非最终灭菌工艺灌装区需要实时环境监测吗

被吹散的婆婆丁

如题，有没有法规要求对非最终灭菌工艺的B+A区进行实时环境监测？
如果生产过程中，实时监测显示超标了出现偏差，那么这批产品是否可以放行？

扬帆闯荡

按照GMP附录1无菌药品第十条
第十条 应当按以下要求对洁净区的悬浮粒子进行动态监测：
（一）根据洁净度级别和空气净化系统确认的结果及风险评估，确定取样点的位置并进行日常动态监控。
（二）在关键操作的全过程中，包括设备组装操作，应当对A级洁净区进行悬浮粒子监测。生产过程中的污染（如活生物、放射危害）可能损坏尘埃粒子计数器时，应当在设备调试操作和模拟操作期间进行测试。A级洁净区监测的频率及取样量，应能及时发现所有人为干预、偶发事件及任何系统的损坏。灌装或分装时，由于产品本身产生粒子或液滴，允许灌装点≥5.0μm的悬浮粒子出现不符合标准的情况。

个人理解。及时发现所有人为干预、偶发事件及任何系统的损坏，B+A区域至少在产品生产的全过程应该进行监控。避免检查老师找你麻烦。

余默

老师你指的是悬浮粒子还是微生物

LSINDER

要实时监测吧，GMP要求的

Keves

个人理解是只要求对灌装机内部环境进行实时监测，背景房间没有提到强制要求的，

lzq050628

欧盟无菌附录讲的很清晰
9. For Grade A zones, particle monitoring should be undertaken for the full duration of critical
processing, including equipment assembly, except where justified by contaminants in the
process that would damage the particle counter or present a hazard, e.g. live organisms and
radiological hazards. In such cases monitoring during routine equipment set up operations
should be undertaken prior to exposure to the risk. Monitoring during simulated operations
should also be performed. The Grade A zone should be monitored at such a frequency and
with suitable sample size that all interventions, transient events and any system deterioration
would be captured and alarms triggered if alert limits are exceeded. It is accepted that it may
not always be possible to demonstrate low levels of~5.0μm particles at the point of fill when
filling is in progress, due to the generation of particles or droplets from the product itself.
10. It is recommended that a similar system be used for Grade B zones although the sample
frequency may be decreased. The importance of the particle monitoring system should be
determined by the effectiveness of the segregation between the adjacent Grade A and B
zones.The Grade B zone should be monitored at such a frequency and with suitable sample
size that changes in levels of contamination and any system deterioration would be captured
and alarms triggered if alert limits are exceeded.

猫咪特工

要实时检测

稻草人°93

整个灌装全过程都需要监测

来自苹果APP客户端

被吹散的婆婆丁

现在灌装机A级区内肯定有实时监控。但是B级背景需要进行监控吗？以及监控点选定要求？太靠近人容易出问题，出偏差

sjx518

整个灌装全过程都需要监测