Search results for " monitoring"
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
…s, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control (4).
The control strategy may be a single document or a package o…
Article
The Lifecycle Change of Process Validation and Analytical Testing
…ification through the implementation of process analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding t…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…a pilot-plant environment, it has to find its way onto a historian or some other process control and monitoring system within the commercial or development laboratories where they're collecting all t…
Article
Use of Multivariate Data Analysis in Bioprocessing
Applications involving multivariate data analysis of these complex data sets to extract relevant information could be aimed at process monitoring in a manufacturing setting by detection of process fau…
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Leveraging Data for Better Biopharmaceutical Process Control
A great deal of work is needed to make advanced process monitoring and control approaches feasible.” At this point, due to higher complexity of unit operations and production infrastructures, biopharm…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This article presents the first part of a practical roadmap that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process valid…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Both, according to Cameau, offer more process control than flatware systems because bioreactors include sensors for monitoring of pH, dissolved oxygen (DO), carbon dioxide percentage, and other parame…
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Reliability Rooms and the Move to Proactive Supply Chain Management
…ce a revised process, simplified procedures, developed personnel training, and installed performance monitoring on the process. As a result, the company have seen a 35% reduction in issues, meaning m…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based ap…
Article
Bioburden Control in the Biopharmaceutical Industry
In-Process Monitoring and Quality Controls
The in-process control (IPC) monitoring of bioburden during the processing of non-sterile bulk product is crucial, especially during the upstream and dow…