In a world that is increasingly waste conscious, the appeal of reusable and recycled materials is growing in many industries, not least the pharmaceutical sector. Reusable temperature-controlled packaging for investigational medicinal products is an option more companies are choosing in their logistics strategies for clinical trials. We hear from industry sources about the impact this is having on distribution processes.
The pharmaceutical industry is not alone in feeling the impact of the growing emphasis on sustainability as a defining factor in business practices. It is in regard to strategies for packaging solutions that the biggest efforts have been made to improve the industry’s green credentials, not least because this is the area in which the biggest advantage can be gained. As in many other industries, there has been a realisation that sustainable practices can have a positive impact on costs, which encourages companies to explore the potential of manynew packaging solutions.
When it comes to improving sustainability in the area of packaging, the most obvious avenues to pursue are the use of a higher proportion of recyclable materials and to design packaging that uses less material. There is, however, a growing focus on reusable packaging, and this trend is particularly noticeable in clinical trials, where frequent shipments to investigation sites are required.
Given the nature of the products being shipped, and their high value, it is important to maintain the integrity of the product, so the design and materials used must fulfil the highest quality standards for temperature-controlled packaging for investigational medicinal products (IMPs). Any attempts to incorporate reusable packaging into the cold chain must not come at the expense of the safety and security of the products shipped.
"We are trying to reuse as well as recycle, partly because it is more cost-effective if you can reuse the temperature-controlled boxes in the cold chain. We started using reusable packaging in the US in 2011, and it has worked very well in terms of cost benefits and the quality of the product," says a source at a large pharmaceutical company actively engaged in a return and reuse programme for clinical trials.
Building bridges, learning lessons
When it comes to implementing a return and reuse programme across many investigation sites, often in many different countries, there are a great many challenges to address. The complexity of achieving standard processes across multiple countries in Europe, for instance, makes it hard to implement such a programme quickly. For this reason, companies are likely to develop these programmes incrementally, learning steadily about the unique challenges in each jurisdiction and developing ways to improve compliance.
"Last year, we began rolling it out in Europe, where there was no good solution on the market, although that has changed rapidly over the last two years. In the US, it was relatively easy because it is a single country. Everyone wants to think of Europe as one big country, but it is not. There are many differences in the collaboration process with hospitals in different European countries, and the service-level from carriers also varies," the source continues.
"It is much harder to roll out reusable packaging in Europe, and it is certainly much harder to get the packaging back from the various trial sites, even though shipping to the hospitals is easy. In the US, we have a return rate of 90%, but in Europe at the moment we have an average return rate of only 70%, which is not enough to have a cost-efficient system in place."
Any return and reuse programme is highly dependent on the willingness of carriers to engage in a partnership with the pharmaceutical companies in order to provide a cost-effective solution. It is also highly dependent on the willingness of investigation sites to comply with the parameters of a programme defined by the pharmaceutical company. In Europe, for instance, there is a noticeable variation in the compliance rates, with countries in northern Europe performing significantly better than their neighbours to the south.
What can be done to improve such programmes and, therefore, realise the full benefits that they can deliver in terms of cost savings? The answer, it seems, is to ensure that every party that has an impact on the success of a programme is fully aware of the reasons behind it and the potential benefits it can bring.
"The most important thing is that all stakeholders must be involved," says our industry source. "The trial sites must be willing to participate. The carriers are good at delivering, and they can also do the return part, but you can’t pay a premium rate for shipping an empty box if you want to be cost-efficient. There is also an issue with the process for unpacking at individual sites, which may vary greatly. In some cases it is possible to collect the empty boxes immediately, but in others it may be the next day at best or even a few days later.
"That makes it a very complex process, so you need a flexible system in place with the transporter, while also keeping it very simple in terms of the procedures with which the trial sites must comply. We were among the first in the industry to try reusable packaging; we explained the benefits of it to the sites and showed that we understood the challenges from their point of view. We also made sure we understood what services the carriers could offer at reasonable prices."
For carriers taking part in return and reuse programmes, there is strong motivation to develop workable solutions. Reusable packaging is set to be an increasingly important feature in the logistics activities of companies in a broad and diverse group of industries, not solely the pharmaceutical sector, and all will be driven by the need to achieve greater efficiency in their supply chains.
The logistical needs of pharmaceutical companies conducting clinical trials are likely to provide some of the most demanding parameters in terms of compliance, product integrity and cost pressures. For this reason, it provides an excellent opportunity for carriers to develop and perfect solutions that can then be easily adapted to suit customers in other industry sectors.
The sound business case for reusable packaging
There is little doubt that increasing the use of reusable packaging in the clinical trials supply chain can ultimately yield cost savings, even though such savings are easier to achieve in some geographical regions than others.
Return and reuse programmes may not deliver their full cost benefit immediately, but the initial stages will be important in establishing the processes that will ultimately maximise cost-efficiency, as well as considerably enhancing sustainability in the supply chain.
Furthermore, the increasingly sophisticated designs of reusable packaging solutions, which may feature temperature monitoring and control systems alongside high-performance materials (see The building blocks of reusability), are likely to achieve a higher level of product integrity throughout the cold chain.
"The cost saving is enough to justify continuing the practice of using reusable packaging. It is also true that reusable temperature-controlled IMP packaging is more robust and goes through many transport cycles, and its performance is better than that of a standard box. We lose less product and there are fewer temperature excursions," says one well-placed source.
As return and reuse programmes become more mature, they reveal more benefits, particularly in regard to cost savings, which are defined by many factors above and beyond the shipping rates charged by carriers.
Better performance that results in the loss of less product will inevitably have a beneficial impact on costs, but many designs of reusable packaging also make it possible to use more phase-change materials (PCM).These are designed to help to keep temperature-sensitive packages within defined temperature ranges.
"Reusable boxes mean we can use fewer gel packs and more PCMs, so the product is better protected and the boxes are easier to handle. This makes the ‘pick and pack’ process at the warehouse easier. All these factors lead to hidden cost savings that we see over time. Another important factor is that the boxes are readily available; it is only necessary to do the proper validation of them to fit a desired temperature profile."
In terms of sustainability, recyclable packaging solutions certainly have merit, but in the clinical trial supply chain they do provide challenges for trial sites. There are cost and workflow implications for hospitals receiving shipments in containers that require recycling, and these can be burdensome.
Another factor that may drive pharmaceutical companies towards reusable packaging is regulation. For example, in the wake of the publication of the latest ‘Good Distribution Practice of Medicinal Products for Human Use’ guidelines, which came into effect in Europe in recent months, some packaging suppliers have put more emphasis on reusable solutions. Although the guidelines do not specifically focus on reusability, they do introduce new requirements for the shipment of temperature-sensitive drugs in an attempt to improve supply chain security.
"Speaking to people in other companies, we see more and more of them are looking at this kind of packaging, in part because of the need to implement GDP guidelines in Europe. As regulations get stricter, the value of reusable packaging will increase. We could use recyclable boxes, but there is cost involved in that for the trial site," says our industry source.
"We are seeing some countries – Germany and Romania are two of the most prominent – where sites may not accept products if we don’t take the boxes back. We may well see other countries follow suit."
There can be little doubt that growing pressure from different stakeholders in the clinical trials supply chain – crucially, the pharmaceutical companies and the investigative sites with which they work – will soon result in greater collaboration with packaging manufacturers and shippers to make return and reuse programmes the industry standard.
The building blocks of reusability
Reusable temperature-controlled packaging not only has ecological benefits, but can also be a cost-efficient option compared with disposable packaging. There are many components that can be combined to create reusable packaging to suit diverse needs.
These include:
- an aluminium-coated polyurethane foam pocket that is an integrated part of the exterior cardboard packaging, which can provide protection at a stable temperature for 24 hours; it is easy to wash and disinfect after each use, and can accommodate extra gel packs for additional cooling
- semi-active intelligent temperature-controlled containers incorporating temperature regulation devices that respond to changes in external temperature
- vacuum insulated panels that guarantee stable product temperatures for up to five days and are ten times as efficient as standard polystyrene foam insulation
- expanded polypropylene containers that offer better thermal protection and greater strength than standard poly boxes.