相关实验视频
Updated: Jan 20, 2026

10:16
A Protocol for Real-time 3D Single Particle Tracking
Published on: January 3, 2018
15.3K
在机器人无手套隔离器中集成实时可行的生物光粒子计数器
Noel Long1, Manny Khera2, Bobby Lumia2
1Cytiva, Rhode Island, United States Noel.Long@cytiva.com.
PDA journal of pharmaceutical science and technology
|January 18, 2026
概括
先进的无菌处理使用机器人隔离器中的生物光粒子计数器 (BFPC) 实时环境监测. 这项技术提高了无菌性保证,克服了注射药物制造传统方法的局限性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 环境监测 环境监测
- 无菌性保证 无菌性保证
背景情况:
- 传统的环境监测方法难以跟上先进的无菌加工技术.
- 不断发展的监管指南,如欧盟附件1,建议隔离器技术和对GMP流程的持续监测.
- 生物光颗粒计数器 (BFPC) 提供实时检测可活和不可活颗粒,这与旧方法相比是一种进步.
研究的目的:
- 为了检查一个无手套机器人隔离器的设计,用于无菌填充完成操作.
- 评估BFPC的整合,以便在隔离器内持续监测环境.
- 评估隔离器空气流和粒子检测能力的有效性.
主要方法:
- 设计和实施一个机器人无手套隔离器.
- 使用计算流体动力学 (CFD) 和空气流可视化来研究隔离器性能.
- 在关键位置加入BFPC以实时监测颗粒.
- 进行干扰研究以描述BFPC在动态和静态条件下的性能.
主要成果:
- 机器人无手套隔离器设计有效地保护关键区域在皮过程中的污染.
- 隔离器内的堵塞过程没有产生可检测的颗粒.
- 在动态条件和物质转移过程中,BFPCs准确地检测到颗粒,没有错误的阳性.
- 隔离器内的空气流确保在无菌填充过程中保证无菌性.
结论:
- 机器人无手套隔离器与BFPC相结合,代表了无菌处理的重大进步.
- 这种综合方法增强了无菌性保证,并提供实时环境监测能力.
- 该技术解决了传统监控方法的局限性,并与现代监管期望保持一致.
相关概念视频
10:16A Protocol for Real-time 3D Single Particle Tracking
15.3K
This protocol details the construction and operation of a real-time 3D single particle tracking microscope capable of tracking nanoscale fluorescent probes at high diffusive speeds and low photon count...
15.3K
08:04Pancreatic Tissue Dissection to Isolate Viable Single Cells
3.8K
Pancreatic metaplastic cells are precursors of malignant cells that give rise to pancreatic tumors. However, isolating intact viable pancreatic cells is challenging. Here, we present an efficient method for pancreatic tissue dissociation. The cells can then be used for single-cell RNA sequencing (scRNA-seq) or for two- or three-dimensional co-culturing.
3.8K
08:59Measuring Sub-23 Nanometer Real Driving Particle Number Emissions Using the Portable DownToTen Sampling System
5.9K
Presented here is the DownToTen (DTT) portable emission measurement system to assess real driving automotive emissions of sub-23 nm...
5.9K
06:25A Real-Time Interactive System for Studying Confrontational Pursuit Behavior in Rodents
1.3K
Here, we present a protocol to detect and quantify predatory pursuit behavior in a mouse model. This platform provides a new research paradigm for studying the dynamics and neural mechanisms of predatory pursuit behavior in mice and will provide a standardized platform for studying pursuit behavior.
1.3K
10:12A Robotic Platform for High-throughput Protoplast Isolation and Transformation
14.9K
A high-throughput, automated, tobacco protoplast production and transformation methodology is described. The robotic system enables massively parallel gene expression and discovery in the model BY-2 system that should be translatable to non-model...
14.9K
The Integrated Rate Law: The Dependence of Concentration on Time
41.0K
While the differential rate law relates the rate and concentrations of reactants, a second form of rate law called the integrated rate law relates concentrations of reactants and time. Integrated rate laws can be used to determine the amount of reactant or product present after a period of time or to estimate the time required for a reaction to proceed to a certain extent. For example, an integrated rate law helps determine the length of time a radioactive material must be stored for its...
41.0K

