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Automating Fermentation

Automating Fermentation. Presenters. Todd Ham Automation Engineer Emerson Process Management, Life Sciences, Food, and Beverage Todd Edgington Automation Engineer Genentech NIMO Facility, Oceanside, CA. The NIMO Project Overview.

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Automating Fermentation

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  1. Automating Fermentation

  2. Presenters Todd Ham • Automation Engineer Emerson Process Management, Life Sciences, Food, and Beverage Todd Edgington • Automation Engineer Genentech NIMO Facility, Oceanside, CA

  3. The NIMO Project Overview • NIMO is a large scale, multi-product biopharmaceutical complex. • Fermentation/Recovery process • Fermentation • Centrifuges, Chromatography, UF/DF, … • CIP/SIP • Fully automated • Recipe-level batch control • Warehouse management • Electronic signatures • Electronic records

  4. The NIMO Project Timeline 2000 2002 2004 2006 2008 NIMO Engineering Kick-Off Engineering and Design Procurement Construction Commissioning Validation BLA Enabling Runs BLA Submission FDA Review BLA Approval

  5. NIMO Philosophy • Fully automated • Paperless, dock-to-dock • Electronic record • Handheld units for plant operations • Barcode scanning for material additions, filters • Consistency for operator / Use of industry standards • Bus technologies • S88 / S95 • Fermentation was integral to entire project • Project philosophy impacted fermentation • Fermentation impacted project philosophy

  6. The Fermentation Process Overview CIP/SIP Feed Vessel (for Large Fermenters) Pressure Control Inoculation Media Additive Sparge Sampling Base

  7. S88 Control Modules • Identify the “common” modules and instances. Examples: Motors Valves

  8. Used some project-wide module templates Sampling System Sparger Control Added some area-specific module templates Fermentation Agitator Control Fermentation Pressure Control Fermentation Temperature Control pH Control Dissolved Oxygen Control Foam Control Added unique (one-time use) equipment modules Transfer Panels Valve Assembly (VA) Control S88 Equipment Modules

  9. Transfer Panel

  10. S88 Units • Identify classes and instances based on.. • Physical similarity • Phases that they use • Batch Media • Inoculate • Ferment • Etc.

  11. Batch Feed Vessel Batch Fermenter Pre-inoculation Prep Inoculate Ferment Sample Add Additive Add Base Add Feed Media Transfer Pressure Test The following CIP Phases for Feed Vessel, Production Fermenter, Seed Fermenter, Discharge Line, and Media Line CIP Setup CIP Circuit CIP Complete Pre-SIP Pressure Test Seed Fermenter Pre-SIP Pressure Test Production Fermenter Pre-SIP Setup SIP Sample Line SIP Production Fermenter SIP Inoculation Line Phase Control

  12. Recipes • Group Phases into Operations • Group Operations into Unit Procedures • Group Unit Procedures into Procedures

  13. Vessel to Vessel Communication Are you ready to receive? Here comes the transfer. Yes. Bring it on. I got it.

  14. MAT 2. 200 GR Manufacturing Procedures • Material Management • Container Management • Filter Management • Sampling

  15. Testing • Emerson and Genentech worked together closely on requirements • Emerson performed module-level and integration–level testing • Emerson and Genentech ran a full Customer Acceptance Test (CAT) prior to delivery

  16. Lessons Learned – Modularity • As much as possible, keep process units the same. • With similar units, make sure operations are as uniform as possible as well! • Beware of alias over-load. • Enforcement of classes can be a negative thing.

  17. Lessons Learned – Level of Automation • High levels of automation are a double edged sword. • With high levels of automation and modularity, documents can become very numerous.

  18. Lessons Learned – Up-Front Testing • Time spent upfront saves on back end effort. • Easier to fix problems off-site when you are in control of the software. • Risk based software validation works. • No level of testing will capture all mistakes or prevent changes.

  19. Lessons Learned – Raw Material Handling and other Manufacturing Procedures • Make sure everyone is on the same page from the start. • Make sure everyone uses the same language. • Get operators time on the equipment.

  20. Conclusion • Leverage the S88 model as much as possible. • Take as much time as possible upfront. • Prepare for an effort commensurate with your level of automation. Right-Size

  21. Acknowledgements Genentech • Johannes Roebers • Christoph Lebl • Dave Stewart • Sean Stephan • Debi Marshall • Christopher Birnie • Leonidas Castaneda • Jim Merrit • Dirk Ellison • Emerson • Christie Deitz • Craig Bieda • Brian Crandall • Molly Firkins • Dick Seeman • Chen Yang • Shelley Richards • Ajay Savargaonkar • Ketaki Raste

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