xtrx500 sample preparation extractor user guide · • wax suppository • large tablets (up to 40...

XTRX500 SAMPLE PREPARATION EXTRACTOR

USER GUIDE

46-208-208-Rev. B—8 July 2020

46-208-208 Rev. B—XTRX500 User Guide

About Teledyne Hanson Teledyne Hanson, a division of Teledyne Instruments, Inc., is a global technology company specializing in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Teledyne Hanson helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Teledyne Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, visit teledynehanson.com.

Headquarters Teledyne Hanson 9810 Variel Avenue Chatsworth, CA 91311, USA Main: +1 818.882.7266 www.teledynehanson.com

Sales and Support

46-208-208 Rev. B—XTRX500 User Guide SUPPORT

Congratulations on your purchase of the Teledyne Hanson XTRX500 Sample Preparation Extractor. 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] Phone: +1 818.882.7266

Teledyne Hanson 9810 Variel Avenue Chatsworth, CA 91311, USA

Revision History

46-208-208 Rev. B—XTRX500 User Guide RH-1

Document Revision 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.

Table of Contents

46-208-208 Rev. 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

A. Introduction

46-208-208 Rev. B—XTRX500 User Guide A-1

Terms and Definitions

BCR: Barcode reader.

Teledyne Hanson Authorized Engineer: A Teledyne Hanson trained and approved engineer that would be an employee of Teledyne Hanson. XTRX500 installation, service and user training are undertaken by Teledyne Hanson Authorized Engineers, where the engineer is qualified to complete 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 Preparation Extractor

System: This comprises the Teledyne Hanson XTRX500 together with accessories to support the processing of samples. Some of the accessories are optional.

A. Introduction


Sample Preparation Extractor Overview

Sample preparation extractor (XTRX500) system description.

A. Introduction


100 mL extractor pouch 500 mL extractor pouch

Fluid lifter tool, back

Fluid lifter tool, front

A. Introduction


An apparatus and consumable for rapid extraction of solid and semi-solid dosage forms.

NOTE: The XTRX500 is designed to be a tool that will allow the analyst to extract and dissolve solid and semi-solid dosage forms. The actual extraction success is highly dependent on the analyst’s ability to develop a method within the constraints of the XTRX500 tool.

The dosage forms include the following, but it should be noted that they are limited to the constraints of the XTRX500 extraction pouch dimensions and design:

• Tablets (immediate and controlled release)

• Lozenge

• Capsules (both gelatin and alternatives)

• Powders

• Beads & granules

• Gels and pastes

• Pastilles

• 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 and dilution steps related to their method, the system gives the user easy access with the ability to add the sample and add and remove fluid at appropriate stages of the method.

The extraction pouch contains all the extraction fluid and no solution should come into contact with the hardware or reusable components, eliminating cleaning between samples.

The XTRX500 is a standalone system appropriate for laboratories and manufacturing units allowing easy and controlled extraction of the product(s).

A. Introduction


The XTRX500 is a standalone instrument that should be operated in a fume cupboard when used with flammable organic solvents. The XTRX500 requires electrical mains power only.

XTRX500 Extraction Pouches The extraction pouch proprietary technology enables rapid extraction and dissolution with a high frequency pulverizing zone and a force jet mixing zone.

The specifically designed extraction pouches remove the need for glassware and are disposed after a single use. They are constructed of a highly durable membrane polymer and have undergone significant testing. They are designed to provide reliable and repeatable sample preparation extractions. The extraction pouches are not designed for long-term storage of solvents and extracted solutions and the user should ensure that solvents are not left in the pouches for extended periods.

The extraction pouches are available in two sizes: 100 mL (working range 25 mL to 100mL) and 500 mL (working range 100 mL to 500 mL).

The extraction pouches are 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 and the leak contained the XTRX500 can be easily cleaned and dried and has splash/leak protection. It is designed to contain sample and fluids to these areas, up to the maximum working volume range of the specifications. The drain tube is attached to the back of the instrument and the user should ensure that this is not kinked, blocked or obstructed in any way and is of sufficient length to reach the drain container and to stay in place. The drain container should be sited in a position where the tube readily drains into it. In addition, the drain container should be of sufficient volume to contain any fluid that may need to be collected and be used at all times when the XTRX500 is being operated.

In the event of a solvent spill the user should clear this up in line with the Standard Operating Procedure following Good Laboratory Practice (GLP).

A. Introduction


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

A. Introduction


Recommendations for Using This Manual

Teledyne Hanson 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 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 any questions on how to properly operate and maintain the sample preparation extractor.

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.



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)



General safety statements Intended Use The sample preparation extractor (XTRX500) is a semi-automated sample preparation unit for improved repeatability over traditional methods and intended for sample preparation in the process of further analysis. The XTRX500 is thus intended to be a tool for use by laboratory scientists to release their time from the existing process, but not to replace their involvement or their responsibility. As such, correct functioning of the dissolution process as a whole relies not just on the XTRX500, but also involves normal laboratory functions and responsibilities, such as, method validation, standard operating procedures (SOP’s), operator diligence and decision-making, etc. When used with volatile and flammable extraction solvents the XTRX500 should be operated in a fume cupboard. It is recommended as best practice that XTRX500 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 Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The user should be aware that if the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment might be impaired. When using the sample preparation extractor, follow the generally accepted procedures for quality control and method development. When using the sample preparation extractor in the field of solid dosage form analysis, if a change is observed in resultant data compared to known data, immediately determine the reason for the change(s). Until the cause of a change is determined, do not rely on the analysis.



Electrical hazards Every laboratory instrument has specific hazards, so be sure to read and comply with the following precautions. They will help to ensure the safe, long-term use of the sample preparation extractor. Only use fuses of the type and current rating specified. Do not use repaired fuses and do not short-circuit the fuse holder. It is considered to be best practice to use a power supply protected by RCD trips. The supplied power cord must be inserted into a power outlet with a protective earth contact (ground). When using an extension cord, make sure that the cord also has an earth contact. It is recommended that the XTRX500 external power supply (power brick) is placed away from any area where organic vapor can collect in levels that could cause a potential explosion. Do not change the external 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 damage is suspected. Instead disconnect the power cord and contact a Teledyne Hanson representative for a product evaluation. Do not attempt to use the instrument until it has been evaluated. Electrical damage may have occurred if the sample preparation extractor shows visible signs of damage, exposure to any liquids or has been transported under severe stress. Damage can also result if the instrument is stored for prolonged periods under unfavorable conditions (e.g. subjected to heat, water, etc.). In any case, disconnect the power cord(s) from the power supply or from the different power supplies if optional devices are installed before attempting any type of maintenance.



Capacitors inside the instrument may still be charged even if the instrument is turned off. The instrument includes a number of integrated circuits. These circuits may be damaged if exposed to excessive line voltage fluctuations and/or power surges. Never try to repair or replace any components of the instrument that are not described in this manual without the assistance of a Teledyne Hanson representative. There are no operator-serviceable or replaceable parts inside the power supply or in the sample preparation extractor. If a power supply is not functioning, contact a Teledyne Hanson representative. The power cord must be plugged into the instrument before it is switched on at the mains. The instrument should not be used if the power cord is damaged in any way, regular inspection of the power cord is recommended. The instrument must be switched off 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 operators take care when operating the XTRX500 and follow safe practices. The operator should never put their fingers or hands near any moving parts or parts that can move whilst the unit has power. Always switch the unit off and unplug the power lead before cleaning or maintenance. Do not operate the sample preparation extractor without an extraction pouch in place. The extraction pouch must be inserted correctly for safe operation. To avoid injury, observe safe laboratory practice when handling solvents, changing the extraction pouch, or operating the sample preparation extractor. Know the physical and chemical properties of the solvents in use. See the Material Safety Sheets from the manufacturer for the solvents in use.



Use caution when working with the sample preparation extractor:

Always wear eye protection when using the sample preparation extractor.

Use only Hanson supplied extraction pouches. Do not use extraction pouches that have been severely

stressed or used. o The extraction pouches are compatible with

commonly encountered solvents used for HPLC such as, organic alcohols, acetonitrile, organic acids, water and aqueous buffer solutions. The extraction pouches should not be used with chlorinated organic solvents, concentrated mineral acids, such as nitric, phosphoric or sulfuric acids, or any compounds related to the above listings. In addition, non-polar solvents such as hexane and related hydrocarbons should not be used in the XTRX500 pouches. Also, do not use highly volatile materials such as ether or similar solvents. All solvents used must be at ambient temperature and not heated. The system 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. Extraction pouches are single-use consumables and must not be used more than once. It is considered to be best practice to store the XTRX500 with the cassette in place. The case work should be inspected periodically to ensure that no damage has been sustained. In the event of any damage contact a Teledyne Hanson representative before continuing to use the XTRX500. Care should be taken when loading and unloading the cassette from the XTRX500 unit. Do not use excessive force as this can puncture the extraction pouch and cause leaks. To prevent damage to the XTRX500 and XTRX500 software only Teledyne Hanson approved devices should be connected to the instrument via the data port. This port should not be used for charging mobile phones or other devices.



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.

C. Installation

46-208-208 Rev. B—XTRX500 User Guide C-1

XTRX500 Installation

Review all safety instructions before proceeding with installation of the XTRX500.

The XTRX500 must be installed and properly set up before the operating instructions can be used.

Position of the XTRX500 instrument

The XTRX500 must be placed such that the operator has ready access to the power inlet in case they need to disconnect the instrument.

Services requirements

Waste: The XTRX500 does not produce waste liquid during the extraction process. The type and amount of solvent used is specific to the extraction method chosen. The user should ensure that 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 laboratory environments and the user’s in-house Standard Operating Procedures.

Instrument support: The XTRX500 weighs approximately 12 kg (26 lbs.), therefore, no special support is required.

Liquids handling: It is recommended that any solvents and liquids used for the extraction process are handled and disposed of in a safe manner in line with the users’ in-house SOP’s.

Operator chairs: If required, the user should provide chairs for operators.

C. Installation

46-208-208 Rev. B—XTRX500 User Guide C-2

Setup

The sample preparation extractor is a standalone instrument that does not require any special setting up. The user should ensure that surface the XTRX500 is placed on is sturdy enough to ensure that the instrument is stable during normal operation. A drain tube is provided in the unlikely event of pouch failure. This is connected to the back of the XTRX500 and the receiving container should be of sufficient volume and not too full to accommodate any solvent from a burst pouch.

The user 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 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.

Moving the XTRX500

Moving the XTRX500 is a straightforward procedure as the XTRX500 is a portable instrument and weighs approximately 12 kg (26 lbs.).

D. Operation

46-208-208 Rev. B—XTRX500 User Guide D-1

Operation

Please review and follow all safety and installation instructions before operating the XTRX500

Using the XTRX500 NOTE: The operating instructions are intended for infrequent users of the XTRX500 or new users that are experienced in using automated systems to perform existing analytical methods.

NOTE: The XTRX500 must be installed and set up properly before the operating instructions can be used

NOTE: Before running the 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 has a minimum working volume of 100 mL and a maximum of 500 mL. Using the extraction pouch outside of the specific volume range for that consumable will result in poor performance and if too much solvent is added then a leak will occur.

100 mL extraction pouch 500 mL extraction pouch

D. Operation


NOTE: Before adding any solid sample to the extraction pouch, it is extremely important to ensure that the jaws of the extraction 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.

D. Operation


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

D. Operation


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

D. Operation


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.

D. Operation


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

D. Operation


Step 2 – Offer up the 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

D. Operation


Step 3 – Ensure the slot on the top tab of the extraction 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

D. Operation


Step 3 (continued)

Smooth the extraction pouch into Raise the extraction pouch place in the cassette mounting bracket

D. Operation


NOTE: It is essential to ensure the extraction pouch is correctly placed in the XTRX500 cassette and that the cassette is loaded 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

D. Operation


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

D. Operation


Step 6 – The cassette is then loaded onto the XTRX500, when located correctly the barcode reader will illuminate and read the barcode on the extraction pouch.

NOTE: Do not force the cassette into place, excessive force can damage the instrument and/or extraction pouch and 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 process. Details of running Immediate Mode and creating and running new methods can be found in section E (Sample Preparation).

D. Operation


Step 7 – Once the extraction is complete the cassette is removed from the XTRX500 as shown. The action 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

D. Operation


Step 8 – Once the solvent lifter tool is fitted correctly, it is screwed in until the solution level is at the top of the extraction pouch, care should be taken not to raise the solution level too far and avoid spills.

Clip the solvent lifter tool to 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 that not more than 2000 mL should be put on the pouch stand at one time using the small ring only.

D. Operation


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

D. Operation


Step 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

D. Operation


Step 10 (cont.) – The extraction pouch can now be carefully removed from the cassette.

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.

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



Immediate Mode

Running samples using Immediate Mode.

Step 1

From XTRX500 home/start up screen 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.



Step 3

Mixer: The main mixer can be selected from 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 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 much solvent is used for the 100 mL extraction pouch then an error screen is shown when Run is selected.



The maximum amount of solvent that can be used in the 100 mL extraction 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.



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.

When the run is either stopped or comes to completion the XTRX500 mixer bar returns to the home position. A run can be stopped and 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 can be caused by solid between the plates.

If the run is resumed, then the run continues and at completion displays the Pouch Status screen.



The run can be stopped and resumed as many times as required. From the Pouch Status screen either New Event or Finished can be selected.

If Finished is selected, then the XTRX500 returns to the home/start up screen.

If New Event is 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 the Immediate Mode, Cancel is selected and the XTRX500 returns to the home/start up screen.



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.



Step 3

From the Edit Method menu, the XTRX500 automatically names a new method as NEW METHOD 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.



Step 5

Initial Solvent: The volume of the first solvent used is then 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 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 extraction pouch is 100 mL.



It is possible for the XTRX500 to perform a dry crush on the sample. To do this from the Methods Menu

Select:

+Add Method

Edit Method

Initial Solvent 0 mL

Crusher On

Mixer Off

Step 6

Events: Selecting Events goes to the Action Event menu

NOTE: A maximum of 30 events can 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 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 10

Add Event.

Selecting Add Event saves the event data already inputted and goes to Add Event screen

Step 11

In the Add Event menu the option of adding another action event 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 menu there is the option to Delete Event.



Step 12

A maximum of 30 events can be used in one method. Once the required number of events have been added to a method, depressing the back button twice takes the XTRX500 to the Edit Method menu. The new method 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 option is obtained by scrolling down the screen and is below the Delete option).



View: Allows the user to 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.



If an extraction pouch that has already been used in a run is reinserted into the XTRX500 for another, different, run an error message is displayed.

If this error message is shown the extraction pouch cannot be used for the run selected and a new extraction pouch must be 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 events. The method is edited as detailed in Steps 3-13 above.

In the Method Action menu, selecting Copy allows a method to be copied.



The Copy Method menu allows the user to copy a method directly or to edit the name and events of the method selected and to save under a different name. This allows for the quick copying, editing and saving of existing methods already 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 is accessed by scrolling down the Method Action screen using the rotary encoder switch/dial.



Connecting a USB memory stick to the XTRX500

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.



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.



When Lock Methods 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.



If the password 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.



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.



About

Selecting About in the options menu displays the About XTRX500 screen.



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.

F. Maintenance

46-208-208 Rev. B—XTRX500 User Guide F-1

Maintenance The XTRX500 should only be used with Hanson supplied extraction pouches.

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.

G. Troubleshooting

46-208-208 Rev. B—XTRX500 User Guide G-1

Troubleshooting

The sample preparation extractor may represent one of several components in the laboratory process of the analysis. The following guide is limited to the XTRX500 only. Below are a set of commonly encountered error messages, their possible cause and recommended action. If any other error messages are received, then the user should contact a Teledyne Hanson representative.

Symptom or Error Message Possible Causes Recommended Action

Error 001d: Not enough solvent for good mixing.

Not enough solvent used in the extraction pouch to ensure good mixing. 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.

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 pouch is not new

The extraction pouch loaded into the XTRX500 has already been used for an extraction

Use a new extraction pouch.

Error: Failed to set password

The set password is not confirmed correctly.

Repeat the password entry with the correct password. If the password is lost or forgotten, then the user should contact a Hanson representative.

Error 003: No cassette loaded

The user is trying to run the XTRX500 without a cassette in place or the cassette is not seated correctly.

Ensure the cassette is loaded and seated correctly on the XTRX500.

G. Troubleshooting

46-208-208 Rev. B—XTRX500 User Guide G-2

Error 004: Failed to lock The cassette is in place but not located correctly.

Remove the cassette and reload, ensuring it is seated correctly.

Error 001f: Wrong pouch type loaded

A method for a 100 mL extraction pouch is trying to be run with a 500 mL extraction pouch loaded in the XTRX500, or vice-versa.

Ensure the correct extraction pouch size is loaded into the XTRX500 for the method selected.

Error 0029: Extraction pouch missing or not recognized

The user is trying to run the XTRX500 without an extraction pouch in place or the extraction pouch is misaligned.

Ensure an extraction pouch is loaded into the cassette. If the extraction pouch is misaligned, remove the extraction pouch and refit it into the cassette ensuring it is aligned correctly.

Error 002e: Pouch already completed 30 events

The user is trying to run more than 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 from the XTRX500 after the cycle is complete

The sample is not completely extracted and there is solid material between the jaws of the extraction pouch.

Run the cycle for longer to ensure that the sample is completely dissolved and no residue is left between the jaws of the extraction pouch.

The XTRX500 barcode reader is unable to correctly read the barcode on the extraction pouch and does not allow the dissolution to proceed.

The bulk of the sample at the top of the extraction pouch causes the barcode to misalign, meaning that the barcode reader cannot scan the barcode correctly.

Move the sample slightly in the top of the extraction pouch until the barcode is scanned correctly.

H. Specifications

46-208-208 Rev. B—XTRX500 User Guide H-1

Sample Preparation Extractor Specifications

Size (L x W x H): 302 mm x 313 mm x 510 mm

Weight: 12 kg (26 lbs.)

Extraction pouch volume: 25 mL – 100 mL

100 mL – 500 mL

Extraction pouch material polypropylene

Equipment Ratings

Input: 50 – 60 Hz, 100 – 240 V

Input fuse rating: 250 V, 2 AT

Input connections: Mains IEC 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

User Modes

Walk up quick run mode: No method required

Method Mode: Select existing method

Edit Mode: Create, edit, remove methods

Display

Color (RGB) 320 x 240

H. Specifications

46-208-208 Rev. B—XTRX500 User Guide H-2

Software

Software: XTRX500 Command Embedded Firmware

Environmental

Environmental: Reduced solvent for dissolution, no glassware or cleaning, quick extraction/dissolution reduced power consumption

Part Numbers

SAMPLE PREPARATION EXTRACTORS

46-201-221 XTRX500 Sample Preparation Extractor with 1000x 100 mL Pouches

46-201-222 XTRX500 Sample Preparation Extractor with 1000x 500 mL Pouches

46-201-223 XTRX500 Sample Preparation Extractor with 500x 500 mL and 500x 100 mL Pouches

Each extractor includes a startup kit containing 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

CONSUMABLES

46-201-202 XTRX500 500 mL Extraction Pouch (Pack of 100)

46-201-203 XTRX500 100 mL Extraction Pouch (Pack of 100)

46-201-209 Syringe, 20 mL (Pack of 48)

46-201-219 Syringe, 10 mL (Pack of 48)

QUALIFICATION DOCUMENTS

46-208-205 Q-Pak Validation Guideline

For further information, please contact your local Teledyne Hanson representative or email us at [email protected].

I. General Warranty

46-208-208 Rev. B—XTRX500 User Guide I-1

General Warranty Teledyne Hanson is a division of Teledyne Instruments, Inc. Teledyne Hanson products are warranted for one full year including parts and labor. Service contracts and preventive maintenance contracts are available for post-warranty support. International dealer warranties may vary. Teledyne Hanson makes no warranty, expressed or implied, 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 expressed or implied, if the product covered is repaired or modified by other than its own personnel, or without written authorization from Teledyne Hanson. There are no other warranties, expressed or implied, and Teledyne Hanson shall not be liable under any circumstances for damages of any kind, direct, consequential, or otherwise.

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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