What is Package Integrity Testing?

2020-09-10T12:18:17+00:00Categories: Contract Manufacturing|

Package integrity testing is used for shelf life studies and for looking at packages which hold sterile products that need to remain sterile and free from defects of any kind.

Packaging of materials that need to be sterilized and remain in a sterile condition for a predetermined shelf life must undergo package integrity testing. This allows the package to be tested at intervals during the proposed maximum shelf life, to prove that the packaging is still providing an effective seal and protection for its’ contents, from environmental influences.

Accelerated aging studies are an important part of the package integrity testing process. Accelerated aging allows the simulation of aging, in which the package is placed into an incubation chamber, at a temperature higher than room temperature. Higher temperatures in the incubation chamber allow for the process of aging a package much faster than room temperature aging. Shelf life can be validated through this procedure. Using accelerated aging in conjunction with package integrity tests allows the manufacturer to know that their packaging will have the same strength and provide the same sterile barrier that it did initially.

Another advantage of accelerated aging is that studies on aged packaging can be performed much faster because a wait time of 3 years is not necessary, when using accelerated aging. Years of shelf life aging can be reduced to months by using the accelerated aging process.

Some tests that C.G. Labs offers to asses package integrity are:

Burst

Involves filling the package with compressed air until burst point, the pressure at which the package bursts are measured, recorded, and reported. This is a quantitative test; the burst pressure is recorded in inches of H2O.

Dye Penetration

Specific dye is injected into an unopened package, where each seal is tested for channels and breaks in the seal. This will show any obvious seal malfunctions and or holes in the seal. This is a qualitative test; any leaks are seen visually.

Peel Testing

Portions of the package seal are cut out and places in a device that measured the strength used to completely peel one side of the seal from the other. This is a quantitative test; it will give you an accurate strength of the seal.

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