Packaging, supply & logistics
Packaging engineers must consider the size and weight of a medical device, as well as the storage and sterilisation method used, when selecting the appropriate packaging material.
In fact, more than 20 billion devices sold in the US every year are sterilised with ethylene oxide, accounting for approximately 50% of devices that require sterilisation. These devices range from wound dressings to more specialised devices, such as stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made from different materials. However, there are widespread concerns about the environmental impact of this popular sterilisation method. Following a risk assessment conducted by the Environmental Protection Agency (EPA) last year, the agency is proposing to limit the application rate for ethylene oxide to no more than 500mg/L of air, which would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below the Clean Air Act standard for elevated cancer risk, and forcing medical device manufacturers to reconsider their sterilisation processes. “If manufacturers consider sterilising at the sterile pack level, that will potentially allow them to use less ethylene oxide gas, because they would only have to get through one barrier to sterilise the contents of the package,” Burgess explains. “However, if a company has always done their sterilisation process at the final pack level, moving to sterilisation at the sterile pack level is a big change, because it will require new methods of handling the product.” There are many factors to consider: Do you have the right equipment? Is there going to be extra handling that might lead to a sterile barrier breach? “You need to evaluate your manufacturing process to assess whether or not that’s going to be a concern if you change where and when you’re doing the sterilisation,” Burgess advises. To help manufacturers address these challenges, the FDA has been proactively working with medical device sterilisers to reduce the amount of ethylene
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oxide they use while still effectively sterilising products to help ensure they meet the EPA’s standards – for example through an Innovation Challenge. Early observations suggest that some facilities have cut emissions from between 20–35%. Challenge participants are also exploring the potential for using alternative sterilisation methods, such as vaporised hydrogen peroxide, supercritical carbon dioxide and nitrogen dioxide for certain types of medical devices.
Technological innovations
Another development Burgess believes could impact the sterile packaging process in the coming years is computational modelling, which has high potential to reduce development time and packaging waste. “The traditional approach of physical prototyping, build and test is still prevalent in the industry,” he notes. “And while it’s a time tested and proven method, supply chain challenges and lead times mean it is taking an increasingly long time to do.” If manufacturers were able to model their designs virtually and iterate them hundreds of times to find the optimal design before building a physical sample, the time and energy saved could be enormous. “Other industries are using this technology; it’s been prevalent in cosmetics and food packaging for a long time. We have examples out there to pull from; it’s time we got started,” Burgess stresses. Industry developments aside, for Burgess the bottom line remains: packaging and sterility must be considered from the very outside of any medical device development process. “The best way to overcome the common challenges associated with this process, from material selection to supply chain issues, is to avoid them all together,” he concludes “And the only way to achieve this is through communication and upfront design characterisation work.” ●
Medical Device Developments /
www.nsmedicaldevices.com
Bojan Milinkov/
Shutterstock.com
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