Your project team has come to the critical stage where you need to consider how you will package, sterilize, and ship your product. How do you ensure your medical device arrives safely at the various medical facilities, hospitals, and clinics? With so many packaging options, how do you find the perfect sterile barrier system for your product? In my role at Oliver Healthcare Packaging, I am often the first person a new customer works with. Here is how I get them started.
The choice of medical packaging is not a simple one and there are a variety of important features that must be incorporated into the packaging. To ensure the integrity of your packaging, you must first consider the following: What are you packaging? By asking this question right out of the gate, we can immediately evaluate the type of packaging that would be suitable. For instance, if the product is an implant, a biologic, or a pharmaceutical, a pouch might be recommended. If the product is large or heavy, we may suggest a lid for an existing tray, or an HDPE stabilizing card. Catheters will likely utilize a clipless dispenser for both safety and ease of use in an operating theater. Knowing a customer’s product helps determine which category of packaging they will likely need.
Next, I need to ask what size is your product? Packaging that is too small or too large can lead to a breach in the sterile barrier, which is often discovered in transportation testing. Knowing this information, we move on to material choice and durability. When deciding on material type, questions often follow a similar pattern, including: Is the product sharp or does it have any sharp or rough edges? If so, a puncture-resistant material is necessary to avoid breaching the sterile barrier via pinhole or abrasion.
What type of sterilization modality will you be using? Material choice is dependent upon the type of sterilization and whether the material can withstand the chosen sterilization. For example, does the package need protection from moisture, light, or chemical exposure? To this point, will temperature fluctuation matter? Lastly, there are questions that are specific to the type of packaging being produced. For example, if the packaging is a pouch, what type of opening is desired to ensure aseptic transfer? Peelable or tear notch? For lidding and or roll stock applications, what will it be sealed to?
Packaging & design experts around the world will tell you that ample attention to detail should be used in creating medical packaging … just as it is with the medical device. Knowing the right questions to ask in the beginning can make all the difference in the ease and direction of your packaging development.