Regulatory issues for radiation sterilization centres

A sterilization centre must understand its processes and describe them in a high quality manual. At present, the processes and procedures need to comply with ISO 11137:1995 or EN 552. In the future, they will need to comply with ISO 11137:2006, which may require changes to the processes, nomenclature and procedures employed. Training may then be required to update all workers. According to ISO 11137:2006, only certain elements of the QM system of the sterilization centre must comply with ISO 13485; however, clients and national or local regulations may force the centre to comply with it completely. The most important requirement for the sterilization centre is to have its process under control. This means that process parameters must be carefully established, monitored and controlled. Deviations must lead to cause and effect analyses, and non-conformities must lead to corrective actions. All this is only possible if the measurements are performed with the best precision and accuracy attainable. For this reason, all measurement systems and instrumentation must be calibrated with traceability to national or international standards. The sterilization centre has to fulfil its responsibilities towards applying a validated irradiation process to the product to be sterilized. The facility and product must be characterized. IQ and OQ define and validate how the facility's irradiation process will be applied. During PQ, the product specific procedures are specified and validated. Provided that all requirements are met, the sterilization centre can certify the correct application of the irradiation process, typically including the applied minimum and maximum doses which have been calculated based on product specification, dose mapping in relation to process parameters, and dose measurements at routine monitoring positions