Packaging isn’t always given the credit it deserves to protecting and preserving user safety. This is especially true in the realm of medical packaging, where the efficiency and durability of packaging can either preserve or corrupt essential medical tools. Beyond safety, medical packaging also affects storage efficiency, ease of use, and cleanliness.
If medical device manufacturers don’t consider these strict packaging needs at the beginning of their design process, they will endure delay after delay as they work to earn the many variations needed for medical device packaging approval. This quick introduction will walk you through the requirements for designing, sterilizing, testing, and validating a medical packaging project.
Package Design: Not Just a Whim
The majority of medical devices are packaged in a tray or a pouch. Pouches are perfect for companies whose main priorities are driving down material and equipment costs on a short timeline, but trays are more aesthetically pleasing and provide more protection to the items inside. If budget and time allow, trays are highly recommended.
Every product developed for medical purposes must be sterilized before being distributed to hospitals, clinics, and doctor offices. The most common sterilization methods include gamma, electron beam, ethylene oxide, an autoclave. Each has its own benefits, but overall it is critical that the sterilization method is capable of penetrating the product without breaking down the packaging or causing a change in color to the packaging. Gamma sterilization is most popular since it is typically fast and effective.
Meet Package Testing Requirements
Due to the important role that medical packaging plays, package validation tests are required to evaluate the seal integrity, material integrity, distribution, and aging of the packaging products. Some of these tests are time-intensive; the aging test can range from one to six months depending on the desired shelf life, so plan accordingly!
While it’s true that the medical tool or product itself gets the most attention for the role it plays in saving and improving human health, it wouldn’t be possible without strong, durable, and reliable packaging. To improve your own product packaging and avoid costly mistakes, call (781) 986-7500 to speak to a representative at Econocorp. One of our packaging sales representatives will help you find the information that you need to use the machine best suited for your medical packaging needs.