 260 lbs Main unit bath and vessels filled with water 174 kg 383 lbs Size Height 87 6 cm 40 0 in Width 67 3 cm 33 5 in Depth 58 5 cm 24 0 in Bath Capacity With 14 vessels 41 6 liters 11 gallons Power Input 100 230 V 10 50 60 Hz 1 5 A max Output 24 VDC 3 75 A 90 W Heater Specifications Note The heater fits under the tester Weight 4 1 kg 18 lbs Size Height 7 6 cm 3 0 in Width 67 3 cm 26 5 in Dept...

Страница 121: ... rpm Temperature Programmable temperature range 25 0 to 51 0 C Accuracy 0 5 C Control 0 1 C Digital Temperature Probes all probes Range 10 to 60 C Accuracy 0 1 C from 30 55 C Displayed resolution 0 01 C Minimum submersion depth 25 mm Response time 45 seconds normally 30 sec CD AutoPlus Specifications Weight Dry 21 3 kg 47 0 lbs Size Height 46 8 cm 18 4 in Width 38 1 cm 15 0 in Depth 66 0 cm 26 0 i...

Страница 122: ...to restrictions on cover page AutoFill Specifications Weight Dry 14 5 kg 32 0 lbs Size Height 40 1 cm 15 8 in Width 28 0 cm 11 0 in Depth 47 3 cm 18 6 in Power Input 24 VDC 3 75 A 90 W Only use external power supply listed below CD AutoPlus AutoFill External Power Supply Power Input 100 240 V 50 60 Hz 1 5 A max Output 24 VDC 3 75 A 90 W ...

Страница 123: ...1 to 15 0 mL 0 15 Sampling Minimum sample interval 1 min 5 min is normal Maximum sample interval 999 hours 59 min 999 59 Sample time points 50 maximum Maximum sample volume 90 of vial capacity Collection 13 x 100 rack 18 x 8 test tubes 144 total 16 x 100 rack 18 x 8 test tubes 144 total 12 x 32 rack 21 x 8 vials 168 total UPLC rack 12 x 32 3 trays 6 x 8 vials 144 total Septum Pre cut type only War...

Страница 124: ...1 L Glass Amber Serialized Borosilicate glass 75 107 121 Vessel Easi Lock Super Precision Vessel 1 L Glass Clear Borosilicate glass 75 107 022 Vessel Easi Lock Super Precision Vessel 1 L Glass Amber Borosilicate glass 75 107 150 Dual AutoMag 12 Positions Factory Installed PVDF PTFE PEEK ETFE 75 107 151 Dual AutoMag 12 Positions Field Installed PVDF PTFE PEEK ETFE 75 107 160 Probe Kit PEEK 12 Posit...

Страница 125: ...50 076 Maximizer Valve PEEK EPDM PFE 304SS 60 200 550 5 mL Syringe PTFE PEEK Borosilicate Glass AutoFill Wetted Materials Part Number Description Material s 61 207 717 Home Port Stand PVDF 61 207 723 PEEK Needles PEEK 91 030 051 16 mm x 100 mm Test Tubes Borosilicate Glass 91 030 150 12 mm x 32 mm Vials Borosilicate Glass Silicone PTFE 61 107 003 16 mm Evaporation Caps Polyethylene 61 105 029 Syri...

Страница 126: ...ied for glassware consumables or products not manufactured by Teledyne Hanson as evidenced by nameplate on the item or other designation Teledyne Hanson will give reasonable assistance to buyer in obtaining from the respective manufacturer whatever adjustment is available under the manufacturer s own warranty Teledyne Hanson shall be released from any and all obligations under any warranty either ...

Страница 127: ...figuration of digital temperature probes 2005 5 Vessel probe X offset out of range User tried to apply an offset greater than 9 99 or less than 9 99 1 Probe offset is entered correctly 2 Temperature probe failure 2006 5 External temperature probe 2 failure Heater cannot communicate with external temperature probe 1 External probe connection 2 External probe failure 3 Heater board failure 2007 5 Ve...

Страница 128: ...ode 2 Calibration error 1 Move it again Make sure motor is moving 2 Check lead screw and magazine coupling 3 Spindle control board failure 2017 5 Spindle X spindle board com recovery The tester had communication problem with the spindle board 1 Check the connection 2 Spindle board failure 3 Main board failure 2018 5 Spindle X commute error ecode 1 Spindle motor commutation error 1 Run it again mak...

Страница 129: ...ailure 3 Heater board failure 2502 5 Heater input power mains error ecode 0x80 heater failure 1 Emergency thermo switch has tripped breaking the connection between the heater and power source 2 Heater coil connection 3 Heater coil failure 4 Heater board failure 2503 5 Heater thermistor sensor failure ecode 4 Heater cannot communicate with safety probe 1 Safety probe connection 2 Safety probe failu...

Страница 130: ...s not full 0067 1 Cannot write to file Error when accessing the USB thumb drive 1 Check the USB thumb drive is not write protected 2 Check the USB thumb drive is not full 0068 1 Unhandled error Error when accessing the USB thumb drive Try again 0070 1 Timeout Fingerprint sensor error Try again 0071 1 Invalid serial baud rate Internal error Contact Teledyne Hanson 0072 1 The specified ID is not in ...

Страница 131: ...y 2021 130 of 130 EAR99 technology subject to restrictions on cover page Teledyne Hanson 9810 Variel Avenue Chatsworth CA 91311 USA Phone 1 818 882 7266 www teledynehanson com Copyright 2021 Teledyne Hanson a division of Teledyne Instruments Inc Document 75 108 800 Rev B ...

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