Search results for " process monitoring"
Article
Remote Monitoring and Big Data Advance Upstream Automation
Demers, meanwhile, sees PAT such as Raman spectroscopy being used for not just process monitoring, but bioprocess control and automation. “Longer term there will be sufficient established PAT solution…
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
QbD and PAT in Upstream and Downstream Processing
This can either transmit out for a PAT approach, or can allow for well-designed process monitoring.
QBD AND PAT IN BIOPROCESSING
BioPharm: What are some recent advances in PAT or other…
Article
The Lifecycle Change of Process Validation and Analytical Testing
Typically, this included a smaller number of discrete pieces of data, significantly less than that generated by continuous process monitoring as part of the lifecycle approach.
The identifi…
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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
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Understanding Validation and Technical Transfer, Part 3
During the implementation and commercial manufacturing phases, engineering designs are finalized, equipment is qualified, processes validation studies are finalized, and ultimately continuous process …
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…