Temperature Controlled Airfreight

Since the introduction of "new" Good Distribution Practice (GDP), there has been a lot of work by airlines to introduce temperature controlled services.

There are currently more than 30 airlines who offer a "pharmaceutical" service but not all services are created equally!

Services vary from basic to comprehensive: basic might be asking the manufacturer to arrange their own protection with the airline merely monitoring the shipment whilst comprehensive might include active temperature control on the aircraft and the provision of multi-temperature ground handling warehousing.

The critical thing here is to understand your product and its needs under GDP. You could then opt to temperature control across the whole route or perform a risk assessment and arrange transport on that basis.

Both options have their advantages and disadvantages. Full temperature control can add significantly to costs whilst a risk-based approach can lead to temperature excursions which tend to impact financially, operationally and reputationally.

Full temperature control can be achieved in 3 main ways:

1. Use of an active shipping system;

2. Use of a passive shipping system;

3. Reliance on the airline’s own control systems.

Active systems are extremely reliable but are usually at the expensive end of the spectrum. They are normally deployed in high value or critical situations where a temperature excursion cannot be countenanced. They do require careful handling and the system provider should be able to offer full support to ensure success.

Passive systems work very well when set up properly and when the shipping lane characteristics are understood. They have the advantage of requiring no intervention and can be booked as regular airfreight.

As mentioned at the start, airlines differ widely in what their "pharma service" offers so you should only go down this line if you fully understand what the airline is offering and where there may be gaps in their coverage; typically these gaps would be at the airline handling and ramp stages ie at the airport.

A risk based approach would need to encompass the nature of your product, the availability of stability data in the event of an excursion, the seasonal temperature profiles of the route you are taking as well as allowance for diversions and operational difficulties which the airline may encounter.

The main point to note is that Regulators and Quality personnel are not happy using stability data as a way of validating what they see as poor logistics practice. For example, if you were transporting product from India to Europe and regularly saw excursions during trans-shipment in Dubai, it would be considered poor practice if, rather than resolving the issues in Dubai, you continued to rely on stability data to release product despite the excursions.

At a recent meeting with a pharma manufacturer, they stated that they did not experience any excursions during transport thus they employed no special precautions. Given the route their products were taking, this was a surprising statement. However, when they confirmed that they did not use temperature monitors, it soon became apparent why they had "no issues". The moral here is that all shipments should be monitored en route, whether that is by monitors you supply or using loggers built in to vehicles, aircraft etc is up to you. The ones you supply tend to be easiest to manage and use since you have access to end-to-end data so can make any Quality decisions quickly and with confidence.

However, data from loggers can also be used to temperature map and risk assess routes. It can even be used to provide route or transport provider qualification ie documented testing with a high degree of assurance of meeting pre-determined acceptance criteria.

So, the use of loggers may highlight issues which you need to address but is also an opportunity to qualify your providers and prove that they are doing a good job for you, thus confirming the validity of your risk assessments.

The only way you can have confidence in what you are doing is to fully understand the risks involved in the actions you are taking then do all possible to mitigate those risks. At the same time, make sure you have timely and accurate temperature data so you can make an informed decision before releasing your products to market.

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Temperature Controlled Airfreight

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