Packaging, supply & logistics
Sterilisation equipment market, North America, revenue ($m), 2018–33 2,000
1,500
1,000
500
0 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 Source: GlobalData Ultraviolet sterilisers
several years of supply chain and regulatory pressures, many companies are looking to localise or insource sterilisation capacity to reduce supply chain risk, improve overall lead time, and lower operational and transportation costs.
“For some, that means qualifying local sterilisation suppliers, installing sterilisation equipment on site, or implementing in-line sterilisation directly into the manufacturing process,” he adds. “Many companies are evaluating in-house and in-line sterilisation as they review their network architecture.”
Reshaping the packaging line The move by medical device companies to bring sterilisation technology directly onto or immediately after the packaging line allows for smaller, more frequent batches to pass through the process and be shipped, as opposed to larger batches going in bulk to third parties. This eliminates the need for shipping products to, and storing them at, external sterilisation facilities.
“This change is driven by the development of new sterilisation modalities, a desire among regulators to reduce environmental risks associated with the use of ethylene oxide sterilisation, for example, and vertical integration to improve process control, external vendor capacity, and opportunity to reduce manufacturing costs,” observes Dan Burgess, associate senior fellow, packaging engineer, Boston Scientific. “This shift to bring sterilisation in-house is largely driven by a need for greater supply chain resilience and predictability,” concurs Anderton. “Companies want less risk with greater agility, shorter lead times, and more sustainable operations with smaller transportation footprint. The maturation of various sterilisation technologies is making in-line architecture solutions increasingly attractive.”
So what does this in-line process look like? That depends to a great extent on which technologies are deployed. In-line e-beam, X-ray and advanced heat/UV sterilisation systems are all on the table.
www.medicaldevice-developments.com Physical sterilisers Chemical sterilisers
High-energy electron beam (e-beam) technology is a well-understood and mature technology. Like EO and other radiation-based modalities such as gamma and X-ray, it has been around for decades and is recognised by the FDA as a Category A sterilisation method. Crucially, it is a technology that has greatly improved in terms of key criteria – including system throughput and stability – in recent years, and newer compact, low-energy emitters have opened up great potential for in-line aseptic packaging and equipment sterilisation. “Integrating the sterilisation process directly into the manufacturing line can enable more efficient processes, especially when the dose of radiation methods or the time for the cycle of steam or gas methods can be reduced through sterilisation of the product in the primary package,” says Anderton. “In-line may also enable parametric release allowing the manufacturer to ship the product directly after sterilisation.” E-beam is regarded as one of the faster and more controllable sterilisation options compared with gamma, which uses cobalt-60 sources and raises different radiological safety considerations, though the latter is certainly effective. E-beam uses high- energy electrons to destroy contaminants directly, as they collide with electrons with enough energy to break down the bioburden of bacteria or fungi on the surface of a product, steadily reducing its energy with each collision. Gamma rays, however, penetrate further into a material and continue to trigger high- energy electrons.
E-beam and X-ray radiation modalities are similar regarding the equipment and infrastructure required to operate them. Both require large facilities and large capital investment but provide very quick sterilisation processes. Advanced heat methods require a low capital investment but are limited by material compatibility. UV sterilisation for sterilising surfaces is not applicable to devices that require the sterilisation modalities that penetrate the packaging and device. Chlorine dioxide is an effective gas sterilant, so it requires porous packaging, and there is less oxidation
Opposite: Production lines for many medical devices could soon include in-line sterilisation.
91
Revenue ($m)
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