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Revision History

Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016

RH-1

Document Revision History

Revision

Date Revised

Description of Change

A

14 November 2016

Original issue

To confirm that you have received the latest version of this user
guide, contact Hanson Research Technical Support.

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Summary of Contents for 40-101-001

Page 1: ...PHASE ONE DISINTEGRATION TESTER USER GUIDE Hanson Research Corporation 40 108 001 Rev A 14 November 2016...

Page 2: ...effective by manufacturing equipment that sets the global standard for quality innovation and long term value Hanson instruments are used by scientists in over 75 countries worldwide and are supporte...

Page 3: ...rom 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 We re happy to help Website www hansonresear...

Page 4: ...e 40 108 001 Rev A 14 November 2016 RH 1 Document Revision History Revision Date Revised Description of Change A 14 November 2016 Original issue To confirm that you have received the latest version of...

Page 5: ...ide 40 108 001 Rev A 14 November 2016 TOC 1 Table of Contents A Introduction A 1 B Regulatory and Safety B 1 C Installation C 1 D Operation D 1 E Disintegration Testing E 1 F Maintenance F 1 G Trouble...

Page 6: ...set of two reciprocating arms driven by a single electric motor and other components as shown in the illustration below The tester supports methods requiring two baskets running simultaneously the bas...

Page 7: ...it featuring a built in over temperature shut off circuit The H C is self contained with an easy to read LCD display and a touchpad for setting the temperature Heater Power Requirements Heater circula...

Page 8: ...p of the beakers and can be used to plug the holes in the waterbath lid to reduce evaporation Tester Operation Overview Once the tester has been unpacked installed and qualified routine operation cons...

Page 9: ...son Research recommends the following steps for making best use of this user guide 1 Review the Introduction section for an overview of the instrument 2 Carefully review and follow all safety instruct...

Page 10: ...pas de bruits radio lectriques d passant les limites applicables aux appareils num riques de la classe A prescrites dans les r glements sur le brouillage radio lectrique dict s par le Minist re des C...

Page 11: ...ive 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 Mains supply voltage fluctuations not to exceed 10 of the n...

Page 12: ...e 40 108 001 Rev A 14 November 2016 B 3 The following safety symbols are used throughout this manual Symbol Definition General warning of potential damage or danger from a variety of sources Electrica...

Page 13: ...es instrument maintenance must be performed only by authorized service personnel Injury can occur if untrained personnel are servicing the tester with the rear cover removed An electrical grounding sy...

Page 14: ...of about 15 mm 0 6 inches between the top of the arm and edge of the slot and although the arms cannot move further because the drive mechanism prevents it the operator should nevertheless keep clear...

Page 15: ...ember 2016 B 6 To authorized service personnel When the back cover is removed and power is supplied to the drive motor multiple components will rotate and slide when the tester is commanded to run The...

Page 16: ...tions in temperature Space Requirements Please refer to Specifications section for space requirements based on the physical dimensions of the tester The bench should be level and flat It must be capab...

Page 17: ...erial or other debris 8 Place tester in final location on bench Assemble the Tester 1 Place heater into bath compartment do not secure 2 Install bath lid on top of bath while centering the heater in t...

Page 18: ...located on the back side of the unit The switch is oriented for horizontal activation toggle to the left ON toggle to the right OFF as viewed from the front of the unit From the front of the tester r...

Page 19: ...ZE screen will appear instructing the operator to push the control knob with a caution that the arms will begin moving When the control knob is pressed the arms will begin seeking the HOME position al...

Page 20: ...UN As each option is highlighted on the screen a description of that function is shown at the bottom of the display Pushing the control knob activates the highlighted option As each new screen is disp...

Page 21: ...top and bottom static positions of the reciprocating stroke before a test for example to verify conformance to USP requirements select the UPPER position and LOWER position icons shown here To check t...

Page 22: ...will display system information including the firmware version total number of cycles on the tester and the PCB printed circuit board version Selecting ERROR LOG as shown below will display the last t...

Page 23: ...pply The power switch is located partway down the back side of the heater towards the right edge as viewed from the front The toggle switch is oriented for vertical activation toggle to the top ON tog...

Page 24: ...ernately on the display When the time period has elapsed the circulator will make a beeping sound three times then go silent for 15 20 seconds and then repeat the beeping sound The circulator will con...

Page 25: ...fluid required to fill a particular beaker to a specific level in order to accommodate this requirement may vary Use the TOOLS MENU and the procedure below to help establish the fluid level for a tes...

Page 26: ...basket assembly 4 Drop dosage forms into the tubes 5 If disks are required for the test place the disks into the tubes on top of the dosage forms ensuring the small side of the trapezoid is down as s...

Page 27: ...imer 7 Press the Run button to start the heater circulator Verify Media Temperature Allow water in bath to come up to temperature approximately 15 minutes when starting from room temperature Placing b...

Page 28: ...e operator In free run mode the timer counts UP from zero Fixed Time Test To set up a fixed time test at the main menu highlight TIMED TEST and push the control knob The screen will default to the RUN...

Page 29: ...tate the knob until the desired number of minutes is displayed Press the knob to set the minutes The screen will now highlight the number of seconds as shown below Rotate the knob until the desired nu...

Page 30: ...the total number of cycles expected In this mode the PAUSE function will be highlighted Press the control knob at any time to pause the test For further details on this function refer to Pausing a Tes...

Page 31: ...position and any other test preparations are complete Use the TOOLS MENU as needed to help verify the setup With all preparations completed and FREE RUN highlighted press the control knob to start th...

Page 32: ...y The timer will stop counting up or down The orange logo lens will begin blinking The screen will display three choices RESUME LIFT or ABORT Note that the RESUME option will be highlighted by default...

Page 33: ...ESUME or ABORT Note that the RESUME option will be highlighted by default as shown below Selecting ABORT will end the test On activating the ABORT function the process screen shown below will appear t...

Page 34: ...2 Disconnect baskets from arms by tilting and removing from basket shaft holder as shown 3 Use the red plastic drip cups supplied with the tester or other devices to collect drippage while guiding the...

Page 35: ...sket assembly components fluids used to wash or rinse the dark gray plastic parts should not exceed 50 C Beakers If beakers are to remain out of the bath for an extended period of time the red drip cu...

Page 36: ...kers and glass tubes Rinse with warm water and if necessary an appropriate detergent Basket assembly Rinse with warm DI water Waterbath The following procedure is recommended for cleaning the waterbat...

Page 37: ...for a few seconds on the first screen to appear when the instrument is turned on It can also be viewed from the INFO screen accessible as follows From the main menu select TOOLS MENU Select INFO The...

Page 38: ...during the upgrade Phase One Board Replacement Kit p n 40 107 011 This kit consists of a replacement main board pre programmed with the latest version of the firmware This method requires removal of...

Page 39: ...ors are sorted by the order of occurrence such that the latest error is always item 01 on the list Each entry includes the error name error code and the cycle count of the tester when the error occurr...

Page 40: ...sket arms will not move or stopped during operation Defective controller motor failure or mechanical drive failure Contact Hanson Tech Support Sensor error Check error log cycle power to unit If error...

Page 41: ...ure PVC Wire mesh screen Type 316 SS Glass beakers and tubes Borosilicate Disks Acrylic Spare Parts Parts listed below may be ordered separately 6 tube Basket Assembly 40 107 006 designed to meet USP...

Page 42: ...nufactured by Hanson as evidenced by nameplate on the item or other designation Hanson will give reasonable assistance to buyer in obtaining from the respective manufacturer whatever adjustment is ava...

Page 43: ...arch Corporation 9810 Variel Avenue Chatsworth CA 91311 USA Toll Free 800 821 8165 Phone 818 882 7266 Fax 818 882 9470 www hansonresearch com Copyright 2016 Hanson Research Corporation Document 40 108...

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