Return and Reuse of Shipping Sy stemsEveryone’s a cold chain winner!
New drug development is accompanied by formidable challenges, both for biopharmaceutical research companies pursuing the next generation of products, as well as the clinical supply chain industry, to which responsibility for packaging, labelling, storing and delivering IMP for global clinical trials has been outsourced.
In addition to their cost and complexity to develop and manufacture, vaccines must be stored, transported and maintained at controlled temperatures in a cold chain environment. New guidance and regulations such as EU GDP and Annex 15 emphasise the importance of good temperature control. The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest calibre – from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site.
One aspect of the supply chain process under discussion is the value of a ‘return and reuse shipping system’. In recent years the industry has seen a shift away from traditional Expanded Polystyrene (EPS) water-based shipping solutions to smaller, reusable, shippers with Vacuum Insulation Panels (VIP) and Phase Change Materials (PCM). Sponsors are demanding more robust systems and also have an increased awareness of the cost of disposal. In some EU countries such as Germany, which is the largest clinical trial supply and logistics market in Western Europe, it can cost twice the purchase price of a water-based shipper to dispose of it responsibly. Single use systems also create difficulties at the clinical site with ‘waste build-up’ and present major challenges for smaller sites with limited storage space.
EU countries such as Germany, which is the largest clinical trial supply and logistics market in Western Europe, it can cost twice the purchase price of a water-based shipper to dispose of it responsibly.
How can a ‘return and reuse’ program benefit parties to the supply chain?
- Reduced waste build-up
- Less storage space required to store waste until destruction
- Easier manual handling due to smaller shippers for the same payload space
- Less excursion risk due to increase in shipper performance
- No waste disposal costs
- Shorter lead times
- Lower outbound freight costs due to smaller shippers for same payload space
- Significant cost reduction when compared to purchase cost of the equivalent shipper
Clinical Supplies Logistics Providers:
- Level load week for dispatch as
- higher performance allows shipping over weekends
- Less excursion risk and associated burden of investigations
- Supporting a green initiative
- New revenue stream from returning empty shippers
Of course the real benefit is related to the patient. Utilizing a high performing, robust, reusable shipping system reduces the chances of a temperature excursion and increases the chances a shipment getting to the patient on time, in full.
To ensure success, the defined process must be kept simple to enable the sites to return the shippers with minimum effort. One must consider the process from a site perspective, and every site is different. Add to this the need for instructions to be in the local language where clinical trials are being conducted in remote locations. Ensure that stakeholders are engaged early in the process so that they realize the benefits and also what is expected of them. Open communication is key to the success of a reusable program, particularly at the outset when parties to the supply chain are on a steep learning curve. Over time the process can be streamlined and refined to ensure maximum success.
To find out more about how a shipper return & reuse program can work for clinical trials, access Fisher Clinical Services’ recent webinar. Find out more about the challenges faced in setting up a shipper reuse program, reuse models that can be adopted, and the benefits of a successful program to the various parties involved. Results show that when a robust returns process is in place, everyone’s a winner!
About the Author:
Royce joined Fisher Clinical Services in 2015 as the Global Cold Chain Technology Lead. Royce is originally from New Zealand and holds a masters degree in Biotechnology and Bioprocess Engineering. He started his career over 18 years ago with Big Pharma and has worked in contracting and consulting roles for many of the major pharma companies across the UK. He is a global expert on temperature controlled distribution, with regular contributions to technical papers, reports and conferences for organizations such as the Parenteral Drug Administration and IQPC. Royce is currently responsible for driving cold chain initiatives and increasing the cold chain distribution expertise across the business. Outside of work, Royce is a dedicated father of 2 and avid fan of the All Blacks and Black Caps.
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