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B. Regulatory and Safety

46-208-208 Rev. B—XTRX500 User Guide

B-1

Regulatory Compliance

Teledyne  Hanson  hereby  certifies  that  this  product,  including
hardware  and  firmware,  was  designed,  evaluated,  validated,
inspected,  and  tested  to  approved  specified  quality
requirements of THR in conformance with current USP, EP, JP,
and other international standards (India & Korea).

Canadian Emissions Notice

This digital apparatus does not exceed the Class A limits for
radio noise emissions from digital apparatus set forth in the
Radio Interference Regulations of the Canadian Department of
Communications.

Le présent appareil numérique n’émet pas de bruits
radioélectriques dépassant les limites applicables aux appareils
numériques de la classe A prescrites dans les réglementés sur
le brouillage radioélectrique édictés par le Ministère des
Communications du Canada.

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Содержание XTRX500

Страница 1: ...XTRX500 SAMPLE PREPARATION EXTRACTOR USER GUIDE 46 208 208 Rev B 8 July 2020 ...

Страница 2: ...ledyne Hanson helps ensure the world s pharmaceuticals are pure safe and effective by manufacturing equipment that sets the global standard for quality innovation and long term value Teledyne Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry s top customer service team For more information visit teledynehanson com Headquarters Teledyne Hanso...

Страница 3: ...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 hansontechsupport teledyne com Phone 1 818 882 7266 Teledyne Hanson 9810 Variel Avenue Chatsworth CA 91311 USA ...

Страница 4: ...evision History Revision Date Revised Description of Change A 28 Feb 2019 Original issue B 8 July 2020 Changed name to XTRX500 Sample Preparation Extractor To confirm that you have received the latest version of this user guide contact Teledyne Hanson Technical Support ...

Страница 5: ...B XTRX500 User Guide TOC 1 Table of Contents A Introduction A 1 B Regulatory and Safety B 1 C Installation C 1 D Operation D 1 E Sample Preparation E 1 F Maintenance F 1 G Troubleshooting G 1 H Specifications H 1 I General Warranty I 1 ...

Страница 6: ...omplete XTRX500 installation and service Cassette The removable front part of the XTRX500 into which the extraction pouches are loaded Consumable pack A consumable pack consists of either 100 x 100 mL extraction pouches or 100 x 500 mL extraction pouches HPLC High Performance Liquid Chromatography Scanner An equivalent term for barcode reader SOP Standard Operating Procedure XTRX500 Sample Prepara...

Страница 7: ...A Introduction 46 208 208 Rev B XTRX500 User Guide A 2 Sample Preparation Extractor Overview Sample preparation extractor XTRX500 system description ...

Страница 8: ...A Introduction 46 208 208 Rev B XTRX500 User Guide A 3 100 mL extractor pouch 500 mL extractor pouch Fluid lifter tool back Fluid lifter tool front ...

Страница 9: ...tilles Wax suppository Large tablets up to 40 mm width and small tablets 3 mm width NOTE The system is not to be used with effervescent tablets or mixtures that produce a gas when mixed together The system includes instrument electromechanical device with firmware software plus consumable provides automated rapid extraction of dosage forms The operator is responsible for fluid addition filtration ...

Страница 10: ... barcoded to achieve a high level of sample traceability and method tracking making it easy for the user to run multiple method steps In the event of a user accident spillage or a leak from the extraction pouch the XTRX500 should be switched off immediately and the leak contained in line with the Standard Operating Procedure following Good Laboratory Practice Once the instrument is switched off an...

Страница 11: ...08 208 Rev B XTRX500 User Guide A 6 Always unplug the unit from the mains power before any maintenance cleaning or servicing that requires operations with the cassette removed or if a leak occurs Drain tube Hose attached ...

Страница 12: ...fety instructions 3 Unpack inspect and install the instrument according to instructions in the installation section 4 Conduct an initial test of the system using the procedures outlined in the operation section 5 Review the maintenance and troubleshooting sections to become familiar with keeping the instrument in good working condition 6 Immediately contact Teledyne Hanson Technical Support with a...

Страница 13: ...international standards India Korea Canadian Emissions Notice This digital apparatus does not exceed the Class A limits for radio noise emissions from digital apparatus set forth in the Radio Interference Regulations of the Canadian Department of Communications Le présent appareil numérique n émet pas de bruits radioélectriques dépassant les limites applicables aux appareils numériques de la class...

Страница 14: ...8 208 Rev B XTRX500 User Guide B 2 The following safety symbols are used throughout this manual Symbol Definition General warning of potential damage or danger from a variety of sources Caution risk of electrical shock high voltage ...

Страница 15: ...RX500 is always operated within a fume cupboard regardless of the solvent being used The instrument is not to be used with chemicals that self ignite If the XTRX500 is used with materials that are a biohazard then the material must be handled appropriately according to existing SOP s Declaration of Conformity See Declaration of Conformity sheet enclosed with the instrument General considerations C...

Страница 16: ... or internal grounding connections Tampering with or disconnecting these connections could endanger life and or damage the sample preparation extractor The instrument is properly grounded in accordance with these regulations when shipped No changes to the electrical connections or the instrument s chassis are required to ensure safe operation Do not turn the instrument on if any kind of electrical...

Страница 17: ... at the mains before unplugging the power cord The XTRX500 should be unplugged from the mains prior to cleaning or maintenance of the instrument Regular electrical testing should be carried out on the instrument This should be performed to the local standard equivalent to Portable Appliance Testing PAT Other hazards It is imperative to ensure the warnings on these labels are adhered to and all ope...

Страница 18: ...ystem is not to be used with effervescent tablets or mixtures that produce a gas when mixed together The XTRX500 should not be used with solvents that self ignite There are no operator serviceable parts on the electronic boards If an electronic board fails contact a Teledyne Hanson representative The sample preparation extractor is to only be used with Teledyne Hanson approved consumables Extracti...

Страница 19: ...ty 46 208 208 Rev B XTRX500 User Guide B 7 Labelling The following warning labels are used on the XTRX500 Position Label Symbols On the main body of the XTRX500 below the barcode reader Caution moving parts Keep hands clear ...

Страница 20: ...t any excess solvent or solution can be safely disposed of in line with the user s in house Standard Operating Procedures Lighting The XTRX500 does not contain any lighting units to illuminate working areas Sufficient lighting must be provided by the user Ventilation The XTRX500 does not contain ventilation provision Sufficient ventilation must be provided by the user in line with standard laborat...

Страница 21: ...r must ensure that the drain tube is not blocked kinked or obstructed in any way and any fluid drains away from the XTRX500 unit quickly and to a safe waste container For details on how to run Immediate Mode along with creating and running new methods please consult section E Sample Preparation Maintenance functions The XTRX500 should only be used with Hanson supplied extraction pouches The sample...

Страница 22: ...he XTRX500 be aware of the maintenance schedule and ensure any daily tasks are completed see section F for maintenance schedule Standard operation mode NOTE There are two types of extraction pouch Each is a different volume see the pictures below for the differences between them The 100 mL extraction pouch has a minimum working volume of 25 mL and a maximum of 100 mL the 500 mL extraction pouch ha...

Страница 23: ...ion pouch are clipped firmly together as shown in the picture below In addition when the extraction pouch is loaded into the cassette any solid sample is contained in the space above the jaws and not allowed between the jaws Failure to ensure this will result in the inability to mount the cassette on the XTRX500 Jaws of extraction pouch Ensure they are firmly clipped together ...

Страница 24: ...RX500 User Guide D 3 Cassette removed from the XTRX500 showing extraction pouch mounting bracket in the up and down position Extraction pouch mounting bracket in the up position Extraction pouch mounting bracket in the down position ...

Страница 25: ...D 4 Cassette removed from the XTRX500 showing detail of the extraction pouch mounting plate and the open bracket for loading samples into the extraction pouch Extraction pouch mounting plate Open bracket for loading samples into the extraction pouch ...

Страница 26: ...0 User Guide D 5 Step 1 Load the extraction pouch into the XTRX500 as shown in the pictures below First remove the cassette from the XTRX500 as shown The action required to remove this is to pull the cassette up and away from the XTRX500 ...

Страница 27: ... User Guide D 6 With the cassette removed from the XTRX500 and ensure both the extraction pouch mounting bracket and sample loading bracket are open Sample loading bracket Extraction pouch mounting plate Extraction pouch mounting bracket ...

Страница 28: ... extraction pouch to the extraction pouch mounting plate with the lower lugs mounted first and push firmly into place The extraction pouch should load with a distinctive click Lower lugs of extraction pouch Extraction pouch clicked in place mounted first on mounting plate ...

Страница 29: ...ion pouch is slipped over the tab at the top of the sample loading bracket Smooth the extraction pouch into place in the cassette then raise the extraction pouch mounting bracket Top tab of the extraction pouch Smooth the extraction pouch into slipped over the sample loading place in the cassette bracket ...

Страница 30: ...D Operation 46 208 208 Rev B XTRX500 User Guide D 9 Step 3 continued Smooth the extraction pouch into Raise the extraction pouch place in the cassette mounting bracket ...

Страница 31: ...oaded correctly onto the XTRX500 as shown Incorrect orientation may lead to malfunction and damage to the XTRX500 Note that this is the same for both types of extraction pouch Step 4 The required amount of solvent for the dissolution process is added to the extraction pouch followed by the sample to be dissolved Add solvent to the extraction Add samples to be dissolved pouch ...

Страница 32: ...X500 User Guide D 11 Step 5 The top of the extraction pouch is closed It is very important that the sample stays in the top of that extraction pouch and does not go into the jaws Correct location of sample Incorrect location of sample ...

Страница 33: ...d is not necessary if the cassette is aligned correctly with the XTRX500 NOTE If the barcode reader does not scan the extraction pouch barcode correctly this can be due to the sample causing the barcode to be misaligned In this situation the sample should be moved slightly in the top of the extraction pouch until the barcode is scanned correctly The XTRX500 can now be used for the dissolution proc...

Страница 34: ...required to remove this is to pull the cassette up and away from the XTRX500 The solvent lifter tool a k a pouch compression tool is fitted to the inside of the cassette with the soft face against the extraction pouch Removal of the cassette pull Fitting the solvent lifter tool with the up and away from the XTRX500 soft face against the extraction pouch ...

Страница 35: ...o the Screw in the solvent lifter tool to locating lugs on the inside of raise the level of the solvent the cassette NOTE Samples may be taken from the pouch using the solvent lifter tool accessory and syringe or the long sampling cannula and syringe provided NOTE Once the test is complete and the pouch removed from the cassette the pouch can be hooked onto the pouch stand with hooks provided Note...

Страница 36: ...0 User Guide D 15 Step 9 Once the solution is at the correct level at the top of the extraction pouch an aliquot is removed using a syringe Solution at correct level at top Remove an aliquot of solution with of extraction pouch a syringe ...

Страница 37: ...10 The extraction pouch can be removed from the cassette This is done by raising the extraction pouch release lever unhooking the extraction pouch from the sample loading bracket and lowering the extraction pouch mounting bracket Extraction pouch release lever ...

Страница 38: ...te Unhook the extraction pouch from Remove the extraction pouch from the sample loading mounting plate the cassette with extraction pouch mounted bracket lowered NOTE The solution can be kept for further analysis or disposed of in a safe manner as described by the user s SOP The extraction pouch can be disposed of via incineration ...

Страница 39: ...E Sample Preparation 46 208 208 Rev B XTRX500 User Guide E 1 Running Immediate Mode and creating and running new methods Rotary encoder and select button Back button ...

Страница 40: ...reen select Run by pushing down on the rotary encoder button Immediate Mode screen Pouch Two extraction pouch sizes available 100 mL and 500 mL The barcode reader automatically detects which size extraction pouch is loaded Step 2 Crusher The XTRX500 can be used with the crusher ON or OFF These options are selected with the rotary encoder switch dial ...

Страница 41: ...d leak when fluid is added Step 4 Solvent The amount of solvent used is selected from between 0 mL and 500 mL NOTE 1 If too little solvent is used for the extraction pouch size then an error screen is shown when Run is selected The 100 mL extraction pouch requires a minimum of 25 mL of solvent to ensure good mixing the minimum amount required for the 500 mL Extraction Pouch is 100 mL NOTE 2 If too...

Страница 42: ...traction pouch is 100 mL Step 5 Time The total mixer crusher time is selected from 5 s to 1 h 0 m 0 s The time is changed and set by using the rotary encoder dial switch Step 6 Run Selecting this will run the XTRX500 with the conditions set The Running screen shows the crusher ON OFF mixer ON OFF Run time and time remaining ...

Страница 43: ...nd resumed as many times as required up to the maximum run time allowed From the Run Stopped screen the run can be either resumed or cancelled NOTE It is important to ensure all solid compound is extracted and not within the crushing zone before stopping a run It will NOT be possible to replace the cassette once removed if the crusher plates in the extraction pouch are not closed together which ca...

Страница 44: ...s selected the XTRX500 returns to the Immediate Mode screen The Immediate Mode can be re run up to a maximum of 30 times this can be useful for dissolution method development If the run is stopped and cancelled the Pouch Status screen is displayed with the last event showing Stopped by user If Finished is selected the XTRX500 returns to the home Start up screen Step 7 If it is decided not to run t...

Страница 45: ...ample Preparation 46 208 208 Rev B XTRX500 User Guide E 7 Methods Menu Creating and running methods Step 1 From XTRX500 home start up screen select Methods Step 2 From Methods Menu screen select Add method ...

Страница 46: ...ETHOD X X being the next number in numerical order compared to existing methods Select NEW METHOD X Step 4 From Edit Name screen use the alphanumeric display to select a method name Once the method name is selected the XTRX500 automatically returns to the Edit Method screen Note the extraction pouch size is automatically selected from the barcode ...

Страница 47: ...pouch size then an error screen is shown when Run is selected The 100 mL extraction pouch requires a minimum of 25 mL of solvent to ensure good mixing the minimum amount required for the 500mL extraction pouch is 100 mL NOTE 2 If too much solvent is used for the 100 mL extraction pouch then another error screen is shown when Run is selected The maximum amount of solvent that can be used in this ex...

Страница 48: ... be used in a single method Step 7 Crusher The crusher can be ON or OFF These options are selected with the rotary encoder switch dial Step 8 Mixer The mixer can be ON or OFF These options are selected with the rotary encoder switch dial NOTE The mixer should only be ON if there is fluid in the extraction pouch or the extraction pouch may become damaged and leak when fluid is added Step 9 Time The...

Страница 49: ... or adding a pause event is available An Action Event involves running the crusher and or mixer for a set period of time as already described in Step 6 10 A Pause event allows the addition of another or further solvent as required The XTRX500 programming will not allow the maximum amount of solvent added to exceed the capacity of the extraction pouch used In both the Action Event and Pause Event m...

Страница 50: ...can be saved in the Edit Method menu Step 13 Once saved in the Edit Method menu the XTRX500 automatically goes to the Methods Menu Any of the stored methods can be accessed from the Methods Menu Selecting a method gives the Method Action menu This menu displays the method name and allows the user to View Run Edit Copy Delete or return to the Methods Menu screen by selecting Done Note The Done opti...

Страница 51: ...view the selected method The XTRX500 displays the method name extraction pouch size Total Solvent and Total time along with details of the events used Run Allows the user to run the method selected The Running screen shows the crusher and mixer ON OFF the run time and the time remaining ...

Страница 52: ...e used The run can be stopped at any stage by selecting Stop The Run Stopped screen shows the Run Time Time Remaining and the option to Resume or Cancel as described in Step 6 above In the Method Action menu selecting Edit allows the user to edit the method selected All the details of the method can be edited including the method name Initial solvent amount along with the number and details of the...

Страница 53: ...ready stored on the XTRX500 In the Method Action menu selecting Delete allows the user to delete the selected method Once the method is deleted the XTRX500 returns to the Methods Menu If Cancel is selected from the Delete Method menu the XTRX500 returns to the Method Action screen Done When this is selected in the Method Action menu the XTRX500 returns to the Methods Menu screen The Done function ...

Страница 54: ... This allows the user to update the firmware from a file supplied by Hanson Instructions for updating the firmware will be supplied by Hanson at the time of the update If the memory stick is left plugged into the XTRX500 for 5 minutes with no action taken then the instrument reverts back to the home screen ...

Страница 55: ...User Guide E 17 Locking Methods Stored methods can be locked so that they are not copied or inadvertently deleted or edited From the main home screen select Options From the Options Menu select Methods In the Method Options menu select Lock Methods ...

Страница 56: ...ods is selected the Set Password menu is displayed The main switch dial is then used to input a six digit code for the password When OK is selected the Confirm Password screen is displayed When the password is confirmed select OK This gives the Password set successfully screen ...

Страница 57: ...is not confirmed correctly the Failed to set password screen is displayed If Cancel is selected in the Set Password menu then the Password not changed screen is displayed To remove the password in the Set Password menu enter 000000 as the password to disable the password function ...

Страница 58: ...e Preparation 46 208 208 Rev B XTRX500 User Guide E 20 The Method Edit Password Disabled screen is then displayed Once the password is set this needs to be re entered when methods are copied edited or deleted ...

Страница 59: ...E Sample Preparation 46 208 208 Rev B XTRX500 User Guide E 21 About Selecting About in the options menu displays the About XTRX500 screen ...

Страница 60: ... 46 208 208 Rev B XTRX500 User Guide E 22 History Selecting History in the options menu displays the History screen Unlock Selecting Unlock in the options menu enables manual unlocking of the cassette in the event of a jam ...

Страница 61: ...s The sample preparation extractor has been designed to be compatible with standard HPLC polar solvent ranges and weak acids and base solutions buffers For specific advice contact a Teledyne Hanson representative Recommended routine maintenance At each test clean up any spills On a weekly basis clean the unit by wiping with a damp cloth ...

Страница 62: ...he 500 mL extraction pouch is 100 mL Increase the amount of solvent in the extraction pouch to at least the minimum acceptable level Error 001c Too much solvent for pouch size Too much solvent added to the 100 mL extraction pouch The maximum amount of solvent that can be used is 100 mL Reduce the amount of solvent in the extraction pouch to at least the maximum acceptable level Error 0025 This pou...

Страница 63: ...an the maximum number of events that can be run with a single extraction pouch Reduce the maximum number of events in the method Cannot load the cassette onto the XTRX500 The jaws of the extraction pouch were not clipped together and the sample has slipped between them Relocate the sample ensure the jaws are clipped together and the sample does not slip between them Unable to unlock the cassette f...

Страница 64: ... socket rear panel Environment Operating Temperature Range 15 C to 30 C 59 F to 86 F Maximum Relative Humidity 85 non condensing Operational Parameters Extraction Mode Dry High Frequency Pulverize then Force Jet Mix or Force Jet Mix and High Frequency Pulverize simultaneous Electrical Specifications Power supply input 100 240 VAC 2 5 A 50 60 Hz grounded Power supply output 24 VDC 6 25 A 150 W max ...

Страница 65: ...ning 1 pouch stand kit 1 manual sampling cannula 24 single use syringes 20 mL and 1 cassette Purchase of one or more spare cassettes is recommended for higher throughput ACCESSORIES 46 201 204 XTRX500 Cassette Spare 46 201 205 XTRX500 Pouch Compression Tool 46 201 210 XTRX500 Pouch Stand Kit incl 20 S Hooks 46 201 212 S Hooks for Pouch Stand Pack of 20 74 105 360 2 Liter Manual Sampling Cannula CO...

Страница 66: ...y 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 expressed or implied if the product covered is repaired or m...

Страница 67: ...Teledyne Hanson 9810 Variel Avenue Chatsworth CA 91311 USA Phone 1 818 882 7266 www teledynehanson com Copyright 2020 Teledyne Hanson a division of Teledyne Instruments Inc Document 46 208 208 Rev B ...

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