Validation FAQ Regarding PST® Corp's Plastic Sterilization Trays
The trays manufactured by PST® are intended to be used with an over wrap or placed into a sterilization container with filters or valves for the intent purpose of sterilizing the contents and maintaining sterility. It is not possible for a manufacturer of instrument trays to make claims about sterility when the eventual contents are not known. Moreover, it is not possible for instrument trays to maintain sterility of the contents because they are not manufactured for the purpose of providing a barrier for a sterile environment. That is why they must be used with over wraps or placed in a closed sterilization container that maintains sterility.
The end user is best suited to assess the efficacy of the sterilization process by utilizing current standards and load assessment and to develop procedures for establishing efficacy and shelf life standards. It is not possible for us to know, or instruct, as to what the contents or eventual use of the tray will be.
Testing can only be done once all of the intended components are identified and all of the contents are brought together and assembled. The testing need be accomplished with an over wrap or sterilization container for the intended purpose of sterilizing the contents. The end user normally develops procedures and standards to accomplish this. Certain biological and chemical parameters are used to validate the process as directed by internal standards and procedures at the end-user’s facility. The manufacturer has no control over these functions.
* PST® is a registered mark of PST Corp