关于培养基模拟灌装试验装配过程尘埃粒子监控问题？

qq540202

     请问下大家在培养基模拟灌装试验中灌装岗位在进行装配灌针时灌装机的尘埃粒子在线监测发生超标报警（刚好尘埃粒子采样口在装灌针位置附近），请问下有没有要求灌装过程对尘埃粒子的要求或者是否需要进行监控？那么大家有什么好的建议解决在装配过程中尘埃粒子超标呢？

ALPACA

装机操作也算是一种干扰动作，在模拟灌装中应当挑战，有干扰操作时，粒子是可能会超标的，可以备注说明

wsx

假如你在装配过程，粒子都符合规定，说明你的数据是假的。或者说你的在线监控系统有问题。

qq540202

wsx 发表于 2021-4-15 13:10
假如你在装配过程，粒子都符合规定，说明你的数据是假的。或者说你的在线监控系统有问题。

那么超标也说明有问题啊。意思是在装配过程中粒子超标不用管么？

qq540202

ALPACA 发表于 2021-4-15 12:51
装机操作也算是一种干扰动作，在模拟灌装中应当挑战，有干扰操作时，粒子是可能会超标的，可以备注说明

只需要在备注说明就行了么？其他不用管，比如：对超标次数的管理？

椒陵小小兵

wsx 发表于 2021-4-15 13:10
假如你在装配过程，粒子都符合规定，说明你的数据是假的。或者说你的在线监控系统有问题。

扯淡，我们的装备就不会有这样的问题

ALPACA

qq540202 发表于 2021-4-15 13:14
只需要在备注说明就行了么？其他不用管，比如：对超标次数的管理？

不用，装机时做好微生物监测，模拟灌装挑战最长时间和最多干扰次数

qq540202

ALPACA 发表于 2021-4-15 13:26
不用，装机时做好微生物监测，模拟灌装挑战最长时间和最多干扰次数

干扰的前提是粒子符合要求得嘛，对超标进行次数最长次数规定或验证？

wsx

椒陵小小兵 发表于 2021-4-15 13:22
扯淡，我们的装备就不会有这样的问题

高，能指导一下怎么做到不干扰的吗？

椒陵小小兵

wsx 发表于 2021-4-15 14:43
高，能指导一下怎么做到不干扰的吗？

就是无菌操作的规范性问题，我还真没听说过装设备的时候粒子超标属于正常的

CCY1

装机也是需要监控粒子和埔碟子的，跟生产没区别。

光风霁月

以下信息希望对你有帮助：
PDA (2011) TR22 Process Simulation for Aseptically Filled Products (可在论坛找到)

6.0 Microbial Environmental Monitoring
It is important to determine and understand the environmental conditions present during the process simulation study.
The elements and process that define and detail the establishment and maintenance of an effective environmental monitoring program can be found in PDA TR 13 Fundamentals of a Microbiological Program.

Process simulation should be carried using the routine environmental monitoring operating procedures and sampling requirements.
The results of the environmental and personnel monitoring are used to assess whether suitable processing conditions were maintained during the process simulation. Additionally, environmental and personnel monitoring results obtained during process simulation can aid in the identification of root cause if the process simulation yields any positives.


PIC/S (2011) Guide PI007-6 Recommendation on the Validation of Aseptic Processes （可在论坛找到）
7. Environmental and Personnel Monitoring
7.1 Air Borne Microbial and Non-Viable Particle Monitoring
7.1.1 Worst case scenarios of simulations test should also include monitoring activities.
7.2 Non-viable Monitoring
7.2.1 For the filling environment the counts should be performed adjacent to the filling zone and where components are exposed in such way as to detect operator activity within these areas.
7.3 Microbial Monitoring
7.3.1 It is usually expected that a combination of the methods identified in the Annex 1 0f the EU/PIC/S GMP guide for monitoring microbial levels is used in environmental monitoring programmes where appropriate.
7.3.2 Microbial monitoring should be performed in and around areas of high operator activity.
7.3.3 The process simulation test provides an ideal opportunity to confirm that worst case locations have been identified by use of additional monitoring during the test.
7.3.4 A useful monitoring techniques is to monitor the filling needles at the end of the filling session.
7.3.5 Additional monitoring around the affected area prior to disinfection may provide useful information as to the cause.
7.4 Intervention Monitoring
7.4.1 It is essential to include in a simulation test the various interventions that are known to occur during normal production runs.
7.4.2 The process simulation test should last long enough to accommodate all possible interventions and a "worst case scenario", which may include several unfavourable conditions which are occuring during routine processing.

Aseptic and Sterile Processing Control, Compliance and Future Trends (并不是法律法规指南，论坛没有该资源)
中文翻译本-培养基灌装章节中关于环境和人员监控
在工艺模拟过程中，从微生物角度对生产环境状态进行评估不仅是必须的也是明智的。微生物（和微粒）环境监测能够提供环境对工艺模拟产生影响的有用信息。
培养基灌装期间环境监测的程度应考虑两种不同需求。一方面，应依据工艺模拟获得尽可能多有关过程的信息和知识。另一方面，培养基灌装应尽可能模拟实际过程。应根据过程和相关风险分析在两种逻辑之间寻求合理的平衡。然而，培养基灌装期间的环境（和人员）监测通常不能低于生产期间的要求。

wsx

CCY1 发表于 2021-4-15 16:18
装机也是需要监控粒子和埔碟子的，跟生产没区别。

你们装机过程粒子都在范围内吗？

CCY1

wsx 发表于 2021-4-16 08:21
你们装机过程粒子都在范围内吗？

偶尔会有超标的，自净后可以恢复就没问题，通过视频监控也能判断是否人为干扰导致。

小金库

非常感谢分享