Chromatography Data System: Getting It “Right First Time” Seminar Series – Part 4

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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 thats 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).


1.1 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 thats 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) 4. 4 How to Get It Right the First Time? 5. 5 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 6. 6 Chromeleon CDS Tools for RFT Analysis 7. 7 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 8. 8 System Suitability Tests 9. 9 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 10. 10 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 11. 11 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 12. 12 System Suitability Tests Easily create multiple tests Identify test injections Define evaluation parameters Select required test type Customize parameters Select test component(s) 13. 13 System Suitability Tests Create complete set of tests Can directly view test results In Processing Method In report 14. 14 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 15. 15 Intelligent Run Control 16. 16 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 17. 17 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 18. 18 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 19. 19 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 20. 20 Configure pass and/or fail actions multiple actions are possible Intelligent Run Control Specify multiple actions Select required action 21. 21 Intelligent Run Control Error handling for a failed execution allows user to continue to next action/test case/injection or abort 22. 22 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 23. 23 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 24. 24 Intelligent Run Control Example: Re-inject check standards if Peak Area RSD fails 25. 25 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 26. 26 Live Demo Lets have a look at SST and IRC in action 27. 27 Summary 28. 28 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 29. 29 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 30. 30 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 31. 31 Discover even more Chromeleon CDS tools to ensure you get right first time, every time analysis Next time 32. 32 For more information about Chromeleon 7.2 CDS or to request a Demo CD, visit: Like Charlie the Chromeleon on Facebook to follow his travels and get important updates on chromatography software! Thank you for listening


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