Knowledge Base
Sterile packaging and the burst test
It’s vital that patients in hospitals and other healthcare settings are protected from infections while receiving treatment.
To shield them from harm, all medical devices must be terminally sterilized after manufacture, then aseptically presented to the end user. In other words, the product and package must remain sterile from the moment it exits the sterilization process until the moment it’s used.
To offer confidence that a medical device won’t become contaminated through the supply chain, both product and the protective packaging should form a single functional entity – a sterile barrier system operating to keep contamination at bay.
The burst limit test will help to qualify your manufacturing process as part of a carefully considered and designed package testing program. Burst testing validates the integrity of your sealed packages, indicating how they will react when faced with supply chain conditions. It offers assurance that the weakest areas will hold up against during sterilization, normal handling, transportation, and storage.
A burst test for all medical packaging types
Medical packaging comes in different forms, depending on the products contained.
Porous materials like paper and cardboard provide a biological and environmental barrier, but allow enough air flow to enable terminal sterilization. Using gasses like ethylene oxide (EO), ozone, mixed oxides of nitrogen, and chlorine dioxide.
Then there are non-porous packages like metal foils or plastic films, which don’t have pores or small openings to allow volumetric air flow.
The good news is that the burst test works on both types of medical packaging. The results that you obtain through the burst pressure test tell you about the entire package. It’s a destructive test that shows you the minimum seal strength and the weakest seal area. Plus, it’s equally applicable to peelable and non-peelable seals.
Burst testing is just one of the ways you can prove the sterile barrier system (SBS) of the packages you use. At Industrial Physics, we help medical device manufacturers test each and every critical parameter required to ensure the integrity and compliance of your medical device packaging.
Contact us today, or click here to learn more about the many accurate and reliable burst testing and medical packaging inspection devices we make.
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