YHMOSSP111A辐照灭菌过程控制规范

sterilization dose is established, in the continuous production phase of theРРproduct, the Quality and Law Department shall organize representative products to be dosed every 3 months for a dose audit. The frequency reduction can be as low as half aРРyear, but at least once a year. In the discontinuous production stage of the product, theРРquality regulations department is responsible for completing the dose audit before producing the formal product. The dose audit shall complete the bioburden test, dose testРРand sterility test in accordance with the requirements of ISO 11137-2. If the dose audit is successful, the sterilization dose will continue to be effectiveРР?产品族的保持?Product family retentionРР质量法规部每年应对产品族进行审查，以确保产品族和代表产品族的产品持续有效。РР生产过程中，应对生产条件、生产工艺发生改变的产品及新产品应进行初始污染检测，确РР保代表产品的持续有效。