Packaging, supply & logistics
material is therefore rarely a simple substitution exercise; it often requires manufacturers to revalidate entire packaging systems before introducing them to market.
Martin Pearl, senior engineering consultant at
Team Consulting, says the longevity of materials such as Tyvek and PETG results from decades of optimisation rather than inertia: “Since its first use in the late 1960s, Tyvek has delivered a reliable microbial barrier system which is compatible with proven and affordable sterilisation techniques. “PETG was adopted in the early 1980s, and the two have been developed to bond readily with a peelable seal. Since then, there has been continuous development to optimise the two materials as a packaging solution.”
For new materials, competing with that established performance is a formidable challenge. As Pearl explains: “New alternatives will have to compete with this well-established and well-understood product and will also have to compete with the optimised manufacturing processes. This is a tough set of attributes to replace with alternative novel materials and will only take place if a potential user commits significant time and cost to finalise the development through to full production.” Validation represents one of the greatest barriers to adoption. New materials must demonstrate equivalent performance during seal integrity testing, accelerated ageing and compatibility studies, and distribution simulation testing that subjects packages to temperature fluctuations, humidity and mechanical stresses. If alternative materials cannot tolerate accelerated ageing conditions, manufacturers may be forced to undertake real-time shelf-life studies, extending development timelines by months or even years.
Sterilisation methods further complicate material selection. Traditional packaging systems have largely evolved around ethylene oxide (EtO) sterilisation. Still, growing concerns over emissions and occupational health are encouraging manufacturers to investigate alternatives such as vapourised hydrogen peroxide and electron-beam sterilisation. According to Pearl, this shift could prove significant: “This could open the door to other materials which can stand radiation but did not do well with hot, steamy conditions required by EtO processes.”
Where sustainability is gaining ground While wholesale replacement of established sterile barrier materials remains challenging, manufacturers are making measurable progress elsewhere. Rather than attempting to reinvent primary packaging, many organisations are focusing on reducing the amount of material used in the first place.
Pearl believes this pragmatic approach is currently delivering the greatest gains. “The areas where more sustainable materials can be sourced are leading to
www.medicaldevice-developments.com
material substitution – replacing fossil fuel-derived carbon with organic carbon, and ‘right sizing’ – ensuring there is no waste volume, and therefore material in the packaging.
Right sizing should lead to less material in the packaging and therefore reduce transport costs. Design optimisation extends beyond simply shrinking a carton. Multi-layer packaging systems allow engineers to adopt lower-impact materials progressively as packaging moves further away from the sterile barrier. “As the majority of medical device packaging has more than one layer, greater use of lower integrity materials can be considered as the layers move out from the primary containment nearest to the device,” Pearl explains. “However, each layer material choice must be carefully analysed for risks incurred in material choice.” Other opportunities require little technological innovation but can still deliver tangible environmental benefits. Where regulations allow, Pearl points to digital instructions for use as one example: “One way to reduce materials in packaging is to provide only electronic IFUs. No bulky leaflets in the packaging, which are thrown away even before they are read.” These relatively modest interventions may lack the headline appeal of novel biomaterials, but they demonstrate that meaningful environmental improvements do not necessarily depend on replacing the sterile barrier itself. Instead, many of the most immediate gains lie in reducing unnecessary material, improving transport efficiency and optimising packaging architecture without introducing additional clinical risk.
The bigger question: reuse or recycle? Even so, Mahmood Bhutta, professor of sustainable healthcare at Brighton and Sussex Medical School, argues that focusing exclusively on packaging materials risks missing the wider picture. According to published life-cycle assessment research, packaging contributes a relatively small proportion of a medical device’s overall carbon footprint. “Typically, it only
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Right sizing should lead to less material in the packaging.
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