As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. Even if manufacturers opt for a proven packaging configuration, it needs to ensure physical protection, maintain sterility up to the point of use, provide proper documentation and allow hygienic presentation. The device components and the packaging system must provide a sterile medical device that performs efficiently, safely and effectively in the hands of the user.
Finding a compatible packaging configuration for your device plays a significant role in final delivery and performance. If you can stay ahead of potential packaging pitfalls, you may be able to support the delivery of an intact, sterile final product.
“Manufacturers need to build the packaging around the device rather than just put the device in a package that exists and hope it works,” says Britt Jones, chemistry and package testing manager at WuXi AppTec. “If end-users examine the package and see that it’s wrinkled, torn and is just messy, they may not favor that supplier as much.”
The packaging system design and choice of materials are influenced by the specific nature of the medical device, the planned sterilization methods, the intended use, expiration date, transport and storage, according to ISO 11607. Avoiding these 3 packaging pitfalls can help ensure your end-user receives a device that is fully functional and presentable.
Compromised Sterile Barriers
Above all else, a product’s sterile barrier must remain intact from the moment of initial packaging until the device’s first use. If a device’s sterile barrier is compromised, there is no way to prove the contents are sterile which, at worst, puts end-users at risk and, at best, leads to discarding perfectly usable devices.
There are myriad ways packaging choices might contribute to compromised sterile barriers. For example, packaging pouches that use foil or Tyvek poly on one side and paper on the other are popular but may not be compatible with all devices. Heavy or irregularly shaped devices can easily compromise the seal or poke through the pouch, leading to issues with packaging integrity.
Heat-sealed poly pouches can also face sterility problems, such as the folds or channels in a poly packaging pouch creating pathways for bacteria. Similarly, heat-sealed pouches with large openings can be fully sealed in one area but compromised in another. A medical device testing partner will detect packaging vulnerability with bubble emission testing or a dye penetration test, so it is good idea to have them validate your heat sealer.
Transportation and storage methods can also impact packaging choices and cost, but those decisions are usually made case by case.
“All the packages are going to require drop testing, compression testing and vibration testing,” Jones says. “But, depending on its destination, non-porous packages may go through aircraft simulation because they can swell and burst in low pressure, high altitude environments. That could cause an issue with the sterile barrier.”
Unusable or Illegible Packaging
Choosing the right configuration and ensuring sterility are paramount to medical device packaging success, but the product’s usability upon arrival to the end-user is equally important.
The US FDA says labels must be designed and applied to devices and containers well enough that they will remain in place and legible during the “customary conditions of distribution, storage and use.” User instructions and other labeling needs to remain legible during routine storage and use. The US FDA guidelines are clear that the onus for ensuring label printing is legible, and will remain so until the device is used, falls squarely on the manufacturers.
A package testing partner can conduct simulated distribution testing, which will expose labels to conditions that will help predict if they will rub off or become illegible. They can also conduct seal testing to ensure the seal holds up under normal conditions and that end-users won’t struggle to open the packaging once the product arrives.
While usability of the packaging is critical, some of the most common questions Jones receives from manufacturers focus on aesthetics. He says they are often concerned about what the packaging is going to look like after distribution or after a significant duration on the shelf.
“If it’s a wrinkled, damaged pouch or an illegible label that’s coming off, then that’s an issue,” Jones says. “The clinicians want it to look aesthetically pleasing and they often give feedback around that.”
Common supermarket behavior illustrates how quickly the average person makes a snap judgment about a product based on its appearance on the shelf. With health care professionals and eventually consumers, it is no different.
Too Much or Too Little Packaging
How much packaging a device needs is essential to consider even before a packaging partner gets involved. Some manufacturers will use single-package configurations across multiple products because they are readily available. Aggressive go-to-market timelines may also entice a company to opt for these materials.
While it may be more efficient at the time, this approach can lead to increased risk. Overly conservative estimates on the amount of bubble wrap, layers of cardboard or number of barriers needed can put the device in jeopardy. Likewise, opening an overly packaged device is not cost-effective. It could also require a sharp object, which creates room for user error that could leave the device broken or sterility compromised.
To ensure you are providing a sterile, safe, user-friendly product to end users, it is crucial to work with a package testing partner you trust. Obtaining test data will help device manufacturers predict outcomes that will save time and money, and ensure their product is sterile and usable when it gets to market.
“You’ve got to do the testing so you’re not spending too much money on packaging on the front end, but you are using enough packaging to ensure sterility on the back end,” Jones says.
Protecting Patient Safety
Choosing the right packaging configuration for your medical device may be complex, but it is critical. Materials, enclosures, usability and presentation all contribute to device integrity and overall patient safety and, as such, cannot be ignored. Enlisting the help of a medical device packaging partner can save you from selecting a less than ideal configuration, and their partnership can help ensure a safe, usable device is delivered to your customers.
For more on the evaluations used to gauge the efficacy of product packaging, please see our services page.
To stay up to date on the latest industry news and regulatory changes, follow us on LinkedIn.
For early access and exclusive content sent straight to your inbox, subscribe today to our premium content.
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,400 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”
