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Philip Bassignani Lab Director, Applications Laboratory Fluid Management Systems

Automated High Throughput Sample Prep as a tool to speed up the accreditation process and ensure compliance for POPs analysis. Philip Bassignani Lab Director, Applications Laboratory Fluid Management Systems. FMS,Inc. Own and operate in >150,000 sq ft facilities

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Philip Bassignani Lab Director, Applications Laboratory Fluid Management Systems

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  1. Automated High Throughput Sample Prep as a tool to speed up the accreditation process and ensure compliance for POPs analysis Philip Bassignani Lab Director, Applications Laboratory Fluid Management Systems

  2. FMS,Inc. • Own and operate in >150,000 sq ft facilities • Manufacture all products in the USA • Focus is Automating Sample Preparation processes • Applications Lab in Watertown, MA • Sales and Service Worldwide • Manufacturer reps Domestic and International • Applications Specialists • Service Engineers

  3. Our Business • Markets served • Agricultural • Chemical Products • Clinical • Environmental • Food and Beverage • Pharmaceutical Products • Natural Products • Petrochemical

  4. Why implement Automated Sample Prep in the Accreditation process? • Fastest possible turn around time of results • Control the cost of analysis • Cut the cost of the analysis • Improve the quality of data

  5. Common POPs for analysis • Pesticides • PCBs • Dioxins • PBDEs • Packaging contaminants • Pharmaceutical and Personal by products • Environmental Contaminants

  6. Sample Prep Sample Extraction Sample Cleanup Sample Concentration

  7. Pressurized Liquid Extraction for solid samples

  8. Solid Phase Extraction for liquid samples

  9. Automated Sample Cleanup

  10. Direct to Vial Concentration

  11. The Total Prep Automates Sample Prep Steps

  12. What is ISO 17025? • Global ISO Standard • Defines requirements for a quality system in Laboratories • Testing laboratories • Calibration laboratories • Developed from ISO Guide 25 • First ISO 17025 edition in 1999 • Second edition in 2005 • Today’s focus: Testing Laboratories

  13. Who Needs ISO 17025 Accreditation? • Service Laboratories • Food Testing • Environmental Testing • Chemical Laboratories • Clinical Diagnostics Laboratories • Whenever a Laboratory Requires a Laboratory Quality System

  14. Benefits of ISO 17025 Quality System • Allows the lab to get contracts from industry and governments • More customers • National and International recognition of laboratory work • More customers • Higher degree of customer loyalty • Streamline lab operations through standardized processes and procedures • Higher efficiency • Long term return of investment

  15. What makes up ISO 17025? • Scope • Normative references • Definitions • Management Requirements (15 Sub-chapters) • Technical Requirements (10 Sub-chapters) • Appendix A: Nominal cross-references to ISO 9001:2000 • Appendix B: Guidelines for establishing applications for specific fields • Bibliography

  16. ISO 17025 Management Requirements • Organization and responsibilities • Management system • Documentation control • Review of request, tender, or contract • Subcontracting of tests or calibration • Purchasing of services and supplies • Service to the customer • Complaints • Control of nonconforming testing • Improvement • Corrective action • Preventative action • Control of records • Internal audits • Management reviews

  17. ISO 17025 Technical Requirements • General • Personnel • Accommodation of environmental condition • Test and calibration methods and method validation • Equipment • Measurement traceability • Sampling • Handling of test and calibration items • Assuring the quality of test and calibration results • Reporting the results

  18. Automated Sample Prep implemented in Technical Requirements • An FMS Automated Sample Prep workflow test case for speeding up the accreditation process • Focus on speeding up the Technical Requirements timeline • FMS worked with a lab applying for ISO 17025 Accreditation • Toxic Report

  19. FMS Automated Sample Prep Test Case • Provide the client with IQ, OQ and PQ • Provide SOPs for all Automated Sample Preps • Replace Manual Sample Preps • Time consuming • Error prone • Labor intensive

  20. Toxic Report Automated Sample Prep Lab

  21. Toxic Report Automated Sample Prep Lab

  22. Toxic Report Analytical Lab

  23. Turn Around Time Manual Versus Automated Sample Preps

  24. Manual Versus Automated Sample Preps • Labor costs and resources are lessened • SPE extraction • Manual Labor 60 minutes • Automated Labor 10 minutes • Solids Extraction • Soxhlet Labor 40 minutes • Pressurized Liquid Extraction 15 minutes

  25. ISO 17025 Accreditation for 16 groups and matrices • Labs going for accreditation using Manual Sample Preps • Typically plan on an 18 to 24 month project • Many People • Test Case using Automated Sample • Completed the project in 9 months • 3 people

  26. Manual Versus Automated Sample Preps • Concentration • Manual Labor 45 minutes • SuperVap Labor 10 minutes • Sample Cleanup • Manual Labor 8 to 16 hours • PowerPrep Labor 15 minutes

  27. Total Turn around time for 16 groups and matrices • Automated Solid Sample Preps • 34 days • Manual Solid Sample Preps • 96 days • Automated Liquid Preps • 26 days • Manual Liquid Preps • 29 days

  28. Implementing Automated Sample Prep in your accreditation scheme • Makes it easier and faster to get the Accreditation process completed • Provides consistent reproducible results • Eliminates rerunning sample preps • Eliminates error due to Human interaction • Less SOPs to generate and maintain • Reduces labor costs • Reduces operating costs

  29. Questions?

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