Pit-Stop express, innovation in distribution, pharmaceutical cold chain. Phase Change Material.

1. Pharmaceutical & Bio Cold Chain Conference - 2011 Behind-The-Scene:Options for Bio Pharma Shipments by Capt. Pawanexh Kohli Founder, CrossTree techno-visors

3. Airport loading/handling prior to departure.

4. Air transport - Flight transfers.

5. Airport arrival delay pending release.

6. Ground transport for last leg delivery.

7. Storage option for out of hour arrivals.Passive Cooling with safety Margin and Qualified packaging to counter extreme Ambient Temperature variations in transit. Mumbai 90°F 32° Jaipur 111°F 44°C Current Scenario

8. The ChallengesAir mode Wide fluctuation in external ambient. Dynamic chain of custody. Transit time limited due to cold chain system. Routing limited via existing airports only. Contingency “Plan B” options limited. Volatility in air capacity and ATF.

9. Typical Surface Network Uses feeder service to consolidate. Long haul with transit times extension. Optimised routing via various touch points. Door step delivery through last mile feeders. Low cost option, mixed load option.

10. Surface ModeDistribution Network

11. Surface ModeDistribution Network Operating Unit

12. Surface ModeDistribution Network Pick-up Point Operating Unit

13. Surface ModeDistribution Network Pick-up Point Operating Unit

14. Surface ModeDistribution Network Pick-up Point Distribution Centre Operating Unit

15. Surface ModeDistribution Network Feeder System Pick-up Point Distribution Centre Operating Unit

16. Express Distribution Centre Pick-up Feeder Operating Unit Surface ModeDistribution Network

17. OR Express Distribution Centre OU Feeder Pick-up Feeder Operating Unit EDC Surface ModeDistribution Network

18. OR Express Distribution Centre Express Connection OU Feeder Pick-up Feeder Operating Unit EDC Surface ModeDistribution Network

19. OR Express Distribution Centre Express Connection OU Feeder Pick-up Feeder Operating Unit EDC Surface ModeDistribution Network

20. OR Express Distribution Centre Express Connection OU Feeder Pick-up Feeder Networked / Tracked Operating Unit EDC Surface ModeDistribution Network

21. OR Express Distribution Centre Express Connection OU Feeder Pick-up Feeder Networked / Tracked Operating Unit EDC Surface ModeDistribution Network

22. Spoke Origin - Destination HUB HUB Spoke Destination Origin Spoke Networked / Tracked HUB HUB Spoke Spoke Spoke Spoke Networked / Tracked Spoke Surface ModeDistribution Network

23. Advantage Surface Network Allows Inclusive logistics in future plant and distribution site planning Superior planning of service expansions Establish Quality Agreements between custodial stakeholders Limits potential for a logistics logjam and a storage nightmare.

24. Upping the Ante It’s not just about developing safe and effective vaccines.... It’s about getting vaccines to the right place, at the right time, in the right condition..... and...that means delivery systems that are as advanced & innovative as the vaccines they support.

25. ‘Pit-Stop’ ExpressRight Cost Solution

26. Pit-Stop Process Pickup Point Dispatch OU

27. Pit-Stop Process Pickup Point Dispatch OU Enroute Touch Point

28. Pit-Stop Process Pickup Point Dispatch OU Enroute Touch Point Waiting/Cooling

29. Pit-Stop Process Pickup Point Dispatch OU Enroute Touch Point Waiting/Cooling Re-Charge Needed?

30. Pit-Stop Process Pickup Point Dispatch OU Enroute Touch Point Waiting/Cooling Re-Charge Needed? YES

31. Pit-Stop Process Pickup Point Onward Transit Dispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? YES

32. Pit-Stop Process Pickup Point Onward Transit Dispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? YES

33. Pit-Stop Process Pickup Point Onward Transit Dispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? NO YES

34. Pit-Stop Process Pickup Point Onward Transit Dispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? Onward Transit Receiving OU Customer Out Reach Point NO YES

35. Pit-Stop Process Pickup Point Onward Transit Dispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? Onward Transit Receiving OU Pit-Stop Customer Out Reach Point NO YES

37. Shipper Outer SealDispatch OU Seal Shipper Enroute Touch Point Replace Chill Packs Waiting/Cooling Open Shipper Re-Charge Needed? Onward Transit Receiving OU Pit-Stop Customer Out Reach Point NO YES

40. Pit-stop ChecklistWaiting/Cooling Open Shipper Re-Charge Needed? Onward Transit Receiving OU Pit-Stop Customer Out Reach Point NO YES

44. Recharge Chill PacksDispatch Onward Transit Receiving OU Pit-Stop Customer Out Reach Point NO YES

45. Value added - Advantages Multi-modal and risk managed movement. More consistent ambient exposure; reduced risk. Tight chain of custody, enhanced traceability. Trained experienced operators – SOPs & GDP. Option to store off-site, shorter lead time to market. Single source shipping & tracking solutionprovider. Optimise the transport mode; right cost distribution. Ahead in reach to remote markets; increase capture. Min/max or Online monitoring options. Improved contingency planning & assured options.

47. Multi Modal Connectivity

48. Documentation and routing

49. Consolidation of handling

50. Air Express for fast track.

51. ‘Pit-Stop’ Express: Surface mode

52. Milk-run Express: Reefer Fleet.

53. Active cooled Boxes remote loads

54. Optimised Routing, multi-modal options.

55. Both innovative & conventional modes.

56. Single connected Chain of Custody.

57. Brand Assurance and Quality Assurance.

58. Life cycle Management.Bio-Pharma ExpressMulti-modal

59. Bio-Pharma ExpressMulti-modal First level bulk evacuation from Production unit to a cold storage Facility. Break Bulk facility for onward dispatch per demand pull. Dispatch to receivers; optimise modes of transport: via Air only for urgent shipments. via Surface with Ice Bank replenishments; ‘Pit-stops’. via Surface using mobile reefer boxes; Active boxes. Via Reefer Fleet; Milk-run or Point to Point. Delivery direct to stockist premise. Demand mapping and forecasting. Unified chain of custody in total supply chain. Direct access storage for all pan-India orders. Inventory management through product’s life cycle.

60. Pharma Industry Volumetric growth in last decade including Bio-pharma Implications Storage: Greatly increased need for +2°C to + 8°C storage. Storing and handling vaccines in secondary packaging will become increasingly impractical. Move towards palletized storage. Distribution: Move towards bulk distribution containers or refrigerated trucks. Management: Strengthen logistics management and QA procedures.

61. Pharma Talk Need for Change in Packing Introduce an un-insulated tertiary pack: Insulated shipping containers take up too much space (Bulking factor 3.5 to 7.5 times secondary packaging). Existing secondary packs are too small for mechanical handling at primary level. Therefore: Some form of tertiary packaging is needed: A carton containing multiple secondary packs, ideal. Shrink-wrapped secondary pack not robust enough.

62. Distribution technology First stage distribution: Traditional cold boxes will be phased out. Refrigerated trucks may be OK in countrieswith good infrastructure and good roads. But insulated passive bulk containers will solve the problem in many settings. Other implications: PCM / chilled packs will require refrigeration. Larger pallet-enabled delivery vehicles will be required. Tail lifts and/or dock levellers will be needed.

63. Associated operational changes Order picking at primary level: Wherever possible orders will be picked in large packs. Bulk breaking will be minimized. Orders pre-assembled into passive containers and kept inside the cold room until the delivery date. Packed crates/cartons may be bar-coded to assist with order tracking down to intermediate store level. Inventory Management: Stock in pallet stores cannot readily be inspected. Professionally developed and supported inventory control software, with accurate pallet location data will be essential.

64. Components of latent heat storage Energy cannot be destroyed or created – it can only change from one form to another.

66. Make/Break Molecular Bonding.

67. Solid to Liquid – Endothermic

68. Absorbs Energy (Heat).

69. Liquid to Solid – Exothermic

70. Releases Energy (Heat).In case of Melting Ice: the ice-water mix remains at 0 ºC until all phase change completes

71. How/What PCM?Harnessing the Force of the Molecule Four Phases of Matter. (4th phase is plasma – atomic forces) Control the temperature zone when a material makes or breaks the Molecular Force of attraction. PCM can be Organic and synthetic mixtures. Is a method to store energy at differing desired levels.

73. Maintains a desired steady state temperature profile.

74. Energy stored and output from 170 KJ to 300 KJ per kg.

75. Offers a wide array of thermal applications.When water freezes, energy is released to surroundings. When ice melts, energy is absorbed from surroundings. PCM is like ‘ICE’ at controlled, desired temperature levels (example: ice that melts at +20 ºC)

76. Other Innovation

77. Actively Cooled or Passive Cooled inner city distribution Other Innovation Active Boxes

78. Thank You Fini “An ideal supply chain is one that ensures that the limits of science are not constrained by the limits of systems.” — Dr Orin Levine