Lonza Moda Solution Overview 2010 Final 18 Aug2010

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Lonza Moda Solution Overview 2010 Final 18 Aug2010

  1. 1. MODA™ Solution Overview x Rapid Testing Solutions / Lonza / 10 August 2010
  2. 2. Agenda <ul><li>Introductions </li></ul><ul><li>Lonza Rapid Testing Solutions </li></ul><ul><li>MODA™ Solution Highlights </li></ul><ul><li>Comparison of QC Micro Processes </li></ul><ul><li>Demonstration </li></ul><ul><li>Questions & Answers </li></ul>
  3. 3. Lonza’s Life-Science Platform Custom Manufacturing Nutrition Ingredients Microbial Control Performance Intermediates Therapeutic Cell Solutions Rapid Testing Solutions Research Solutions Chemical Manufacturing Biological Manufacturing Development Services Life Science Ingredients Bioscience MODA™ Solution Endotoxin Detection Microbiology Informatics Solutions Support
  4. 4. Rapid Testing Solutions <ul><li>Endotoxin Detection - LAL-based assays, sustainable recombinant Factor C technology, plate readers and robotic liquid handling systems </li></ul><ul><li>Microbiology - Includes the microCompass™ system, a qPCR-based method that detects bacteria, yeast and mold in less than six hours with applications for sterility and bioburden testing </li></ul><ul><li>Informatics - Integrated and flexible software solutions, including the WinKQCL ® system and now the MODA ™ solution providing results on demand, helping customers make intelligent decisions </li></ul><ul><li>Solutions Support - Service programs, equipment and software validation, LIMS support, instrument training and lab testing services </li></ul>
  5. 5. Value Proposition <ul><li>More science. Less paper. </li></ul><ul><ul><li>Increase operational efficiency, improve quality, reduce costs </li></ul></ul><ul><ul><li>Quickly move from paper-intensive QC monitoring/analysis </li></ul></ul><ul><ul><li>Gain measurable ROI and significantly enhance compliance </li></ul></ul>
  6. 6. The Solution Improved Compliance Increased Productivity Expedited Decision Making Paperless, Automated Laboratory MODA ™ Solution Components Mobile Data Acquisition Flexible Workflow Integration On-Demand Analytics Systems (ERP, LIMS, CAPA) Devices Media
  7. 7. MODA™ Solution: Features <ul><li>Comprehensive quality control platform: </li></ul>Feature Description Complete Workflow Automates sampling, testing, incubation, and results-entry functions for EM, Utilities and Products; guiding the user and preventing process deviations. Mobile & Flexible Utilizes specialized hardware, RFID, and barcoding technology to automate data capture at the sampling site. Entirely Paperless Eliminates all paper schedules, hand-written notes, reconciliation, and transcription activities. On-Demand Analysis Provides on-demand reporting, tracking, trending, and visualization of critical information without exporting and reformatting data.
  8. 8. MODA™ Solution: Benefits <ul><li>Tangible, measurable benefits: </li></ul>Feature Description Cost Reduction Significantly less personnel hours on data entry, paperwork, and other clerical functions. Productivity Improvements Collect and process more samples with the same or fewer personnel. Refocus personnel on value-added activities. Enhanced Compliance Reduced errors and process deviations; faster turnaround of information for CAPA activities and product release. Return on Investment Solution investment: typically returns positive cash flow in 6-36 mos. LIMS investments: significantly enhanced with a COTS QC solution.
  9. 9. “ Go Green” with MODA™ Solution
  10. 10. MODA™ Solution: Components MODA-EM™ Client Software to manage the entire lifecycle of EM samples without paper MODA-FDC™ Mobile Field Data Capture platform for sampling in all critical areas MODA-EM™ Server Database to store, administer, and report all EM data MODA-VIP™ Visual Intelligence Portal, advanced visualization of EM data
  11. 11. MODA-FDC™ Cart <ul><li>Featured: MODA-FDC™ platform, used for field data capture in clean room areas </li></ul><ul><li>Stainless steel cart </li></ul><ul><li>Ergonomic tablet PC </li></ul><ul><li>Docking station </li></ul><ul><li>Thermal label printer </li></ul><ul><li>Barcode scanner gun </li></ul><ul><li>Proximity reader for RF badges </li></ul><ul><li>Space for equipment </li></ul><ul><li>Space for growth media </li></ul>
  12. 12. Comparison: QC Micro Processes (MODA™ Solution) Rapid Testing Solutions / Lonza
  13. 13. The Paper-based QC Process Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
  14. 14. The Paperless QC Process— 11 Steps Removed Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
  15. 15. Paperless Efficiency Example Paper 8 hours – Paperless 4 Hours = Savings 4 Hours
  16. 16. The Paper-based QC Process Example: Non-Viable Air Testing
  17. 17. The Paperless Process Example: Non-Viable Air Testing
  18. 18. Automated Reporting and Analytics
  19. 19. Demonstration (MODA™ Solution) Rapid Testing Solutions / Lonza

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