A Brief Guide To Packaging For Medical Devices –

One of the very first things that should be considered during the development process of a new medical device is the type of packaging that it comes in and the material(s) used. As part of this process, the weight and size of the device need to be taken into account, as well as sterilization methodology, and the number of sterile barriers that there are (e.g. double barrier or single barrier). By establishing exactly what the requirements are in relation to these points early on in the process of designing the packaging allows for the possibility of feasibility studies to be undertaken.

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Testing the packaging –

Before any medical grade packaging can be approved, it must first be shown to be capable of being able to withstand the transit life cycle that it will likely face. In order to determine if it has the required capability, distribution of test devices is performed with worst case scenario conditions present so that all facets of the packaging are fully tested.

The intensity of this testing is determined by what the medical device is. The expected transit life of packaging for medical devices includes handling, processing, sterilization, warehousing, and transit. The final piece of testing that is done after distribution works to prove the integrity and strength of the packaging.

In addition to this, it is a requirement for aging studies to be performed so that the packaging can receive all of the required regulatory approvals. These prove that the packaging will remain fully intact even at the very end of its shelf life. As part of these studies, the integrity and strength of the packaging must be verified after a number of specified time points. Whilst accelerated aging tests can be performed for the purpose of regulation submission, real aging samples need to be run in parallel to this.

Strength Testing –

This is done in order to determine what level of force is required in order to make any two pieces of the barrier system to come apart. The reason why it is important to determine packaging strength is because it demonstrates if it is robust enough to contain the medical device, even after the aging process. Testing the strength of the seal on the packaging provides confidence to the manufacturer of the medical device that it can be used for the purpose of distribution without the contents being compromised. 

Integrity Testing –

This is done to determine exactly what the shelf life of the packaging, as well as to determine the sterility of it also. The process involved checking it for any punctures, or channels / paths through that contaminants may have in reaching the medical device that is inside. This is predominantly done through visually inspecting the packaging. The same visual inspection is also done to the seal as well.

When these two types of testing are performed together, they give clear evidence regarding both quantitative and qualitative factors that the packaging is appropriate and robust enough to contain a medical device, and will not negatively impact on its integrity. 

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