Pharmaceutical Cold Chain Distribution5th Annual Conference

London 1st & 2nd December 2010

The Implementation Of A Temperature Controlled Air Supply Chain

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

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

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

The current solution

• Active temperature control solutions such as Envirotainers

• Advantages• Reliability• High quality• Support

• Disadvantages• Cost• Availability• Require intervention

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

Challenges faced - 1

• Pushback from origin sites on the grounds of:

• Purchase cost• Inventory management• Storage cost• Additional workload for warehouse

staff

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

Challenges faced - 2

• “Stocking up” production sites• Import Customs issues• Transportation to site• Variety of unit• Training of loading staff

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

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

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

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.

Thank you!