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West Pharmaceutical Services Reusable Injectable Drug Delivery

West Pharmaceutical Services Reusable Injectable Drug Delivery. Team West Pharmaceutical Services Sponsors: Reginald Motley and Chris Evans Advisor: Dr. Singh BMEG: Ryan O ’ Boyle, Madison DeFrank , and Derek Hunter MEEG: Hayley Shaw and Kailey Nelson. BMEG450/MEEG401. 12/11/13.

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West Pharmaceutical Services Reusable Injectable Drug Delivery

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  1. West Pharmaceutical Services ReusableInjectable Drug Delivery Team West Pharmaceutical Services Sponsors: Reginald Motley and Chris Evans Advisor: Dr. Singh BMEG: Ryan O’Boyle, Madison DeFrank, and Derek Hunter MEEG: Hayley Shaw and Kailey Nelson BMEG450/MEEG401 12/11/13

  2. Background Pharmaceutical Packaging Systems Pharmaceutical Delivery Systems • 2012 Revenue: $915million • Market Leader • Global Manufacturing • Innovative and Proven Product Portfolio • 2012 Revenue: $352 million • Proprietary Devices/Delivery System Technologies • Collaborative Development • Contract Manufacturing Development Primary Package Administration Patient 12/11/13

  3. Motivation West hopes to expand their product line to include a range of products that are reusable. This would reduce wastes and overall costs Scope To research and develop a novel drive mechanism that can be reset and move a piston in a 1 mL syringe for dispensing of liquid 12/11/13

  4. Product Line SelfDose Confidose SmartDose • Disposable • Spring, motor, manually driven • Easy to use • At home use • Not on market yet 12/11/13

  5. Benchmarking Competing Products • Unilife LISA Auto-injector System • BD Pen II Reusable Pen • Cambridge Consultants Flexi-Ject Auto-injector 12/11/13

  6. Design Requirements 12/11/13

  7. Concept Generation • Round 1 • Shape Memory Alloy • Soft Metal Alloy • Flat Coil Spring • Motor Driven • Hydraulic Component • Round 2 • Neodymium Magnets • Chemical Reaction • Coil Wire/ Electromagnetic Force FINAL CONCEPT: Shape Memory Alloy • Top 2 Concepts • Shape Memory Alloy • Neodymium Magnets 12/11/13

  8. ShapeMemoryAlloy • Deformable alloy material • Returns to original shape when heated • Nitinol = nickel + titanium • Transition temperature is 70-80oC • Nitinol springs used as driving force 12/11/13

  9. Nitinol Spring Video 12/11/13

  10. Preliminary Testing • 1 Spring tested • Two different vendors • Spring displacement held constant Spring 1: Spring 2: Conclusion: Spring 2 provides a more cost effective solution. 12/11/13

  11. Final Prototype Drive Mechanism Battery Pack Syringe Toggle Switch 12/11/13

  12. Design Overview Inner Assembly Top Platform • Lined with heat shielding tape • Fiberglass tape shields 260oC • Foil tape reflects 815oC • 8 stretchable Nitinol springs • 11.1 V battery pack • 3.5 A through each spring • High-amp toggle switch Plunger Rod Nitinol Springs Bottom Platform Syringe 12/11/13

  13. Design Overview Outer Assembly Top Casing • Prefilled syringe inserted through bottom platform • Locking platform secures syringe • Springs supply up to 16.9 lb force • Can be reset to prepare for new injection • New syringe inserted after injection Inner Assembly External Casing Syringe Locking Platform 12/11/13

  14. Validation Testing Observational Testing 12/11/13

  15. Validation Testing Experimental Testing 12/11/13

  16. Cost Analysis Purchased Parts Prototype Cost (per unit) 46.6% of Budget Spent 12/11/13

  17. Path Forward • Optimize force generated: use Nitinol springs of different composition • Use ultra-capacitors in order to eliminate the need for a large battery • Coating in heat shielding material during manufacturing stages • Downsizing the system to maximize compactness • Incorporate automatic shut off system • Increase safety • Decrease spring fatigue. 12/11/13

  18. Thank you! Questions? 12/11/13

  19. Delrin • Polyoxymethylene (Acetel) Resin • Melting point = 175oC • Can be injection molded Manufacturing CostPer Unit (1000 units made) 56.1% Decrease! 12/11/13

  20. Stress Analysis Applied Force: 10 lbs Applied Force: 18 lbs

  21. Viscosity Testing

  22. Failure Testing A trial was deemed a failure if a full dose of liquid was not dispensed or heat of the springs produced visible smoke.

  23. Magnet Concept • Magnets were very difficult to work with • Preliminary testing showed that concept was unable to displace plunger of an empty syringe

  24. Magnet Testing 1

  25. Magnet Testing 2

  26. Concept Generation Round 1 • Shape Memory Alloy • Soft Metal Alloy • Motor Driven • Flat Coil Spring • Hydraulic Component

  27. Concept Selection Round 1 Winning Concept = Shape Memory Alloy!

  28. Concept Generation Round 2 • Chemical Reactions • Potassium Chlorate + Sugar • Magnet Gun • Solenoid Coil Gun

  29. Concept Selection Round 2 Winning Concept = Magnet Concept!

  30. Current Optimization

  31. Working Prototype

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