Teledyne XTRX500 User manual

XTRX500
S
AMPLE P REPARATION E XTRACTOR
U
SER G UIDE
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: [e-mail]
Phone: [phone]
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
46-208-208 Rev. B—XTRX500 User Guide A-2
Sample Preparation Extractor Overview
Sample preparation extractor (XTRX500) system description.

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

A. Introduction
46-208-208 Rev. B—XTRX500 User Guide A-4
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
46-208-208 Rev. B—XTRX500 User Guide A-5
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
46-208-208 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

A. Introduction
46-208-208 Rev. B—XTRX500 User Guide A-7
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.

B. Regulatory and Safety
46-208-208 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)

B. Regulatory and Safety
46-208-208 Rev. B—XTRX500 User Guide B-3
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.

B. Regulatory and Safety
46-208-208 Rev. B—XTRX500 User Guide B-4
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.

B. Regulatory and Safety
46-208-208 Rev. B—XTRX500 User Guide B-5
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.

B. Regulatory and Safety
46-208-208 Rev. B—XTRX500 User Guide B-6
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.

B. Regulatory and Safety
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.

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.