Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...
This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...
ANSI/ISA-106.00.01, Procedure Automation for Continuous Process Operations, has been published by ISA. The standard sets forth models, styles, strategies, philosophies, and life cycle for the ...
Anything that you do well is worth doing better over time. The term "continuous improvement" describes a process practiced by quality engineers but it speaks to something that every conscientious ...
Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...
The extent to which products meet specifications needs to be systematically monitored in a production process. Product quality will typically be defined by two quantities: deviations from stated ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...
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