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…

Understanding FLASH and the Change in Terminology

By kschlachter

Understanding FLASH per the CMS 2014 document. In a memorandum from the Center for Clinical Standards and Quality/Survey & Certification Group on August 29, 2014, CMS outlined the changes in terminology with Flash sterilization and…