Through the many years I’ve spent in this industry, I’ve seen the trend of double vs. single sterile barrier go in waves. It’s part of what made me so interested to dig into creating a series about this. As we spoke with industry experts across various portions of the healthcare packaging value chain, it made me want to share my thoughts and experience on the topic—through the perspective of packaging design. My hope in writing this is to share my knowledge and expertise to help you make a more informed decision next time you are debating between a single or double sterile barrier system, as well as to foster conversation around this topic in industry.
Often times, in my opinion, single vs. double sterile barrier is influenced by what competitors in the MDMs space are doing. Many times, a competitor will come in looking for a package design similar to the current market leading device—without considering if the packaging is good or bad. Which means they come with a preconceived notion on whether they want a single or double sterile barrier. When this happens, a customer’s want of course plays into the overall design.
When designing for single or double pouching you must take certain challenges into account. The number one consideration when my team is designing a pouch is movement. The more shifting, the heavier the device, the higher the risk of damage to the sterile barrier. In the case of adding an outer pouch to a packaging system, even when properly fit, means there is more room in the shelf carton for the pouches and device to move. Extra movement can also create a higher propensity for seal issues, like seal creep. Therefore, how a device shifts within a packaging system will always be a concern and consideration.
Another design consideration I always think about with any packaging system, but particularly with double sterile barrier systems are the materials being used. It becomes more than just design but also looking at how the materials will interact together. Sometimes we get requests for a double sterile barrier due to a failure that has occurred in testing and as a result the customer is looking for added protection. But a double sterile barrier does not automatically equal a safer package. In fact, say you are using a 48ga polyester based film and are looking to use a double pouch system for extra protection. The added layer could easily be negated by the extra room and movement that is needed to accommodate the extra barrier. Usually, this is more evident in heavier devices or devices with a particularly high profile. It’s important to stress that selecting the right fit and materials can easily solve the issue and mitigate failures. Often, we see the wrong materials and size being used, which is typically when customers then turn to double pouching as a solution.
At the end of the day, when it comes to single vs. double sterile barrier systems, I’d don’t think there is a right or wrong. But, in my opinion, a properly fitted single sterile barrier system combined with appropriate material selection, is more important than going with a double sterile barrier system out of the concern of passing testing. Every medical device’s path to market is unique so it’s crucial to look at each one individually and weigh the pros and cons before deciding what direction to proceed.