Chromatography Data System: Getting It “Right First Time” Seminar Series – Part 3

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    10-May-2015

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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 - No reprocessing data or re-running injections - No out of specification (OOS) results or reporting/calculation errors Using chromatography tools for 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)

Transcript

1.1 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 2. 2 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 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 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 8. 8 Sequence Ready Check 9. 9 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 10. 10 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 11. 11 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 12. 12 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 13. 13 Smart Startup 14. 14 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 15. 15 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 16. 16 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 17. 17 Smart Startup Parameter status is monitored and updated in real time 18. 18 Smart Startup 19. 19 Smart Startup 20. 20 Smart Startup 21. 21 Smart Startup 22. 22 Smart Startup 23. 23 Smart Startup 24. 24 Smart Startup 25. 25 Smart Startup 26. 26 Smart Startup Once everything is within specification sequence starts 27. 27 Smart Startup Customization Smart Startup conditions are automatically extracted from Instrument Method Easily accessible in Instrument Method Editor via dedicated tab 28. 28 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 29. 29 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 30. 30 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 31. 31 Live Demo Lets have a look at the Ready Check and Smart Startup in action 32. 32 Summary 33. 33 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 34. 34 Next time Discover even more Chromeleon CDS tools to ensure you get right first time, every time analysis 35. 35 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

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