Pharmaceutical Cold chain Distribution

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

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  • Peltier Effect
  • Johns Hopkins Bloomberg School of Public Health
  • Pharmaceutical Cold chain Distribution

    1. 1. Pharmaceutical & <br />Bio Cold Chain Conference - 2011<br />Behind-The-Scene:Options for Bio Pharma Shipments<br />by Capt. Pawanexh Kohli<br />Founder, CrossTree techno-visors<br />
    2. 2. At 45,000 feet:10°F / -12 C<br />?<br /><ul><li>Ground transport for pick up.
    3. 3. Airport loading/handling prior to departure.
    4. 4. Air transport - Flight transfers.
    5. 5. Airport arrival delay pending release.
    6. 6. Ground transport for last leg delivery.
    7. 7. Storage option for out of hour arrivals.</li></ul>Passive Cooling with safety Margin and <br />Qualified packaging to counter extreme<br />Ambient Temperature variations in transit.<br />Mumbai<br />90°F 32°<br />Jaipur<br />111°F 44°C<br />Current Scenario<br />
    8. 8. The ChallengesAir mode<br />Wide fluctuation in external ambient.<br />Dynamic chain of custody.<br />Transit time limited due to cold chain system.<br />Routing limited via existing airports only.<br />Contingency “Plan B” options limited. <br />Volatility in air capacity and ATF.<br />
    9. 9. Typical Surface Network<br />Uses feeder service to consolidate.<br />Long haul with transit times extension.<br />Optimised routing via various touch points.<br />Door step delivery through last mile feeders.<br />Low cost option, mixed load option.<br />
    10. 10. Surface ModeDistribution Network<br />
    11. 11. Surface ModeDistribution Network<br />Operating Unit<br />
    12. 12. Surface ModeDistribution Network<br />Pick-up Point<br />Operating Unit<br />
    13. 13. Surface ModeDistribution Network<br />Pick-up Point<br />Operating Unit<br />
    14. 14. Surface ModeDistribution Network<br />Pick-up Point<br />Distribution Centre<br />Operating Unit<br />
    15. 15. Surface ModeDistribution Network<br />Feeder System<br />Pick-up Point<br />Distribution Centre<br />Operating Unit<br />
    16. 16. Express Distribution Centre<br />Pick-up<br />Feeder<br />Operating Unit<br />Surface ModeDistribution Network<br />
    17. 17. OR<br />Express Distribution Centre<br />OU<br />Feeder<br />Pick-up<br />Feeder<br />Operating Unit<br />EDC<br />Surface ModeDistribution Network<br />
    18. 18. OR<br />Express Distribution Centre<br />Express Connection<br />OU<br />Feeder<br />Pick-up<br />Feeder<br />Operating Unit<br />EDC<br />Surface ModeDistribution Network<br />
    19. 19. OR<br />Express Distribution Centre<br />Express Connection<br />OU<br />Feeder<br />Pick-up<br />Feeder<br />Operating Unit<br />EDC<br />Surface ModeDistribution Network<br />
    20. 20. OR<br />Express Distribution Centre<br />Express Connection<br />OU<br />Feeder<br />Pick-up<br />Feeder<br />Networked / Tracked<br />Operating Unit<br />EDC<br />Surface ModeDistribution Network<br />
    21. 21. OR<br />Express Distribution Centre<br />Express Connection<br />OU<br />Feeder<br />Pick-up<br />Feeder<br />Networked / Tracked<br />Operating Unit<br />EDC<br />Surface ModeDistribution Network<br />
    22. 22. Spoke<br />Origin - Destination<br />HUB<br />HUB<br />Spoke<br />Destination<br />Origin<br />Spoke<br />Networked / Tracked<br />HUB<br />HUB<br />Spoke<br />Spoke<br />Spoke<br />Spoke<br />Networked / Tracked<br />Spoke<br />Surface ModeDistribution Network<br />
    23. 23. Advantage Surface Network<br />Allows Inclusive logistics in future plant and distribution site planning<br />Superior planning of service expansions <br />Establish Quality Agreements between custodial stakeholders<br />Limits potential for a logistics logjam and a storage nightmare.<br />
    24. 24. Upping the Ante<br />It’s not just about developing safe and effective vaccines.... <br />It’s about getting vaccines to the right place, at the right time, in the right condition..... <br />and...that means delivery systems that are as advanced & innovative as the vaccines they support.<br />
    25. 25. ‘Pit-Stop’ ExpressRight Cost Solution<br />
    26. 26. Pit-Stop Process<br />Pickup Point<br />Dispatch OU<br />
    27. 27. Pit-Stop Process<br />Pickup Point<br />Dispatch OU<br />Enroute Touch Point<br />
    28. 28. Pit-Stop Process<br />Pickup Point<br />Dispatch OU<br />Enroute Touch Point<br />Waiting/Cooling<br />
    29. 29. Pit-Stop Process<br />Pickup Point<br />Dispatch OU<br />Enroute Touch Point<br />Waiting/Cooling<br />Re-Charge Needed?<br />
    30. 30. Pit-Stop Process<br />Pickup Point<br />Dispatch OU<br />Enroute Touch Point<br />Waiting/Cooling<br />Re-Charge Needed?<br />YES<br />
    31. 31. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />YES<br />
    32. 32. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />YES<br />
    33. 33. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />NO<br />YES<br />
    34. 34. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />Onward Transit<br />Receiving OU<br />Customer Out Reach Point<br />NO<br />YES<br />
    35. 35. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />Onward Transit<br />Receiving OU<br />Pit-Stop<br />Customer Out Reach Point<br />NO<br />YES<br />
    36. 36. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Replace<br /><ul><li>Shipper Chill Packs
    37. 37. Shipper Outer Seal</li></ul>Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />Onward Transit<br />Receiving OU<br />Pit-Stop<br />Customer Out Reach Point<br />NO<br />YES<br />
    38. 38. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Replace<br /><ul><li>Shipper Chill Packs
    39. 39. Shipper Outer Seal</li></ul>Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Record<br /><ul><li>Shipper Contents
    40. 40. Pit-stop Checklist</li></ul>Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br />Onward Transit<br />Receiving OU<br />Pit-Stop<br />Customer Out Reach Point<br />NO<br />YES<br />
    41. 41. Pit-Stop Process<br />Pickup Point<br />Onward Transit <br />Replace<br /><ul><li>Shipper Chill Packs
    42. 42. Shipper Outer Seal</li></ul>Dispatch OU<br />Seal Shipper <br />Enroute Touch Point<br />Replace Chill Packs<br />Record<br /><ul><li>Shipper Contents
    43. 43. Pit-stop Checklist</li></ul>Waiting/Cooling<br />Open Shipper<br />Re-Charge Needed?<br /><ul><li>Cargo Onward
    44. 44. Recharge Chill Packs</li></ul>Dispatch<br />Onward Transit<br />Receiving OU<br />Pit-Stop<br />Customer Out Reach Point<br />NO<br />YES<br />
    45. 45. Value added - Advantages<br />Multi-modal and risk managed movement.<br />More consistent ambient exposure; reduced risk.<br />Tight chain of custody, enhanced traceability.<br />Trained experienced operators – SOPs & GDP.<br />Option to store off-site, shorter lead time to market.<br />Single source shipping & tracking solutionprovider.<br />Optimise the transport mode; right cost distribution.<br />Ahead in reach to remote markets; increase capture.<br />Min/max or Online monitoring options.<br />Improved contingency planning & assured options.<br />
    46. 46. <ul><li>Centrally located hub function
    47. 47. Multi Modal Connectivity
    48. 48. Documentation and routing
    49. 49. Consolidation of handling
    50. 50. Air Express for fast track.
    51. 51. ‘Pit-Stop’ Express: Surface mode
    52. 52. Milk-run Express: Reefer Fleet.
    53. 53. Active cooled Boxes remote loads
    54. 54. Optimised Routing, multi-modal options.
    55. 55. Both innovative & conventional modes.
    56. 56. Single connected Chain of Custody.
    57. 57. Brand Assurance and Quality Assurance.
    58. 58. Life cycle Management.</li></ul>Bio-Pharma ExpressMulti-modal<br />
    59. 59. Bio-Pharma ExpressMulti-modal<br />First level bulk evacuation from Production unit to a cold storage Facility.<br />Break Bulk facility for onward dispatch per demand pull.<br />Dispatch to receivers; optimise modes of transport:<br />via Air only for urgent shipments.<br />via Surface with Ice Bank replenishments; ‘Pit-stops’.<br />via Surface using mobile reefer boxes; Active boxes.<br />Via Reefer Fleet; Milk-run or Point to Point.<br />Delivery direct to stockist premise.<br />Demand mapping and forecasting.<br />Unified chain of custody in total supply chain.<br />Direct access storage for all pan-India orders.<br />Inventory management through product’s life cycle.<br />
    60. 60. Pharma Industry<br />Volumetric growth in last decade including Bio-pharma<br />Implications<br />Storage:<br />Greatly increased need for +2°C to + 8°C storage.<br />Storing and handling vaccines in secondary packaging will become increasingly impractical.<br />Move towards palletized storage.<br />Distribution:<br />Move towards bulk distribution containers or refrigerated trucks.<br />Management:<br />Strengthen logistics management and QA procedures.<br />
    61. 61. Pharma Talk<br />Need for Change in Packing<br />Introduce an un-insulated tertiary pack:<br />Insulated shipping containers take up too much space (Bulking factor 3.5 to 7.5 times secondary packaging).<br />Existing secondary packs are too small for mechanical handling at primary level.<br />Therefore: Some form of tertiary packaging is needed:<br />A carton containing multiple secondary packs, ideal.<br />Shrink-wrapped secondary pack not robust enough.<br />
    62. 62. Distribution technology<br />First stage distribution:<br />Traditional cold boxes will be phased out.<br />Refrigerated trucks may be OK in countrieswith good infrastructure and good roads.<br />But insulated passive bulk containers will solve the problem in many settings. <br />Other implications:<br />PCM / chilled packs will require refrigeration.<br />Larger pallet-enabled delivery vehicles will be required.<br />Tail lifts and/or dock levellers will be needed.<br />
    63. 63. Associated operational changes <br />Order picking at primary level:<br />Wherever possible orders will be picked in large packs. Bulk breaking will be minimized.<br />Orders pre-assembled into passive containers and kept inside the cold room until the delivery date.<br />Packed crates/cartons may be bar-coded to assist with order tracking down to intermediate store level.<br />Inventory Management:<br />Stock in pallet stores cannot readily be inspected. Professionally developed and supported inventory control software, with accurate pallet location data will be essential. <br />
    64. 64. Components of latent heat storage<br />Energy cannot be destroyed or created <br />– it can only change from one form to another.<br />
    65. 65. Energy to Change Phase<br /><ul><li>Heat of Fusion
    66. 66. Make/Break Molecular Bonding.
    67. 67. Solid to Liquid – Endothermic
    68. 68. Absorbs Energy (Heat).
    69. 69. Liquid to Solid – Exothermic
    70. 70. Releases Energy (Heat).</li></ul>In case of Melting Ice: the ice-water mix remains at 0 ºC until all phase change completes<br />
    71. 71. How/What PCM?Harnessing the Force of the Molecule<br />Four Phases of Matter.<br /> (4th phase is plasma – atomic forces)<br />Control the temperature zone when a material makes or breaks the Molecular Force of attraction. <br />PCM can be Organic and synthetic mixtures.<br />Is a method to store energy at differing desired levels.<br />
    72. 72. Thermal Inertia<br /><ul><li>The tendency to retain or resist any energy level change.
    73. 73. Maintains a desired steady state temperature profile.
    74. 74. Energy stored and output from 170 KJ to 300 KJ per kg.
    75. 75. Offers a wide array of thermal applications.</li></ul>When water freezes, energy is released to surroundings.<br />When ice melts, energy is absorbed from surroundings.<br />PCM is like ‘ICE’ at controlled, desired temperature levels (example: ice that melts at +20 ºC)<br />
    76. 76. Other Innovation<br />
    77. 77. Actively Cooled or<br />Passive Cooled<br />inner city distribution<br />Other Innovation<br />Active Boxes<br />
    78. 78. Thank You<br />Fini<br />“An ideal supply chain is one that ensures that the limits of science are not constrained by the limits of systems.” — Dr Orin Levine<br />

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