1. ILC Dover Film Welding System James Harmon Tommy Lupinski Katherine Nitz Dan Vennard

2. ILC Dover Background  ILC offers containment solutions for processing active pharmaceutical products  Effective and safe systems get products to market faster  Containment products include  DoverPac ®  Continuous Liner  DoverPac ® SF Pharm / Biopharm Products

3. Current Sealing Techniques  Twist-tie-tape and cut  Crimping  Thermal welding  Senior Design focus

4. Current Thermal Welder $100,000

5. Why the high cost?  Film welder needs to be “explosion-proof” due to its surroundings  Design must meet several requirements for approval  Electrical requirements are main hurdle  Regulatory agencies involved  NFPA  Class 1, Class 2, Division 1  Articles 496, 497  ATEX  Ensuring the machine is explosion-proof is very expensive!

6. Project Objective  To design a film welder that can successfully seal plastic layers together in an explosive environment without using electricity  Eliminate electrical system approval hurdles  Reduce cost  Produce an engineering model of the film welder  Model must meet all performance specifications possible  Concentration on non-electrical aspect Project Scope

7. Customer Specifications Sealing temperature goal130°C (266°F) Sealing pressure goal20psi ± 5psi Cost per use$3 Exterior temperature50°C (120°F) Operators required1 Full sealing cycle time2 minutes* Sealing area 37” x 1.5” (23” Ø bag) Metric Target Value Be safe for the user Meet NFPA and ATEX regulations Use no electricity! Constraints *This target value was increased to around 5 minutes.

8. 3-D Concept Design Heating arm Pressure arm

9. Steps to Complete Cycle Start Flush with H 2 O Remove sealed plastic Add chemicals Insert plastic Apply pressure

10. Concept Subsystems Heating & Cooling System Pressure System Heat Generation System Thermal Sealer Prototype

11. Heat Generation System The system requires…  Ability to reach temperature of 130°C as quickly as possible  Safe chemical components Concepts Heat Generation Concepts Epoxy Resin Hydrogen Peroxide (H 2 O 2 ) Decomposition

12. H 2 O 2 Decomposition Testing Mixed H 2 O 2 and MnO 2 in…  An open beaker  Maximum temperature was 90°C  A pressurized copper pipe  Maximum temperature was 144°C  Temperature goal cannot be reached if not pressurized  Amount of MnO 2 only affects speed of reaction, not the temperature the mixture can reach Lessons Learned…

13. Heating & Cooling System The system requires…  Efficient heat transfer (for heating and cooling)  Insulation to ensure cool outer surface  User-friendly chemical addition system  Effective drainage Heating & Cooling Concepts Hollow Al chamber  Eliminated copper tube “middle man”  Increased heat transfer efficiency

14. Heating & Cooling System Analysis  Internal pressure analysis  Need pressure valve that releases between 150psi and 200psi  Force analysis  Found deflection of steel casing  Adjusted thickness to minimize it

15. Aluminum end-cap (green) Aluminum channel (grey) H 2 O 2 / H 2 0 input valve Pressure relief valve MnO 2 input valve Draining valve (on bottom) Progressive Assembly Step 1 Step 1 Air valve

16. Silicone rubber insulation (blue) Bungs for welding (red) Step 2

17. Step 3 Steel casing (grey) Locking bar (teal) Steel end-cap (turquoise)

18. Fully Assembled View

19. Pressure System The system requires…  Even pressure application along length  Ability to impose a tear strip on plastic  Withstanding pressure from inflated bladder Pressure Concepts Inflatable bladder Lever & lock Turn screw

20. Pressure System Analysis  Force analysis  Found deflection of steel backing  Adjusted thickness to minimize it  Found force on the locking pin  Determined the required diameter needed

21. Pressure Assembly Step 1 Interior guide blocks (red) Steel backing (turquoise) Steel casing (blue)

22. Step 2 Pressure plate (green) Exterior guide blocks (red) Force pad (blue) Tear strip O-ring (pink) Pressure bladder (grey)

23. Fully Assembled View

24. Comprehensive Concept Design Put in REAL picture of it assembled!!!!!

25. START Steps to Add Chemicals Open MnO 2 valve Add 1g of MnO 2 Open H 2 O 2 valve Add 250mL of H 2 O 2 Close MnO 2 valve Close H 2 O 2 valve

26. Film Welder in Action  Setup  Pressurize  Add chemicals  Flush system with water  Depressurize  Remove sealed plastic

27.  Heating & cooling system  Validate:  Time to seal  Sealing temperature goal  Sealing area  Exterior temperature  Pressure system  Validate:  Sealing pressure goal  Even pressure distribution  Test entire prototype  Validate:  One operator required  Cost per use System Validation

28. Heating Arm Testing  Heating Arm Testing  Isolated heating arm  Varied chemical amounts  150-250mL H2O2  0.5-1.0g MnO2  Varied chamber pressure  60-200psi  Varied MnO 2 input valve location Trial 1-6: 150mL H 2 O 2, 0.5g MnO 2 Trial 7-15: 250mL H 2 O 2, 1g MnO 2

29. Results and Validation  Results  Temperature peak is very inconsistent  Target value for temperature was not met but plastic did seal  Average time to seal was 2 minutes, 24 seconds  Validation –Time to seal  2 minutes, 24 seconds –Sealing temperature goal  127°C –Sealing area  14” x 1.5” –Exterior temperature  25°C

30. Pressure Arm Testing  Pressure Arm Testing  Isolated pressure arm  Inflated bladder with air pump  Used Pressurex® pressure sensing film Trial 1 Trial 2

31. Results and Validation  Results  Very even pressure distribution across length  Across o-ring, pressure was about 75psi  Elsewhere, pressure was less than 28psi  Tear strip was imposed  Validation –Sealing pressure goal  < 28psi –Even pressure distribution  Yes

32. Target vs. Actual Values Sealing temperature goal130°C (266°F)127°C (°F) Sealing pressure goal20psi ± 5psi< 28psi Cost per use$3≈ $4 Exterior temperature50°C (120°F)25°C (77°F) Operators required11 Full sealing cycle time5 minutes≈ 5 minutes Sealing area37” x 1.5”14” x 1.5” MetricTarget ValueActual Value

33. Budget ComponentCost Heating arm$393 Pressure arm$225 Testing$348 Total cost$966

34. Handoff to ILC  Sealing can be accomplished using non- electrical means  Hydrogen peroxide decomposition is one successful method  Purchase a more accurate pressure relief valve  Further work needs to be done in order to transfer product to industry  Patent potential after further investigation and testing

35. Acknowledgments Sponsor ILC Dover –Dave Cadogan and Anshu Dixita Advisor Dr. Keefe Technical Advisors Dr. Wingrave (Chemistry Department) Steve Beard (Machine Shop) Dave Styer (Machine Shop)

37. Heat transfer analysis –Found temperature of 133°C is required to ensure full heat conduction through plastic Thermodynamics –Found 180mL of H 2 O 2 is needed to get reaction to 133°C Heat Generation Analysis T 1 =133 ° C T 2 =130°C Input heat

38. Pressure System Budget Steel (backing, end-caps, arms)$190 Aluminum (U-channel)$33 Schraeder valve$2 O-ring$3 Force distribution pad$37 Total System Cost$265 *ILC has agreed to take care of making the inflatable bladder.

39. Heating/Cooling System Budget Aluminum (end-caps, chamber)$25 Steel (casing, locking bar)$55 Insulation$75 Plumbing (pipes, valves, hoses, etc.)$140 Total System Cost$295 *ILC has agreed to take care of all welding needs.