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. Getting 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).
Text of Getting It “Right First Time” Seminar Series – Part 2
1 The world leader in serving science Darren Barrington-Light Product Specialist, Chromatography Software, Thermo Fisher Scientific April 1, 2014 Getting It Right First Time Seminar Series Part 2 Part #: PP71261-EN0414S
2 Agenda Introduction How to get it right the first time? Thermo Scientific Dionex Chromeleon Chromatography Data System (CDS) tools for RFT analysis Standard Operating Procedures eWorkflows What they are, how they help and how you use them Example: Chromeleon Extension Pack - Dissolution Templates Summary
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 How to Get It Right the First Time?
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 Chromeleon CDS Tools for RFT Analysis
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 Standard Operating Procedures
9 Standard Operating Procedures What is a Standard Operating Procedure (SOP)? The International Conference on Harmonisation (ICH) defines SOPs as detailed, written instructions to achieve uniformity of the performance of a specific function or A document describing all steps and activities of a procedure that can be followed to attain a specific outcome
10 Standard Operating Procedures Sample check-in Sample preparation Instrument preparation Eluent preparation Sample analysis conditions Data analysis conditions Data reporting requirements Regulatory requirements Validation requirements Customer report requirements
11 Standard Operating Procedures So how do we help the analyst?
12 Standard Operating Procedures In laboratories, SOPs are used: To ensure an analysis is always performed the same way no matter who performs it To provide a step-by-step guide to analysts To ensure compliance To guarantee a specific outcome for an analysis
13 Lets Look at an Example
14 Dissolution Testing Used for immediate release dosage forms to: Assess the lot-to-lot quality of a drug product Guide development of new formulations Ensure continuing product quality and performance All pharmacopeias provide details on how to perform dissolution experiments United States Pharmacopeia 28, Chapter 711, Dissolution Test, 2005. European Pharmacopoeia 6.1, Chapter 2.9.3 Dissolution Test for Solid Dosage Forms, 2008. Japanese Pharmacopoeia 15th Edition, 6.10 Dissolution Test, 2007. British Pharmacopoeia 2014, Volume 5, Appendix 336, Dissolution, 2014 Cover procedures/apparatus for running experiments and for assessing the data
15 Dissolution Testing Dissolution experiments can use one of 7 methods: Method used depends on dosage form Paddle apparatus is most common for solid dosage forms Analyze a minimum of 6 separate dosage units
16 Dissolution Testing At the end of the time period, withdraw an aliquot of the fluid and perform the analysis using a suitable assay method. Suitable assay method: Sample analysis Instrumental conditions Injection requirements Data analysis Processing requirements Reporting requirements
17 Dissolution Testing Sample Analysis Example instrument conditions: Column temperature: 30 C Mobile phase: Solvent A (acetonitrile) and solvent B (water) 50:50 Flow rate: 1.0 mL/min Injection volume: 10 L Detection wavelength: 254 nm Running time: 20 min All controlled by the Instrument Method
18 Dissolution Testing Sample Analysis Example injection requirements: Assay 6 or 12 units individually A set of 6 check standard preparations should be analyzed to ensure system suitability Make single injections of all of the standard preparations Make single injections of sample preparations To monitor method variance, a control sample of known composition should be assayed at the end of each batch All controlled by the sequence structure
19 Dissolution Testing Data Analysis Example processing requirements: Accurately identify and integrate each component Prepare a linearity curve for the standards with the origin ignored, using peak area vs. concentration (mg/mL). The r2 must be 0.999 for each calibration curve. The Tailing Factor, Theoretical Plates, and %RSD should be calculated for the main analyte in the SST samples Controlled by the Processing Method
20 Dissolution Testing Data Analysis Reporting requirements (solid dosage forms): Average of the 12 (S1+S2) units is Q and no unit is less than Q 15%
21 Dissolution Testing Data Analysis Example other reporting requirements: The standard correlation should be calculated for the first and last standard of the sequence Chart the results of the control samples for each batch Typically, due to complexity of calculations, results are manually transcribed to external spreadsheets Introduces errors Time consuming reviews needed In the Chromeleon CDS software controlled by the Report Template
22 Dissolution Testing Most components of analysis are already in the CDS Many areas where manual sequence creation causes errors How do you ensure that your sequence is created and structured correctly? How do you know you have the right methods and report? How can you simplify analysis setup and execution? eWorkflows for fast, easy, accurate sequence creation
24 eWorkflows Definition An electronic procedure for automating laboratory processes related to a chromatographic analysis Assists user in creating an appropriate sequence for a suitable instrument with pre-defined associated files and a well-defined structure Guides you from samples to reliable results in the minimum number of steps
25 eWorkflows Contents Instruments on which the analysis can be run All associated files: Instrument methods Processing methods Reports Spectral libraries External documents (e.g. the SOP!) Template for sequence name and storage location Custom variables Signature requirements Rules for sequence layout Ensures consistency of analysis
26 eWorkflows eWorkflows can ensure your SOP is followed Reduces errors and produces reliable results faster Fully customizable for any application in any laboratory QA/QC laboratories Method development laboratories Research & Development laboratories Walk-up instrument workflows Minimizes amount of training required
27 How Do You Use eWorkflows?
28 eWorkflows Category Category bars in the Chromeleon Console Provide immediate access to all your instruments, data and eWorkflows
29 eWorkflows Category List of available eWorkflows eWorkflow description & status Available instruments & status
30 eWorkflows Ease of Use 1. Select eWorkflow 2. Select Instrument 3. Click Launch