The document summarizes the challenges and solutions involved in implementing a passive temperature controlled air supply chain for pharmaceutical cold chain distribution on a global scale. It discusses the need to change from active to passive solutions due to cost and availability issues. It then outlines some of the major challenges faced, including pushback from origin sites, stocking production sites, import customs issues, transporting varied units, and getting pods through airport security. It describes the solutions developed to address these challenges, such as demonstrating cost savings, managing inventory through freight providers, storing in free trade zones, accommodating varied pallet configurations, and familiarizing customs officials. It provides an example where temperature control was maintained during a two week warehouse error.

1. Pharmaceutical Cold Chain Distribution
5th
Annual Conference
London 1st
& 2nd
December 2010
The Implementation Of A Temperature
Controlled Air Supply Chain

2. What will we
look at today?
• Why the need to change
• The scale of the problem
• The current solution
• The possible solution
• Challenges faced
• How we overcame the challenges

3. Why the need
to change?
• Patient wellbeing
• Products being rejected following
temperature excursions using alternative
solutions
• Regulatory pressure
• Manufacture in varied global locations
• Distribution via multiple global hubs
• Markets in various climatic regions

4. The scale of
the problem
• Global manufacturing capability
• Global market distribution
• One-way supply chain flows
• Varied skill set
• Average low in Reykjavik -2 C
• Average high In Mumbai +42 C
• Dubai regularly over +50 C

5. The current
solution
• Active temperature control solutions such
as Envirotainers
• Advantages
• Reliability
• High quality
• Support
• Disadvantages
• Cost
• Availability
• Require intervention

6. The possible
solution
• Passive temperature control solutions –
Insulated Shipping Systems – “Pods”:
• Advantages
• Availability
• High quality
• Reliability
• Cost
• Disadvantages
• Inventory issues
• Training required
• Security at airports

7. Challenges
faced - 1
• Pushback from origin sites on the grounds
of:
• Purchase cost
• Inventory management
• Storage cost
• Additional workload for warehouse
staff

8. Challenges
overcome - 1
• Pushback from origin sites on the grounds
of
• Purchase cost
• Demonstrated cost savings over current
solution
• Inventory management
• Used freight provider to manage
inventory
• Storage cost
• Part of inventory management solution
• Additional workload for warehouse
staff
• Can build and load a pod in 10 mins so
no real workflow impact

9. Challenges
faced - 2
• “Stocking up” production sites
• Import Customs issues
• Transportation to site
• Variety of unit
• Training of loading staff

10. Challenges
overcome - 2
• “Stocking up” production sites
• Import Customs issues
• Site storage in a free trade zone
• Transportation to site
• Accurate production plans
• Variety of unit
• Work through pallet configuration and
find best fit
• Training of loading staff
• Variety of people, (internal,
manufacturer and external) carried out
training

11. Challenges
faced - 3
• By far the biggest challenge is getting the
pods through airport security
• Too big for many x-ray machines
• Customs unfamiliar with concept so
want to open unit, thus breaking the
integrity of the control chain

12. Challenges
overcome - 3
• By far the biggest challenge is getting the
pods through airport security
• Too big for many x-ray machines
• No single solution to this problem. In
some areas we x-ray the product then
pack the pod, in others we use the
“known shipper” system
• Customs unfamiliar with concept so
want to open unit, thus breaking the
integrity of the control chain
• Invite Customs to factory or loading
premises to familiarise them

13. Experience
so far
• So far we have experienced only one
excursion on our 15 to 25 product
• Product went from Germany to Dubai and
was left in error in a normal warehouse for
2 weeks
• Temperature was maintained below 25 for
the validated period plus 2 days
• Warehouse temperature was +65 for long
parts of the day
• Internal temperature rose to 36 and stayed
there
• The combination of data on the shipment
and the control on the maximum
temperature allowed us to put a case for
release to our Quality.

14. Thank you!