Packaging, supply & logistics
Sterilisation equipment market, EU5, revenue ($m), 2018–33 1,200
1,000 800 600 400 200 0 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 Source: GlobalData Ultraviolet sterilisers
impact on susceptible materials than, for example, vaporised hydrogen peroxide (VHP). Due to the level of oxidation, VHP is not recommended for use with paper-based materials and can cause some embrittlement of polyamides. Another gas sterilant, nitrogen dioxide, is incompatible with cellulose-based materials and there is a risk that it will be absorbed into adhesives.
Incorporating any of these technologies directly in the packaging line will impact packaging design, which must facilitate the sterilisation process. Gaseous sterilisation methods, for example, may require a portion of the sterile barrier to allow for gas penetration, unlike radiation sterilisation. There will also be an effect on factory layout. Most gas-based modalities can be set up using small-scale equipment, but their use can be dangerous; EO, for example, is flammable, explosive and carcinogenic, so it may require extra safety measures. Radiation modalities would have a major impact on line layout due to energy and safety requirements.
The traditional sterilisation model of shipping unsterile products to third-party sterilisation vendors endured largely unchanged for a long time, suggesting that it worked well and met the needs of the industry, and technologies such as EO were widely used. It is only recently that attitudes have changed. “EO sterilisation is generally considered to be very gentle on materials, so it works for most medical device applications,” says Burgess. “Other sterilisation modalities, including some of the newly developed options, are often limited by either their ability to sterilise a device or because they are not compatible with the materials that comprise the device.” “Traditional third-party sterilisation can offer scale and expertise in specific modalities and provide regional capabilities and capacity,” remarks Anderton. “For many companies, using a third party avoids the need for the large capital investment in sterilisation equipment that is required and may not be financially viable for smaller medtech manufacturers or low-
92 Physical sterilisers Chemical sterilisers
volume products. Additionally, many companies do not have the in-house expertise required to manage all aspects of sterility assurance and rely on the competency of third-party suppliers.”
Nevertheless, the potential downsides of the legacy model are increasingly visible, prompting more companies to look at in-line processes. “The use of traditional third-party sterilisers may lead to increased costs and lead times due to transportation and logistics, scheduling, product testing and release, as well as added financial risk from take-or-pay contracts with fixed volume and price commitments where you pay regardless of whether they are used,” Anderton continues. “Shipping product out increases the number of times it is handled prior to going on the shelf, which may reduce manufacturing yield depending on the robustness of the device, its packaging, and the handling practices of the shipper and sterilisation vendor,” Burgess adds. “Pulling this process in would tend to have the opposite effect.”
Both also point to the sustainability benefits of in-house sterilisation processes, which so often go together with cost savings. At a very basic level, the elimination of shipping and handling stages, as well as the additional packaging needed for transport to an external sterilisation partner, would be a significant gain in terms of sustainability. Reducing transportation has a direct and immediate benefit for a company’s environmental footprint, though there are also potential gains to be found in energy and water consumption, waste and process emissions. “Bringing sterilisation in-house can create a meaningful competitive advantage with faster lead times that enable products to get customers and patients sooner while offering operational efficiencies that reduce excess inventory and improve total cost,” says Anderton. With every passing month, this win/win equation seems to be gaining traction, so in time the in-house model may well become the norm. ●
www.medicaldevice-developments.com
Revenue ($m)
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