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Power of CFD simulation in pharmaceutical mixing applications

  1. © 2011 ANSYS, Inc. April 27, 20171 Overview of ANSYS simulation software for pharmaceutical mixing applications
  2. © 2011 ANSYS, Inc. April 27, 20172 LEAP Australia Overview • ANSYS Partner in Australia since 1996 • 45+ permanent staff and growing • Sales and Support for Best in Class Engineering Software • Engineering Consultancy Services • Training & Mentoring
  3. © 2011 ANSYS, Inc. April 27, 20173 *Busines ANSYS is the Worldwide Simulation Leader FOCUSED This is all we do. Leading product technologies in all physics areas Largest development team focused on simulation CAPABLE 2,700+ 75 40 employees locations countries TRUSTED FORTUNE 500 Industrials 96 of the top 100 ISO 9001 and NQA-1 certified PROVEN Recognized as one of the world’s MOST INNOVATIVE AND FASTEST-GROWING COMPANIES* INDEPENDENT Long-term financial stability CAD agnostic LARGEST 3x The size of our nearest competitor
  4. © 2011 ANSYS, Inc. April 27, 20174 Top Healthcare and Pharmaceutical Companies Rely on ANSYS software Medtronic Boston Scientific St Jude CR Bard Thoratec Quest Medical Edwards Cortronik Nikkiso Berlin Heart Philips Healthcare Synthes Joghnson & Johnson (Depuy) Medtronic Zimmer Stryker Biomet Mayo Clinic Orthofix BIEN-AIR Dental United GE Healthcare Siemens Healthcare Philips Healthcare Hitachi Medical Toshiba Medical Samsung Olympus IBA FluidDA Baxter Becton Dickinson Beckman Coulter Carl Zeiss Covidien Drager Medical Fresenius Resmed Starkey Labs. Thermo Fisher GN Resound Roche Pfizer Merck Novartis AstraZeneca GSK Ely Lilly Takeda Pharmaceutical Abbot Alcon Labs Johnson & Johnson Sanofi Aventis Boehringer Ingelheim
  5. © 2011 ANSYS, Inc. April 27, 20175 ANSYS Partners with Thought Leaders, Influencers and Decision Makers Regulatory Authority Interaction Industry Consortia Participation Academic Thought Leader Collaboration
  6. © 2011 ANSYS, Inc. April 27, 20176 Pharmaceutical industry leaders have adopted engineering simulation to meet their key performance indicators The mass transfer uniformity of a 15,000 liter mammalian cell culture bioreactor with modified pitched blade impellers was demonstrated by a computational fluid dynamics (CFD) model using ANSYS Fluent1. We have successfully demonstrated that scale-up of solid dissolution can be achieved using a systematic process of lab-scale experiments followed by simple CFD modeling [ANSYS Fluent] to predict commercial- scale experimental conditions. In particular this method is sought to identify major dissolution issues at lab scale before the large expenses of processing and raw materials (particularly API) are committed. […] This approach paves a way to utilize modeling in scaling up liquid mixing processes towards the direction of quality by design2. An accurate prediction of Oxygen Transfer (OT) requires the use of multiphase models. The Mixture multiphase model in FLUENT is ideally positioned to enable prediction of OT. The Mixture multiphase model can be used to predict hydrodynamic conditions of both gas and liquid phases. It can also track Oxygen transfer from a gas phase to a liquid phase. With suitable kinetic models for OT, it is possible to model the local Oxygen transfer from the gas phase to the mammalian cells3. "Boehringer Ingelheim is taking advantage of CFD analysis to gain more process understanding during development of new drugs." Testimonials 1: Mixing Uniformity Characterization of 15K Mammalian Cell Culture Bioreactor., Schmidt, B., ASTRA ZENECA Hodson, D., Astra Zeneca Boyds, A., Astra Zeneca Reynolds, G., Astra Zeneca, 2010 AIChE Annual Meeting 2: “Application of Modeling to Scale-up Dissolution in Pharmaceutical Manufacturing” Venkat Koganti,1,4 Fred Carroll,1 Richard Ferraina,1 Rick Falk,2 Yogesh Waghmare,2 Mark Berry,1 Yang Liu,1 Kenneth Norris,1 Robert Leasure,3 and Jeffrey Gaudio3, October 2010 3: “Predicting Dissolved Oxygen Concentrations in Bioreactors”, Gary Finka, GSK, Mammalian Process Research
  7. © 2011 ANSYS, Inc. April 27, 20177 Effective Medical Innovation Ensuring Extreme Product Reliability Personalized (P4)* Medicine Affordable and Profitable Medicine Compress Time to Market To Meet these Global Trends We See Investment in a Number of Key Business Initiatives (KBIs) * Personalized, Participatory, Predictive, Preventiv
  8. © 2011 ANSYS, Inc. April 27, 20178 Solution for Pharmaceutical Process Mixing scale up: 20 liter 20000 liter Drug Delivery Packaging Crystallization Spray Drying Tablet compaction Patch Powder coating Chromatography Column Bioreactor – Cell Growth
  9. © 2011 ANSYS, Inc. April 27, 20179 Drug Manufacture Mixing Scale up Gas sparging Mass transfer Reacting flows Crystallization Mechanical stability Solid suspension Shaft vibration Picture Velocity vectors (left) and gas distribution (right) calculated in a tall Short circuiting at baffles Distribution of product molecular weight in an LDPE reactor Macro mixing structures, colored by vorticity contours, in a mixing tank with a 6-bladed Rushton impeller
  10. © 2014 ANSYS, Inc. April 27, 201710 ANSYS Confidential • Cost & Time: More cost effective and faster than multiple physical prototypes & experiments • Engineering Insight: Comprehensive prediction of mass transfer, pressures, velocities, concentrations allow you to quantify impact of scale-up & design changes, as well as looking inside the product to see what is going on • Rapid feedback to product development/clients: quickly answer “what if?” scenarios or perform more detailed optimisation Core benefits of using Virtual Prototypes
  11. © 2014 ANSYS, Inc. April 27, 201711 ANSYS Confidential What is CFD? Physics-based fluid flow simulation, or Computational Fluid Dynamics (CFD)  the science of predicting fluid flow, heat transfer, mass transfer, chemical reactions, and related phenomena by solving mathematical equations in 3D. The result is detailed information about all flow variables in the system, for example: • Flow patterns • Species concentrations • Turbulence levels • Local rates of mixing Geometry and Meshing
  12. © 2014 ANSYS, Inc. April 27, 201712 ANSYS Confidential CFD in the Pharmaceutical and Biopharmaceutical Industries ANSYS provides the broadest range of CAE solutions for:  Drug Manufacture  Separation Processes  Materials Handling  Drug Delivery  Packaging and Distribution
  13. © 2014 ANSYS, Inc. April 27, 201713 ANSYS Confidential Pharmaceutical industry - agitated vessels ANSYS has developed dedicated models for all aspects of pharmaceutical engineering. Recent examples include:  Fully-integrated simulation environment providing the broadest set of engineering simulation tools.  Numerous academic and industrial partnerships on pioneering projects.  Participation in major research projects.  A dedicated global team with focus on pharmaceutical technologies. 21 of the top 35 biotechnology and pharmaceutical companies use ANSYS tools Characterizing meso-mixing.
  14. © 2014 ANSYS, Inc. April 27, 201714 ANSYS Confidential Simulation results – flow and blend time Types of simulations done  Flow  Blend Time  Exposure Analysis (TDR, Shear Rate)  Zonal Residence Time Distribution (RTD) 20- Lite r 200-Liter 2000-Liter 20000-Liter 20-Liter 20L 200L 2000L 20000L Blend Time 25.8s 41.9 61.2s 111.8s 20L 200L 2000L 20000L RPM 63 37.7 22.6 13.6 CFD Upper Po 0.85 0.84 0.83 0.82 CFD Lower Po 0.5 0.49 0.48 0.48 Power Numbers: Blend Time Observations: • Vendor specified “single impeller” power number is 0.75 – Upper impeller close to that – Lower impeller draws lower power • Blend time increases with scale Power Number for both impellers Blend time for different sizes Time taken for the study ~ 1.5 days
  15. © 2014 ANSYS, Inc. April 27, 201715 ANSYS Confidential Simulation results – exposure analysis and zonal RTD Zone1 Zone1 Zone2 Zone3 Low intensity at high reactor volumes Dissipation Rate Exposure Analysis – Almost Identical environmentZonal Residence Time Distribution – Similar distribution at different scales Observations: Cells/Particles exposure to high shear rate decreases with increase in reactor size Dissipation rate profiles are identical “Normalized” Zonal Residence Time behaviors similar for all reactor sizes At different scale particles/cells will experience similar environment Time taken for the CFD study ~ 1.5 days Exposure Analysis: Shear Rate Exposure Analysis: Dissipation Rate Zonal Residence Time Distribution: Zone 1
  16. © 2014 ANSYS, Inc. April 27, 201716 ANSYS Confidential LEAP Australia contact details Kuthur Sriram M.Sc., MBA. Engineering Solutions Manager Suite 6, 750 Blackburn Rd, Clayton Nth 3168 phone: + 61 3 8542 7880 mobile: + 61 429 155 778 fax: + 61 3 8542 7899 email: Website: CFD Blog: