Packaging, supply & logistics
Though it is not the norm for sterilisation to be an integral part of the packaging line, more device manufacturers are considering this approach as a replacement for the legacy model of shipping unsterile products to external partners. Jim Banks looks at how e-beam, X-ray and other sterilisation processes are being brought in-house, with insight from Travis Anderton, Becton, Dickinson and Company’s (BD) VP for sterilisation, and Dan Burgess, associate senior fellow and packaging engineer, Boston Scientifi c.
Sterile at the source A
new trend in the medical device industry continues to gather pace. More manufacturers are reassessing how they sterilise their products, as they seek to maximise efficiency and manage risk. The result is that many are pushing sterilisation technology directly onto the packaging line, rather than shipping products to a third party. Packaging and sterilisation have always been intrinsically linked within the industry. Packaging materials must allow chemical sterilisation to occur effectively but must also be able to withstand the impact of that process. The physical integrity of the barrier seals must be maintained and the performance of the packaging material itself must not be compromised.
Every sterilisation technique has its own unique requirements and potential effects on packaging materials, so it has been expedient to leave this complex process to external specialists. But times are changing. For example, there has been a push to revisit the status quo sterilisation modality – ethylene oxide (EO) – for most single-use disposable devices since the US FDA and EPA began re-evaluating emissions and safety concerns around ethylene oxide
90
(EO) facilities in 2018–19, prompting an industry-wide effort to identify alternative sterilisation methods and technologies.
There is increasingly heavy pressure on sterilisation processes to handle growing capacity, and along with a need to manage risk and improve efficiency in increasingly complex global supply chains, that pressure is pushing sterilisation into the packaging line. Becton, Dickinson and Company (BD), one of the world’s largest medical technology companies, produces more than 34 billion devices annually, around 25 billion of which require sterilisation, according to Travis Anderton, the company’s VP for sterilisation. BD has decades of experience and operates one of the industry’s largest distributed sterilisation networks to help it deliver essential medical products to millions of patients every day, so there is a strong incentive to remain at the cutting edge of technology and process development. “Sterilisation is a critical process in the medical supply chain that protects patients from the risks of infectious diseases caused by bacteria, viruses and fungi,” he explains. “Across the industry, we’re seeing companies rethink their sterilisation strategy. After
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