Package Strength Testing | Medical Device Packaging
Common standards associated with package strength include: ASTM D3330, ASTM F88 and ASTM F1140
In order to produce acceptable packaging on a daily basis and throughout a determined shelf life validation, it is important to evaluate the strength characteristic. Not only does strength play a key role in a shelf life package validation, but it also lets the medical device manufacturer determine that their process for sealing packages is staying consistent to their predetermined specification set in the process validation.
There seems to be some confusion within the medical device industry regarding the strength of a package as opposed to the integrity of a package. Package strength concerns the force required to separate two components of the package. It could be the force to separate two flexible components of a pouch, or a flexible lid and a thermoform tray. These forces may be measured in pounds per inch width, as in the seal/peel test; or in pounds per square inch, as in the burst test method. Alone, these tests of package strength values do not necessarily prove the integrity of the entire package. In fact, the seal width that was actually measured may be within the strength specification but may have a channel leak that could breach the package and negate integrity.
The main culprit for poor package strength is the sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure. |
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Some typical package strength testing services include ASTM standards such as:
| ASTM D3330 |
Package Strength Testing by Peel Adhesion Testing |
| ASTM F88 |
Package Strength Testing by Seal Peel Testing |
| ASTM F1140 |
Package Strength Testing by Burst Testing |
Have a question? Please contact us or Ask our Package Testing Expert about your next package strength testing project.
You can also call us at 1-800-229-4235.
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