Fusion AE LC Method Development Software

Transcription

1 Fusio AE LC Method Developmet Software S-Matrix

2 Fusio AE Rapid LC Method Developmet The oly automated Quality-by-Desig optimizatio solutio! Automates LC method developmet accordig to rigorous Quality-by-Desig (QbD) guidelies Guaratees reliability by calculatig ad visually cofirmig robust LC method QbD desig space prior to validatio Saves time ad solvets with efficiet experimetal protocols ad automated optimizatio tools I a sigle LC-cetric software platform, Fusio AE delivers a totally automated QbD approach that revolutioizes method developmet from frot to back. Fusio AE seamlessly iterfaces with Waters Empower 2, Agilet ChemStatio, ad Dioex Chromeleo Chromatography Data Systems(CDS) that cotrol HPLC ad UPLC systems. Usig chromatographic data, Fusio AE trasparetly maages complex statistics ad models for method optimizatio. Fusio AE builds experimets, aalyzes data, ad presets results as visual ad umeric method predictios. Seamless Itegratio Fusio AE exports desiged methods ad sequeces directly to the CDS ad imports results data for aalysis ad modelig. Elimiates Laborious Maual Peak Trackig Fusio AE Tred Respose operators elimiate the eed for idetifyig idividual peaks i chromatograms while still geeratig quatitative modelig data. Tred Respose operators track critical peaks uder the varyig experimetal coditios associated with early LC method developmet. Addresses All Istrumet Parameter Effects Fusio AE predicts the optimum LC method after modelig all sigificat effects liear, iteractio, ad complex o each critical method performace characteristic. Statistical egies maximize experimetal efficiecy by determiig the miimum umber of experimets required for valid, defesible results. Presets Easy to Iterpret Results Fusio AE results visualizatio optios iclude: Respose Surface, Cotour ad Effects plots, Numerical Optimizer, Graphical Optimizer, ad Robustess Simulator reports. Brig the best sciece ad productivity to your LC method developmet program with Fusio AE. Visualize Method Performace ad Robustess Fusio AE overlay graphics with color-coded respose surface maps defie the QbD Kowledge, Desig, ad Operatig Spaces. With these spaces defied, users ca automatically predict robust LC method settigs. 2

3 Start to Fiish with Fusio AE Software Quickly desig ad ru automated experimets with a ituitive, template-drive frot-ed Experimetal Desig Template Builder Fusio AE automatically builds ad rus experimets that develop ad optimize LC methods usig stadard or user-customized templates. Study LC istrumet parameters i ay combiatio by simply selectig parameters from the available Variables list. Oce selected, the study rages ad level settigs of the variable are easily etered ito the template. Multiple Experimet Desig Types Icorporatig a systematic QbD approach, Fusio AE automatically costructs the experimetal regio ad selects the most efficiet statistical experimetal desig. Alterative desig types ca be selected i the user-iteractive mode. Available desig types iclude: Full ad Fractioal Factorial, Plackett-Burma, Box-Behke, Cetral Composite, Star, Mixed Level, ad Model-Robust Algorithm desigs. Ready-to-Ru Desiged Experimets Fusio AE automatically icorporates colum washes required for chages i mobile phase factors such as ph, Additive, ad orgaic solvet type. I additio, oe click ca add the followig ijectio types: Blak for baselie moitorig System suitability System shutdow The, a sigle click automatically exports the experimetal desig to the CDS as ready-to-ru LC methods ad sample sets. 3

4 Fusio AE Phased LC method developmet workflow Quickly develop optimized LC methods usig a two-phase workflow. Each phase replaces the qualitative elemets of covetioal Pick the Wier method developmet with statistically rigorous quatitative results. Phase 1 Colum ad Solvet Screeig Rapid screeig experimets study the major effectors of method performace, icludig colum type, mobile phase compositio, ph, ad geeral gradiet coditios. To maximize walk-away experimetatio, Fusio AE automates cotrol of iteral ad exteral colum ad solvet switchig valves. Phase 2 Method Optimizatio Phase 2 experimets use colum ad mobile phase settigs from Phase 1 plus additioal variables with tighter rages to determie the optimum LC method. Fusio AE applies a uique combiatio of Mote Carlo Simulatio ad Process Capability statistics to quatitatively evaluate method robustess without ruig additioal experimets. The Robustess Simulator the idetifies methods that are optimized for both mea performace ad method robustess. Substatial time ad resource savigs are realized by coductig robustess verificatios durig method developmet, prior to method validatio. Oe click creates ad exports experimet desig, LC methods, ad sample sets to CDS Use Template Tool to select Primary effector study variables Major variables are colum type, solvets, ad gradiet. Phase 1 Colum ad Solvet Screeig Oe click starts ad rus LC i Iject ad Forget Mode Correct colum, solvet system, ad approximate gradiet are idetified Oe click starts rapid data import ad visualizatio usig Tred Resposes, ad Numerical ad Graphical Optimizer Fusio AE Use Template Tool to select Secodary effector study variables Secodary variables iclude ph, flow rate, colum temperature, ad gradiet ad time/slope. Oe click creates ad exports experimet desig, LC methods, ad sample sets to CDS Phase 2 Method Optimizatio Oe click starts ad rus LC i Iject ad Forget Mode Complete optimized, robust LC method Robustess Simulator calculates the degree of robustess Numerical Optimizer calculates best predicted method. Graphical Optimizer presets results for viewig ad iterpretatio. Oe click data import, aalysis ad visualizatio with Peak ID ad Tred Respose peak trackig 4

5 Rapid data aalysis with oe click! Elimiate Peak Trackig Durig Screeig Tred Respose operators automatically characterize the quality of the separatio i each chromatogram to elimiate peak trackig. Operators that ca be associated with ay CDScomputed result iclude: Total umber of peaks Number of resolved peaks Max peak area-tracked resolutio Max peak area-tracked symmetry Last peak retetio time Oe click ad Fusio AE statistically aalyzes ad models all critical method performace characteristics, istatly traslatig the Experimetal Regio ito a quatitative Kowledge Space. Data is quickly iterpreted i reports usig graphics for easy visualizatio of results. Visualize Previously Uobserved LC Parameter Iteractio Effects Fusio AE is the oly applicatio to accout for all iteractio effects i chromatographic separatios. Respose surface plots show the combied effects of variables o key chromatographic resposes such as peak resolutio, tailig, ad retetio. Color gradatio represets the magitude of iteractios with curvature idicatig the type of iteractio. Fusio AE automatically aalyzes all the data from respose surface plots ad idetifies regios where methods will optimally perform. Liear Additive 3D Respose Surface Plots Iteractio Complex Quickly Test User-Defied Performace Goals Usig the Numerical Optimizer, LC method performace goals are defied ad raked i order of importace. For each parameter, goals may be set as: Maximize Miimize Target rage The Numerical Optimizer searches for the LC method that meets all performace goals simultaeously. Results are istatly raked ad reported. 5

6 Easy iterpretatio of LC method performace ad robustess with back-ed Graphical Optimizer QbD Kowledge Space Automatically Predict Mea Method Performace Zoe Overlay graphs show method study variable rages that defie the QbD Kowledge Space. Ay combiatio of multiple variables ca be simultaeously studied. Color-coded areas idetify where mea method performace goals are ot met. Ushaded areas correspod to study variable level settigs that exceed all goals for mea method performace. Mea Method Performace Robust QbD Desig Space Quickly Defie ad Verify Robust Method Desig Space Fusio AE itegrates robustess ito the method developmet process without the eed for ay additioal experimets. The Robustess Simulator applies Mote Carlo modelig statistics to automatically geerate robustess metrics for each method performace characteristic. Mea method performace ad robustess models are the liked to establish the QbD Desig Space withi which both mea performace ad robustess requiremets are met. Users ca the easily defie the method Operatig Space, create the associated verificatio rus as methods i the CDS, ad cofirm the validity of the Desig Space. Get the best method possible with Fusio AE. Operatig Space Observe ad Modify Variable Settigs Easily chage ad test variable level settigs, usig slide cotrols to maximize the Desig Space. Chages are istatly visualized i a ew color-coded Overlay Graph. Maximize Laboratory Efficiecy The template-drive Fusio AE frot-ed dramatically reduces the time required to desig experimets ad build idividual LC methods associated with DOE (Desig of Experimets) aalysis from hours to miutes. Fusio AE Tred Respose operators sigificatly speed up post ru data processig ad aalysis. With overlay graphs, aalysts ca quickly idetify, test, ad report regios of optimum method performace ad robustess. Fusio AE delivers better results i less time. Experimetal Desig ad Method Creatio Chromatogram Itegratio ad Data Aalysis Report Geeratio Aalyst Hads-O Time Compariso Total Time Hours Required Fusio AE Covetioal Approaches

7 Why Fusio AE LC Method Developmet... At last, soud statistics ad complete automatio for rapid developmet of robust LC methods Sciece at its best Screes colums ad solvets ad optimizes LC method performace to maximize peak resolutio ad decrease overall ru time Optimizes overall method robustess usig rigorous simulatio modelig ad SPC metrics for successful method trasfer from R&D to QC Iterfaces seamlessly with the Waters Empower 2, Agilet ChemStatio, ad Dioex Chromeleo Chromatography Data Systems that cotrol HPLC ad UPLC systems Scales from a sigle workstatio to a full etwork or Citrix eviromet Desiged for cgxp ad 21 CFR Part 11 eviromets Productivity at its best Meets scietific, regulatory, ad busiess eeds with advaced method developmet strategies ad techologies developed by S-Matrix ad prove by major pharmaceutical ad biotechology customers* Delivers a closed-loop solutio usig Quality-by-Desig priciples for a best practices approach to LC method developmet Reduces the time required for LC method developmet from weeks or moths to days Icreases laboratory productivity while reducig LC system solvet cosumptio ad associated disposal costs Cotrols ad records user access ad privileges with the itegrated Workflow Maagemet System *Krull, I.; Swartz, M.; Turpi, J.; Lukulay, P.H.; Verseput, R. A Quality-by-Desig Methodology for Rapid LC Method Developmet, Part III, LCGC [Olie] 2009, 27 (4),

8 S-Matrix Products ad Support S-Matrix Corporatio develops advaced Desig of Experimets based-software that automates R&D experimetal work accordig to Quality-by-Desig priciples ad methodologies. For the Pharmaceutical ad Biotechology idustries, S-Matrix s Fusio AE platform automates ad redefies experimetatio i Aalytical R&D, Chemical ad Process R&D, Formulatio, ad Product R&D. Fusio AE Automated Experimetatio Software Suite Fusio LC Method Developmet Rapidly develop ad optimize robust LC methods o istrumets from multiple vedors. Fusio LC Method Validatio Meet regulatory guidelies with a best-practices approach toward LC method validatio with comprehesive reportig. Fusio Ihaler Testig Collate ad calculate results, ad geerate reports accordig to USP 601 ad Ph.Eur Fusio Product Developmet Combie advaced Data Miig with completely customizable, state-of-the-art Desig of Experimets capabilities. Dissolutio Method Developmet Create testig desigs ad ru method developmet experimets o dissolutio apparatus from multiple vedors. Fusio Tabletig R&D Desig ad ru experimets for tablet presses ad coaters i a closed loop with dissolutio testig apparatus ad associated LC. Fusio Sythesis Optimize the sythesis of compouds i chemical reactors while miimizig impurities ad side reactio products. Sales ad Techical Support Sales: or Techical: or , Weekdays 8AM-5PM, Pacific Time sales@smatrix.com ad support@smatrix.com FAX: Workshops ad Traiig S-Matrix offers a wide rage of workshops as well as traiig programs for istalled systems. Iteractive workshops review curret techologies, geeral pricipals of DOE ad QbD, as well as S-Matrix products. Workshop listigs ca be foud o Hads-o traiig programs are tailored to suit your experimetal requiremets. Traiig icludes experimet strategies, desig of experimets, data aalysis, graphical visualizatio, ad product ad process optimizatio. To arrage a customized workshop or traiig program at your locatio for five to te participats, call All trademarks are the property of their respective owers LCGC.r1 4/10 Prited i U.S.A. S-Matrix S-Matrix Corporatio 1594 Myrtle Aveue Eureka, CA USA