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Sterile packaging is an essential factor in ensuring the safety and effectiveness of orthopedic devices. Seems obvious, right? It is. But packaging solutions aren’t always at the top of to-do lists for product development professionals. That could lead to significant delays in bringing new implants to market if defects are discovered during testing.
Complexities such as environmental and geometric sensitivities impact packaging design, underscoring the importance of addressing it from the start.
“It’s not one all-encompassing event before devices hit the market — it needs to be a piece of the overall manufacturing process,” said Wendy Mach, Senior Director of Technical Services at Canyon Labs. “You need to start thinking about packaging and sterilization when designing devices.”
Ethylene Oxide Alternatives
Increasingly, orthopedic manufacturers are moving away from ethylene oxide (EO) due to environmental and health concerns. “EO faces increasing restrictions on emissions, with the strictest guidance issued this year,” said Emily Lorcheim, PMP, Project Manager at ClorDiSys.
“These restrictions are causing lags in the supply chain and greater headaches for orthopedic manufacturers.”
A final rule released by EPA in March intends to reduce overall EO emissions from sterilization facilities by 90% and 21 tons per year. High-volume commercial sterilizers have two years to comply with the new directives.
Switching from EO to alternative sterilization methods comes with advantages and challenges, noted Johnny Kieu, Senior Packaging Engineer at Packaging Compliance Labs. One of the main benefits is reduced exposure to moisture, as EO cycles can reach up to 80% relative humidity, which may affect certain devices. Additionally, moving away from EO eliminates the dangers associated with its use, as it is a known carcinogen with short- and long-term health risks.
Kieu said shifting to a new sterilization method often requires changes in packaging design to maintain the integrity of the sterile barrier. For example, gamma irradiation can cause materials to discolor or become brittle, compromising the packaging’s sterility.
“A shift away from utilizing EO is no short feat,” Kieu said. “It requires identifying a compatible mode of sterilization and can include changing the packaging design if the sterile barrier requirements need to accommodate the new sterilization method.”
According to Kieu, understanding the material specifications of the device package is the first step in making the transition. Then, he said, identify the appropriate alternate sterilization method and the vendor with which to partner.
It’s important to involve contract sterilizers early in the packaging design process to ensure compatibility with sterilization methods. Lorcheim advises that packaging designers account for the specific requirements of each sterilization modality. For example, when using a gas or vapor method, the packaging must include gas-permeable materials to ensure effective penetration.
Conduct a thorough evaluation of material specifications before identifying an appropriate sterilization method and vendor, Kieu noted. He noted that some vendors process devices at the primary package level (Tyvek or film pouch), and added, “This would require a new process flow if the alternate sterilization method processes devices at the box level.”
Mach underscored the need for flexibility in packaging materials, especially considering that multiple sterilization cycles or exposure to high doses might affect the device and packaging integrity. “What will that do to the materials, not just the device, but the packaging?” she asked.
“That needs to be constantly considered.”
Designed for Aseptic Opening
Proper packaging not only preserves the sterile barrier, but also serves as a critical communication tool, providing product information and instructions for use to surgical teams. Ensuring that packaging can be easily and aseptically opened in the operating room is also a critical consideration for maintaining sterility at the point of use.
Lorcheim recommends conducting human factors testing involving surgical team members to determine the user-friendliness of a packaging’s design.
Ensuring that packaging is designed for easy, aseptic opening is a priority for maintaining sterility in surgical settings, as harmful bacteria in the operating room pose the risk of contaminating devices before implantation.
“Ultimately, performing a usability evaluation as prescribed by ISO 11607-1 will demonstrate the ability of a healthcare professional to aseptically open device packages in a sterile environment,” Kieu said. “This evaluation includes having surgical professionals assess the opening features on device packaging and note their ability to remove the product and then present it to the surgeon aseptically.”
Another key aspect of usability is ensuring that packaging labels are clear and legible, allowing surgical teams to quickly identify the correct device and digest its instructions for use, Kieu added.
“Feedback concerning the labeling of a device package has influenced our approach when we first begin designing labels,” he said. “Ensuring the printed words and numbers are legible will help to ensure members of the O.R. team can use devices quickly and accurately.”
Streamlined Designs
Mach highlighted the challenge of finding sustainable packaging solutions that do not compromise the sterile barrier. The shift toward alternative sterilization methods offers opportunities to develop more eco-friendly packaging, but she cautions that orthopedic companies must balance sustainability with maintaining product integrity and sterility.
“Sustainability is becoming more prevalent during new orthopedic device launches,” Kieu added. “This is a unique hurdle to navigate as packaging sustainability isn’t commonly practiced. There are no recycling pathways for opened packages or packages containing multiple material types.”
Kieu noted that many packaging systems are designed with what may be perceived as an excessive amount of material for the device it holds.
“However, these design features may be critical to ensure the integrity of the sterile barrier,” he said.
Looking ahead, packaging experts hope that closer collaboration between device designers and sterilization companies will address challenges like sustainability and will become more common in the product development process.
“I think more orthopedic manufacturers will begin consulting directly with sterilization companies before beginning packaging design,” Lorcheim said. “This will optimize sterilization, but also potentially reduce unnecessary costs or delays due to incompatible or excessive packaging.”
