Product packaging has increasingly become more important for companies in the last few years. With customers demanding for a better unboxing experience and the impact it has on brand awareness, it is no surprise as to why packaging is starting to take center stage. One of the industries where packaging is crucial is in the medical industry. Due to strict medical packaging requirements this key aspect of the product can severely affect product timelines if not planned efficiently.
This is because the packaging has to complement the product design, keep the product safe during transportation and while in storage but most importantly, it has to keep medical devices sterile.
While there are only a few sterilization methods, due to strict requirements and guidelines, it is critical for companies to understand how these processes work because the testing procedures can take up to six months to complete. If products fail any of these tests or are not sterile, you will have to start over again which can delay the whole process.
During this process, medical device packages are placed in an autoclave. Steam is then released into the autoclave after it’s been sealed. High pressure, heat and moisture are the elements that will put the packaging to the test. Making sure that materials are porous enough to allow the steam to flow through but protectant enough to now allow contamination is crucial.
Ethylene Oxide (ETO) Sterilization
Very similar to autoclave sterilization, the ETO process also places medical device packages into a vessel and seals them before introducing the gas. After the sterilization process has been completed, the gas is evacuated and the aeration procedure begins.
Since medical packages aren’t subject to high temperatures, most plastic materials are compatible with this method. On the other hand, the process can take up to several days depending on the aeration length.
The gamma sterilization process is extremely popular with single-use medical devices, with up to 40% of these devices opting for this method of sterilization. This procedure is also faster than steam or EOT gas sterilization since the packaging material does not have to be porous.
This is due to the fact that medical device packages are exposed to gamma rays from cobalt-60 which is a radiation source. The materials are not placed inside a vacuum sealed vessel, but are instead placed within thick concrete walls.
Electron Beam (E-Beam) Sterilization
Just like gamma sterilization, E-Beam sterilization destroys microorganisms at the cellular level by exposing the medical package to a beam of electrons. Additionally, while both methods rely on penetration to sterilize, the power is less in E-Beam sterilization. Making mid-to-low density materials ideal for this method.
Pioneer Can Handle Your Medical Packaging
Whether it is traditional plastic or sustainable materials, Pioneer Packaging has been engineering innovative medical packaging solutions. Pioneer Packaging meets the stringent requirements and standards set forth by the medical industry. Keeping your device safe, compliant, and on time. Contact us today to get started!