An Introduction to:

Thermo Scientific Dionex Chromeleon 7

Chromatography Data SystemChromatography Data System

• Introducing

• User Interface

• Peak Detection Tools

• eWorkflows™

• Interactive Charting

• Data Mining

• Reporting

Agenda

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• Reporting

• Intelligent Run Control

• Fraction Collection

• Mass Spectrometry

• Support for Third Party Instrumentation

• Networking Capabilities

• Summary

Introducing Chromeleon 7 Chromatography Data System

• New-generation Thermo Scientific™ Dionex™ Chromeleon™ Chromatography Data System (CDS)

• “Simply Intelligent”

• Intelligent Functionality - it does everything you need!

• Operational Simplicity™ - everything is fast and easy!

• Simplifies all chromatography processes

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Operational Simplicity

• Operational Simplicity was the core design principle

• Major design rules:

• Minimize number of steps needed to perform any task

• Make all steps easy to understand and easy to use

• Minimize time needed to perform any task

• Major features for Operational Simplicity:

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• Modern user interface

• Peak detection and integration tools

• eWorkflows

• Data visualization tools

• Enterprise functionality

USER INTERFACE

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User Interface

• The Chromeleon CDS User Interface consists of two major parts:

• Chromeleon CDS Console

• Designed to provide easy navigation through your data

• Chromatography Studio

• Used for All Data Evaluation

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Console - Easy Access to Data

Navigation Pane

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Category Bars

Console - Easy Access to Data

Integrated

sequence editor

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MiniPlots™

Console – Easy Access to Instruments via ePanels

Provides access to

all instruments on

the network

Immediate access

to Audit Trail

and Queue

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ePanels are auto-generated for each instrument.

the network

Chromatography Studio – Data Processing and Reporting

Ribbon

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Navigation Pane

Category Bars

PEAK DETECTION

COBRA Peak Detection Algorithm / SmartPeaks Integration Assistant

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Peak Detection

• Most time consuming and tedious task in chromatography process

• Chromatogram Integration

• Chromeleon 7 CDS introduces two new tools to simplify this process

• Cobra™ Peak Detection Algorithm / Wizard

• SmartPeaks™ Integration Assistant

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Peak Detection – Cobra

• Cobra is a new algorithm that:

• Finds peak start and end times accurately and consistently

• Requires minimum number of parameters to reach integration goals

• Cobra Wizard provides:

• Fast, guided way to determine initial detection parameters

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Peak Detection - SmartPeaks

• Unique tool for easily reaching your integration goals for unresolved peaks

• Requires no training

• Great example of Operational Simplicity

• Process is clear and understandable

• Requires only a few steps

• Correctly integrates all unresolved peaks in seconds

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SmartPeaks – A Revolution in Ease of Use

• There are many ways to integrate unresolved peaks

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Is this what

we want?

Is this what

we want?

SmartPeaks Integration Assistant

1. Activate SmartPeaks Wizard

2. Select Area of Interest 3. Select the Integration You Want

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SmartPeaks Integration Assistant

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And Your Integration Is Done!

eWORKFLOWS

The Ultimate in Operational Simplicity

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eWorkflows – From Samples to Results

• eWorkflows™ take you from Sample to Results in the minimum number of steps

• Fully customizable for any application

• Minimum amount of training required

• Reduces errors and produces results faster

• A new framework for Operational Simplicity

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eWorkflow for a Regulated USP/EP Method

3. Sequence is created and

can be immediately run

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1. Choose

eWorkflow, Select Instrument, and

Click “Launch”2. Enter Number of

Samples and Start Position

eWorkflow for a Regulated USP/EP Method

This eWorkflow also:

• Processes all data

• Calculates all results

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From Sample to Result in the Shortest Time Possible

eWorkflows

• eWorkflows to boost lab productivity - typically 30-50% time savings

• Applies to all laboratories, for example:

• QA/QC laboratories

• Method development laboratories

• Research & Development laboratories

• Walk-up instrument workflows

• Built-in Templates for Key Pharma Applications

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• Built-in Templates for Key Pharma Applications

• GPC

• ICH Method Validation

• Dissolution Testing

• Content Uniformity Testing

INTERACTIVE CHARTING

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Data Visualization

• Interactive Charts for Data Visualization

• Fully customizeable

• Templates for the most common tasks

• Available for both on-screenand printed/exported reports.

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Interactive Charting

Various Chart types

Pie Chart 2D / 3D

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Stacked Column 2D / 3D

Scatter Plot

DATA MINING

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Data Mining Tools

• Queries can be executed to find any injection, or group of injections.

• Search fields include any sample criteria or any calculated result!

Example:

• Find all Standards

• Injected on HPLC_System_13

• During the previous 6 months

• Using Instrument Method TM122

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• Using Instrument Method TM122

• With a peak name containing Methyl

Data Mining Tools

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Search criteria are entered

into a simple interface….

Data Mining Tools

Query results are

immediately displayed

as a Virtual Sequence

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Data Mining Tools

• Example: Samples injected over a 3 year period for a stability study

• Samples can be located, in this case Lot Number is used

• Once the data is located it can be compared as if it belongs to the same

sequence:

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Data Mining Tools

• Using Excel-like functionality the report table can immediately indicate a Pass or Fail result:

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Data Mining Tools

• The data can also be viewed graphically in charts:

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G367

G367 6 Mo

G367 12 Mo

G367 18 Mo

G367 24 Mo

G367 36 Mo

Here the active

ingredient is shown

degrading over time

Data Mining Tools

• The data can also be viewed graphically in charts:Rel.Area (Imp_1)

And the Relative Area

of the impurity over the

same time period

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G367

G367 6 Mo

G367 12 Mo

G367 18 Mo

G367 24 Mo

G367 36 Mo

Example: Column Performance

• Charting column performance throughout a sequence, or multiple sequences over a period of time:

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Interactive Charting: Examples

Instrument Utilization

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REPORTING

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Spreadsheet Based Reporting

• The Excel-like report environment is both familiar and intuitive

• If Excel is used for additional calculations they can be included in Chromeleon CDS

• No data transcription or

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• No data transcription or export to Excel is required

• Results are generated instantly

Spreadsheet Based Reporting

Excel-like formulae can be included for custom

calculations

In this case the operator has configured a report to flag

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configured a report to flag out of specification results.

Report Designer - Functions

Many Excel-like functions available – use identical syntax

AVERAGE

IF / AND / OR

STDEV

COUNT

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COUNT

SUM

LOOKUP

etc……

INTELLIGENT RUN CONTROL

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Intelligent Run Control

• Chromeleon 7.2 CDS automates injection decisions, based on previous results and chromatographic specifications

• Improves analytical efficiency

• Improve or standardise product quality

• Reduces solvent & analyte use

• Reduces results review process

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Intelligent Run Control

Examples:

• Component Carry Over

• Test : Is area of Peak A < 5 mAU/min for a Blank Injection?

• Pass Action: continue

• Fail Action: add Blank injection to sequence, and inject

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• Automatically Dilute a Sample (AutoDilution)

• Test: Is a component concentration within the tolerated range?

• Pass Action: continue

• Fail Action: dilute the sample, insert an injection into the

sample list and re-inject.

Intelligent Run Control

• Example of an Unconditional Action

• Set the desired action and then set properties for that action

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FRACTION COLLECTION

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Fraction Collection

• Chromatogram Plot - capable of showing tube stripes

• Rack View – shows the collected fractions and the fraction details

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• Wizard/Editor for Fraction Collection

• Straightforward setup of fraction collection parameters

• Preview of fractionation using an existing chromatogram

Fraction Collection

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MASS SPECTROMETRY

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MS is fully integrated within Chromeleon 7.2 CDS

• Chromeleon 7.2 CDS supports MS instrument control and data processing in an enterprise environment.

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Chromeleon Goes MS

• Enables existing Chromeleon CDS functionality for GC-MS and LC-MS

• Client/server, central data storage + 21 CFR Part 11/GLP/GMP compliance

• Extends Data Processing to support typical MS quantitation workflows

• Multiple dynamically linked Data Views and Component Traces

• Support for multi-channel MS quantitation

• Library searches, versioning and charting

• Industry leading Reporting tools

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• Industry leading Reporting tools

• Manage entire laboratory centrally from 1 CDS: LC/IC/GC/MS

SUPPORT FOR THIRD PARTY INSTRUMENTS

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Instrument Control

• Chromeleon 7 CDS can control Thermo Scientific LC, GC, IC and MS.

• Chromeleon 7 CDS can control 3rd Party LCs and GCs

• Agilent 1100, 1200, 1260, 1290, G1888, 6850,

6890, 7890

• Waters Acquity, Alliance

• Shimadzu LC10, LC2010, LC20, LC30,

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• Shimadzu LC10, LC2010, LC20, LC30,

GC2010/2014

• Perkin Elmer 200, Clarus, Autosystem XL

• CTC PAL

• Gilson and Varian LC

• And many more.....

NETWORK CAPABILITIES

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Chromeleon CDS Installation

• Can consist of a single computer used for controlling one or two instruments and data processing

• Instruments are Thermo Scientific LC, GC or IC, Third Party GC or Third

Party LC

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• Or of a network…

• … with multiple computers and instruments …

• … clients to process data or remotely control instruments …

• … and a central location to directly store all chromatography data

Chromeleon Domain

Chromeleon CDS Installation

Chromeleon Domain

Controller

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Network

Central

Server

SUMMARY

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Chromeleon 7 CDS – Simply Intelligent

• Contains the Intelligent Functionality needed to generate the result!

• Uses Operational Simplicity to minimize the steps and time needed to generate the result!

• Offers state-of-the-art technology:

• Modern User Interface

• Peak detection and integration tools

• eWorkflows – THE framework for Operational Simplicity

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• Advanced Interactive Charting

• Advanced Reporting

• Intelligent Run Control

• Control of GC, IC, LC, MS and Third Party Instrumentation

• Full Network Scalability

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Thank you for your attention!