Cold chain packaging and other Temperature Packing Systems (TPS) are used to maintain a constant temperature around pharmaceuticals during transportation. The flexibility of the TPS allows pharmaceuticals to be sent across Australia and internationally through all modes of transport. These include delivery vans, trains, trucks and planes.
Cold chain packaging that are suited for different scenarios.
- smaller courier shippers,
- larger bulk shippers,
- single-use shippers,
- long term industrial containers
- Long-lasting systems and
- shorter longevity systems
Multi-Use Cold Chain Packaging
Single-Use Cold Chain Packaging
Olivo Cold Chain Packaging
Elements of a Cold Chain Packaging System
Cold Chain Packaging Systems are composed of two elements:
- Insulated container
- Refrigerant
The insulated box is used as a barrier to the ingress of heat into the packaging system from the surrounding environment.
The refrigerant is conditioned at a specific temperature before packing out the system. Its purpose is to cool the internal space of the insulated container. Both elements provide the thermal longevity needed to keep the medicines “cool” for sufficient time for the transportation to be completed.
Qualification of Cold Chain Packaging System
Proper balancing of the insulation, the refrigerant and matching them to the expected ambient environment which the system will be exposed to, is done during a “Qualification Study”.
Like all pharmaceutical systems, Cold Chain Packaging systems must be qualified to regulatory health standards. Every country has its own regulation and in Australia these are governed by the TGA and State Health Departments. Industry guides assist in the harmonising of regulatory approaches.
CoolPac’s Cold Chain Packaging systems are pre-qualified to Australian and international temperature profiles (International Association of Safe Transit, ISTA) and pharmaceutical qualification approaches (International Association of Pharmaceutical Engineers, ISPE).
Active and Passive Cold Chain Systems
Distributing pharmaceuticals and vaccines across Australia, or beyond, will require a multi-faceted approach that may include active refrigerated systems and passive Cold Chain Packaging systems.
Active systems require motors, mechanical parts, batteries and/or fans for the system to work. If one or more of these active components malfunction or run out of power, then a temperature excursion will inevitably happen.
Passive systems require a refrigerant pack and an insulated container. They will exhibit typical behaviour for a certain time period in certain ambient conditions. After that a temperature excursion will inevitably happen.
Not all shipments are suited to an “active” refrigerated truck and not all shipments are suited to a “passive” Cold Chain Packaging systems. Each solution has strengths and weakness which are better suited to some scenarios rather than others.
Refrigerants used in Cold Chain Packaging Systems
There are many types of refrigerants that are used in Cold Chain Packaging systems. The main ones are listed below:
- Dry-ice
- water based gel bricks
- Phase Change Materials
Which one is best suited is dependant upon:
- the target temperature that the pharmaceuticals/vaccines must be maintained at
- the likely duration of the transport (plus a contingency)
- the likely thermal challenge exhibited by the ambient environment and
- the cost/importance of the medicines
