The standards for manufacturing medical devices are rigid and must follow FDA guidelines closely. The same can be said for the containers, pouches and cartons that the devices are sterilized and transported in. For every size and shape of packaging material, there is a specific standard that must be documented via testing before the packaging is considered safe for use.
Burst testing is used to test the strength of a seal that has been attached to a container by one of several adhesives used in the industry. Using a specialized machine, air is blown into the container by way of a puncture in the lid. When the container has reached the threshold of how much air it can hold, it bursts. The machine produces a value which is then compared to the standards it must meet to satisfy quality assurance guidelines. This type of packaging testing is common with plastic containers with a peel-back lid.
Peel testing is utilized with products that require Tyvek or plastic pouches. A section of the seal of an empty pouch is cut and spread forming an upper and lower flap. These flaps are secured to a machine that pulls the sections in opposite directions until they separate. The reading given by the machine is the measurement of how strong the seal is. The value is then compared to the standards that must be met.
Dye testing is perhaps the most versatile type of testing for medical packaging. It is used with all types of packaging that have seals. The process of dye testing involves injecting colored dye into an empty, sealed container or pouch. The person performing the test verifies visually that the dye cannot penetrate the seal of the packaging. There are no measurements to record. The goal is to simply confirm the seal is airtight. The use of these testing methods ensures products will arrive at their end destination clean and ready to be implanted.