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. There is no reprocessing data or re-running injections and no out of specification (OOS) results or reporting/calculation errors. Using chromatography data system tools for RFT analysis automatically gives high quality of results and confidence in results, lower cost of analysis, improved lab efficiency, and faster release to market and return on investment (ROI).

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The world leader in serving science
Darren Barrington-Light
Product Specialist, Chromatography Software,
Thermo Fisher Scientific
June 18, 2014
Getting It “Right First Time” Seminar
Series – Part 4: Intelligent Run Control
Part Number:
PP71176_E 06/14S

2. 2
Agenda
• Introduction
• How to get it right the first time
• Thermo Scientific™ Dionex™ Chromeleon™
Chromatography Data System (CDS) tools for RFT analysis
• System Suitability Tests
• Intelligent Run Control
• Summary

3. 3
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 Test (SST) with Intelligent Run Control (IRC)
• 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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System Suitability Tests

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System Suitability Tests
• USP Chromatography General Chapter:
• "System suitability tests (SST) are an integral part of gas and liquid
chromatographic methods. They are used to verify that the resolution
and reproducibility of the chromatographic system are adequate for the
analysis to be done. The tests are based on the concept that the
equipment, electronics, analytical operations and samples to be
analyzed constitute an integral system that can be evaluated as such.“
• Ensure performance of complete testing system (including
instrument, reagents, and columns) is suitable for intended
application on a day-to-day basis
• System must pass set of predefined acceptance criteria before sample
analysis can commence
• USP and ICH guidelines are “bibles” followed closely by industry

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• Commonly used to verify, for example:
• Peak resolution
• Column efficiency
• Peak asymmetry
• Injection repeatability
• Capacity factor
• Signal-to-noise ratio
• Standard correlation
• Performed before and throughout analysis
• Data acceptance criteria describe limits used to accept or
reject analytical data
• Represent minimum acceptable system performance levels
System Suitability Tests

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System Suitability Tests
• Setup SSTs to ensure chromatography quality
• Templates for most common tests
• Evaluate SST results offline
or as samples are analyzed
• Any measurable parameter
can be monitored
• Can also check results against
specifications

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System Suitability Tests
• Easily create multiple tests
Identify test
injections
Define evaluation
parameters
Select required
test type
Customize
parameters
Select test
component(s)

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System Suitability Tests
• Create complete set of tests
• Can directly view test results
• In Processing Method
• In report

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System Suitability Tests
When SST fails:
• “Analyst facing initial SST failure should stop sequence
immediately, before any sample injections have been done, to
avoid having to retest sample”
• Analysis of actual samples should only commence after
system has passed all SST limits, not only failed criteria
• Automation makes this very difficult
• Systems often run unattended overnight
• Analyst sees failure too late
• Most CDS offer SST tools to monitor but what are options
when tests fail?
• Often only abort/continue

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Intelligent Run Control

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Intelligent Run Control
• Can you react to changing conditions during the sequence?
What if your RTs drift or the %RSD is out of spec? Can you re-
inject a bad injection?
• Usually left to analyst to decide – subjective, error prone & often too late.
• Chromeleon Intelligent Run Control (IRC) allows decisions to
be made during run
• Improves analytical efficiency
• Improve or standardise product quality
• Reduces solvent and sample use
• Reduces results review process

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Intelligent Run Control
• Actions evaluated for Pass and Fail tests
• Insert injections
• Re-inject partial or full sequence
• Autodilution
• Perform arithmetic processes
• Extract channels or Optimum Integration Path
from a PDA 3D Field
• Actions performed conditionally or unconditionally

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Intelligent Run Control - Examples
• Component Carry Over
• Test: Is area of main peak < 0.0040 % for a blank injection?
• Pass Action: Continue
• Fail Action: Insert blank injection in sequence, and inject
• RSD of Peak Area
• Action: Calculate RSD of peak area of main peak in 6 SST injections
• Test: Is RSD > 1%?
• Pass Action: Abort
• Fail Action: Continue

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• 2 extra columns are visible in the Processing Method
• Double click any column to edit test
• Access to relevant part of wizard from column clicked
Intelligent Run Control

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• Configure pass and/or fail actions – multiple actions are
possible
Intelligent Run Control
Specify multiple
actions
Select required
action

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Intelligent Run Control
• Error handling for a failed execution allows user to continue
to next action/test case/injection or abort

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Intelligent Run Control
• Example of an Unconditional Action
• Will not be evaluated on test results
• Set desired action and then set properties for that action

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• New IRC action in 7.2 SR1 – AutoDilution
• Customize parameters for re-injection
• Select a different Instrument Method
• Alter any editable injection parameter including Custom Variables
Intelligent Run Control

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Intelligent Run Control
• Example: Re-inject check standards if ‘Peak Area RSD’ fails

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• In-run SST checks to your specification
• High confidence in your results – no reprocessing saves time and effort
• In-run IRC reactions to OOS results
• No need for re-runs – saves time, solvents and consumables
• Fewer OOS investigations – saves time and effort
• Gives more right first time analyses
Benefits of SST with IRC

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Live Demo
• Let’s have a look at SST and IRC in action …

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Summary

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Summary
• System Suitability Tests
• Ensures performance of system on a day-to-day basis
• Can check all aspects of analysis
• Multi-component, multi-parameter testing
• Can check conformance to specification
• Gives confidence in results when all pass
• Intelligent Run Control
• Automates handling of OOS results
• Can react to passed and/or failed conditions
• Multiple conditional or unconditional actions
• Eliminates wasted reinjections, solvent, sample and time
• If sequence completes all tests have passed  results are OK

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Summary
• RFT needs preparation and reproducibility
• Automation where possible
• Chromeleon CDS Software provides:
• Predictive Performance
• Improves instrument utilization and uptime  analysis
more likely to complete first time
• ICH Method Validation Templates
• Ensure method is robust and suitable for the intended
analysis  more likely to run first time
• eWorkflows
• Create complete, correct sequence with predefined files
and well-defined structure  correct sequence first time

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Summary
• Sequence Ready Check
• Ensures all sequences are correctly configured and ready
to run first time  sequence will run to completion
• Smart Startup
• Automatically initializes instrument & sets correct initial
conditions  first injection is always good
• System Suitability Tests
• Check all aspects of analysis including results against
specs  highest confidence in results
• Intelligent Run Control
• Take automated, in-run actions based on actual results
 RFT results, no OOS investigations

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

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For more information about Chromeleon 7.2 CDS or
to request a Demo CD, visit:
thermoscientific.com/Chromeleon
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Thank you for listening