Why medical-device packaging fails

If you’re a manufacturer of medical-device packaging equipment looking to build equipment that addresses the failures most commonly experienced by your targeted customer base, here’s a list:

Dec 31st, 2004

* Open tray and bag seals

* Blown holes

* Pin holes

* Abrasions

* Seals with leak paths

* Incomplete seals

These problem areas were identified by Carroll Councilman in her January 11 presentation at the Medical Design & Manufacturing Conference in Anaheim, CA. Councilman is the regulatory affairs manager for medical-device maker Avail Medical. Councilman went on to say that an analysis of the failures listed above revealed.

* Abnormally high or low temperatures during transportation or storage

* Unusual stress or shocks induced on the packaging during transit or handling

* Mishandling that could cause punctures

* Holes in the sterile barrier materials that occurred during packaging

* Improper sealing or closure of the package

* Inadequate validation testing

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