无菌原料药分装时在线粒子爆表

砥砺前行n66

CCY1 发表于 2022-6-23 11:55
如果是分装时本身产生的粉尘引起的报警，那就是设置的位置不科学，重新评估换位置或者调整高度吧。

采样头加高是不是省事些，

栗子7

CCY1 发表于 2022-6-23 11:55
如果是分装时本身产生的粉尘引起的报警，那就是设置的位置不科学，重新评估换位置或者调整高度吧。

设置位置就是离关键点＜30CM，高度离操作台面在30CM左右，这个范围内但凡分装机开起来都会影响粒子计数。

螃蟹

无菌粉末分装过程中可以不监测，你可以参考评估一下：EU-GMP附录一无菌产品生产（2020年修订稿）
9.20.The selection of the monitoring system should take i n t o account any risk presented by the materials used    in the manufacturing operation (for example, those involving live organisms, powdery products or radiopharmaceuticals) that may give rise to biological or chemical hazards.
监测系统的选择应考虑到制造作业中使用的材料（例如，涉及活生物体、粉状产品或放射性药物的材料）可能引起生物或化学危害的任何风险。
9.21.In the case where contaminants are present due to the processes involved and would potentially damage the particle counter or present a hazard (e.g. live organisms, powdery products and radiation hazards), the frequency and strategy employed should be such as to assure the environmental classification both prior to and post exposure to the risk. An increase in viable particle monitoring should be considered to ensure comprehensive monitoring of the process. Additionally, monitoring should be performed during simulated operations. Such operations should be performed at appropriate intervals. The approach should be defined in the CCS.
在由于所涉及的过程而存在污染物的情况下，污染物可能会损坏颗粒计数器或造成危险（例如:活生物体、粉末状产品和辐射危害），所采用的频率和策略应确保在暴露于风险之前和之后进行环境分类。应考虑增加可行的粒子监测，以确保对该过程进行全面监测。此外，应在模拟操作期间进行监测。此类操作应在适当的时间间隔内进行。应在CCS中界定这一方法。

海二娃

采样位置不合理 不具有代表性，需要重新进行风险评估，然后再经过验证才行吧