SCA Cool Logistics

Case 1 - Chiron

Chiron Biopharmaceuticals, one of the industry's leading biotechnologists has dedicated more than 20 years to offering solutions for the prevention of human suffering, caused by disease.

In 2005, SCA Cool Logistics was presented with the opportunity to develop a range of temperature controlled packaging solutions for their Proleukin and (first to market) TOBI product, that would enable Chiron to continue supplying these market-leading pharmaceuticals in a secure cold chain.

After an intensive protocolling phase, SCA Cool Logistics came away with the following development and qualification requirements:

• A 48hour “National” delivery package, able to maintain a product
temperature of between +2°C to +8°C to hold one course
of either Proleukin or TOBI

• A 72hour “European” delivery package, able to maintain a
product temperature of between +2°C to +8°C to hold one
bulk presentation of either Proleukin or TOBI

• Both requiring triplicate qualification testing.

The ambient profiles used in the development of each of these solutions were built during the collaborative protocolling process and relied on the 3 year ambient study that SCA Cool Logistics had undertaken, combined with the data collected at Chiron, referencing their specific routes.

To ensure cost was considered during development, without it lowering system quality, it was decided that each system be developed with separate summer and winter packaging configurations. This meant that internal components were kept to a minimum, at the cost of a once-yearly switch in the internal packaging components layout.

During the initial development and testing phase, it became clear that although a good efficiency could be achieved using a single packaging solution for the 48 hour system for both of the drug presentations, it became necessary to develop separate solutions for the 72 hour Proleukin and TOBI package requirements, due to the pre-specified bulk carton sizes.

With Chiron using a third party logistics provider, documentation and training support was considered necessary and SCA Cool Logistics began a training programme in conjunction with Chiron, to ensure that their logistics provider was handling and packaging the systems in a way that would not invalidate the qualification work.

This support programme is still an ongoing process and further sessions occur as packages alter, due to season changes, or as additions are made to Chiron’s range.

Case 2 - Aptuit

Aptuit approached Cool Logistics with the design brief for their client, who were running a global clinical trial. The trial kits needed to be stored between +2°C and +8°C during transit to the trial sites.

Dummy kits were delivered to our lab for design and development of the temperature controlled packs and we were able to reach the solution in 10 working days. The design solution contained standard parts previously used by Aptuit for other shipping configurations. The design from the development report was incorporated into the protocol by Aptuit’s client.

Once the approved protocol was received, the Operational Qualification was run and the Qualification report sent out. SCA Cool Logistics also sent a sample of the system, along with an animation of the assembly to Aptuit, so that the assembly training could be performed across Aptuit’s global distribution network, prior to the trial starting.

Following a review of the supply chain for the temperature controlled packaging, we have implemented a plan to manufacture the shippers and hold stock of the CoolPacs at a local SCA site in Livingston, for delivery to Aptuit’s Bathgate site. This has enabled flexible supply and a reduction in lead times and transport costs.

Case 3 - Wyeth Local Supplies

This large pharmaceutical company realised that they were buying temperature controlled packaging from five suppliers within Europe. Each supplier was delivering into different affiliates and in some cases, charging widely varying prices, with some affiliates buying from three suppliers.

To simplify the supply chain through standardisation and to gain economies of scale, the business was put out to tender. Following a consultation exercise, we developed the customer requirement to the stage where we could start extensive design work. Upon evaluation, SCA Cool Logistics was selected as the best supplier, with the best offering.

The small, medium and large systems are now in use for national distribution from our customers' sites and their export shipments are using our CubePall systems for deliveries to 45 countries from Bahrain to Venezuela. The solutions are now also being adopted by other non-European countries, such as Egypt and Turkey.

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