Teledyne XTRX500 Bedienungsanleitung

XTRX500

AMPLE

REPARATION

XTRACTOR

SER

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: hansontechsupport@teledyne.com

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

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).

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