ONE TRAY® Extended Shelf Life Testing

By kschlachter

ONE TRAY® was cleared in 2006 by the FDA with a validated 48-hour storage period following steam sterilization on a 4-minute prevacuum cycle at 270 degrees with no dry time required.  The FDA has acknowledged that the product was cleared with this storage period within which processed devices should be used. Innovative Sterilization has conducted…