1. The document discusses tools in Thermo Scientific's Chromeleon Chromatography Data System for ensuring analytical results are "right first time" without needing reprocessing or re-running injections. 2. It describes the Sequence Ready Check, which verifies sequences will run correctly by checking for issues before and during runs, and the Instrument Method Check, which identifies issues with instrument methods. These help labs achieve more right first time analyses. 3. Smart Startup is also covered, which automates instrument initialization and equilibration to ensure the first injection is valid, reducing wasted time and resources compared to manual equilibration. It aims to remove subjectivity and aid in efficient method switching.

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The world leader in serving science
Darren Barrington-Light
Product Specialist, Chromatography Software,
Thermo Fisher Scientific
May 21, 2014
Getting It “Right First Time”
Seminar Series – Part 3
PP71148_E 04/14S

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Agenda
• Introduction
• How to get it right the first time
• Thermo Scientific™ Dionex™ Chromeleon™
Chromatography Data System (CDS) tools for RFT analysis
• Sequence Ready Check
• Smart Startup
• Summary

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Introduction
• Modern business drivers are continually pushing to reduce the
time it takes to get a product or service to market, reduce the
risk and cost associated with that, and to improve quality
• In laboratories, delivering an analytical result that’s ‘right first
time’ (RFT) is the answer
• No reprocessing data or re-running injections
• No out of specification (OOS) results or reporting/calculation errors
• Getting RFT analysis automatically gives:
 High quality of results and confidence in results
 Lower cost of analysis
 Improved lab efficiency
 Faster release to market and return on investment (ROI)

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How to Get It Right the First Time?

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How to Get It Right the First Time?
• Robust and reliable instrumentation
• Qualification automation
• Monitor instrument status
• Robust, reproducible, and reliable methodology
• Standard operating procedures
• Method validation
• Automated sequence creation
• Run-time checks
• In-run reactions to actual chromatographic results
• Automated result calculation and export
• Operators
• Make learning curve as shallow as possible
• Provide tools to help inexperienced users with more complex tasks

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Chromeleon CDS Tools for RFT Analysis

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Chromeleon CDS Tools for RFT Analysis
• Instrumentation
• Predictive performance – instrument qualification, service and wear part
monitors
• Methodology
• ICH Method Validation Templates
• eWorkflows™
• Sequence Ready Check
• Smart Startup
• System Suitability Tests with Intelligent Run Control
• Spreadsheet-based Report Designer with integral Report Check
• Operators
• All the above combine to ensure ANY operator can achieve RFT
analysis

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Sequence Ready Check

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Sequence Ready Check
• How do you know that the sequence you have just created
will run without any problems? What if you add injections
during the run or modify the Instrument Method? If there are
issues, how do you identify them?
• Sequence Ready Check verifies that:
• Sequence list contains valid vial positions and methods
• Instrument is ready for operation
• Instrument Methods used to run each injection of every sequence in the
Queue are error free
• Any Injection Custom Variables used in Instrument Method are valid
• Instrument Method Check verifies that all Instrument Method
entries are valid

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Sequence Ready Check
• Runs automatically
• When Queue is started
• Before each injection
• If sequence is added to running Queue
• Run manually at any time
• Results only shown if issues found
• Abort – must be corrected
• Error – must be corrected
• Warning – should be corrected
• Information – info only
• e.g. eluent volume required

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Instrument Method Check
• Automatic checks inside Instrument Method Editor ensure
only valid methods can be saved
• Incorrect entries are clearly highlighted and described
• Method tabs cannot be exited with incorrect entries

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Right First Time Analysis
• Sequence Ready Check
• Identifies problems with sequence before run starts and during run
• Works for all sequences and instruments
• Instrument Method Editor Check
• Identifies and highlights issues with Instrument Method
• Works for all methods and instruments
• Ensure only valid sequences and methods can be
run or added to Queue
• More right first time analyses

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Smart Startup

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Smart Startup
• How do you know your instrument is ready to perform the
analysis? Which settings do you need? How long should you
wait for it to equilibrate? Ever left your system equilibrating
for ages?
• Usually left to analyst to decide - subjective. Often equilibrate too long or
add extra ‘sacrificial’ injections wasting solvent, sample, vials and time.
• Smart Startup initializes and equilibrates your instrument with
correct chromatographic conditions before first injection.
Start your sequence with
‘Start with Smart Startup’

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Smart Startup
• Available for Thermo Scientific™ Dionex™ UltiMate™ 3000
HPLC and modular Thermo Scientific™ Dionex™ ICS systems
• Dedicated ePanel provided for Smart Startup
• Set Smart Startup per sequence in Queue tab
• Can simplify automation of method switching
• Can set delayed start

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Smart Startup
• First runs instrument wake up routine
• Ensures modules are active and connected
• Next prepares instrument
• Purges pump, runs gradient wash, flushes system
• Washes autosampler
• Switches column oven valves
• Heats or cools temperature-controlled modules
• Switches lamps on
• Finally sets initial conditions for all modules and equilibrates
• After 10 min warm up, key parameters are monitored
• Pump pressure ripple
• Sampler and oven temperature
• Detector noise and drift

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Smart Startup
• Parameter status is monitored and updated in real time

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup

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Smart Startup
• Once everything is within specification sequence starts

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Smart Startup – Customization
• Smart Startup conditions are automatically extracted from
Instrument Method
• Easily accessible in Instrument Method Editor via dedicated
tab

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Smart Startup – Customization
• Can select whether to startup specific modules and perform
certain procedures
• Purge pump
• Flush system
• Set temperatures
• Lamps/cells on
• Electrolytic devices on
• Can access advanced
settings for finer control

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Smart Startup – Customization
• Can edit all settings including
acceptance criteria
• Pump pressure ripple limit
• Noise & drift limits
• Temperature limits
• Maximum equilibration time
limits time for system to
reach equilibration before
stopping Smart Startup

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Smart Standby and Shutdown
• Smart Shutdown
• Safely shuts system down
• Can flush system to remove buffers
• Switches off
• Flow
• Detector lamps/cells
• Electrolytic devices
• Ovens
• Smart Standby
• Automatically puts system into
standby mode
• Low flow, lamps off, lower temps
• Set in the Queue

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Live Demo
• Let’s have a look at the Ready Check and Smart Startup in
action …

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Summary

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Summary
• Sequence Ready Check and Instrument Method Check
• Checks that every sequence will run correctly and discovers any issues
before and during the run
• Identifies and highlights issues with Instrument Method
• Works for all sequences, methods and instruments
• Ensures only valid sequences and methods will be run giving more right
first time analyses
• Smart Startup:
• Automates your instrument initialization and equilibration
• Ensures first injection is always good
• Removes subjectivity from system readiness and frees up analyst time
• Eliminates wasted solvent, sample and run time
• Aids method switching increasing instrument utilization

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Next time…
• Discover even more Chromeleon CDS tools to ensure you
get “right first time, every time” analysis

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For more information about Chromeleon 7.2 CDS or
to request a Demo CD, visit:
thermoscientific.com/Chromeleon
Like Charlie Chromeleon on Facebook to follow his travels and
get important updates on chromatography software!
facebook.com/CharlieLovesChromatography
Thank you for listening