* 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
