ABSTRACT
The medical device industry is using contract sterilization at an increasing rate. A contractual relationship must exist between the manufacturer and the sterilization contractor in order to guarantee a well-controlled sterilization process capable of producing a sterile, safe, and effective product. A direct impact of the trend is a downsizing of the sterilization support and technical knowledge within the medical device manufacturer's staff. Even before the sterilization facility is chosen, a decision must be made as to what will be the most appropriate sterilization method. Validation of the sterilizing dose is the responsibility of the device manufacturer, but responsibility for the validation tasks may be delegated to individuals employed by the contractor. Contract sterilizers are considered an extension of the device manufacturer's operation and are responsible for the manufacturing operations that they perform. On receipt of the routine batch information from the contractor, the manufacturer should review the processing documentation to ensure that the validated specifications were met.
