Self-Guided Control of a Fluid Bed Granulation Process

Better process understanding, drug product development, and manufacturing throughout the commercial lifecycle of drug products will lead to faster time-to-market and a more reliable, predictable supply chain (1). Adopting several of the tools and technologies which are part of the current Industry 4...

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Bibliographic Details
Published inPharmaceutical technology Europe Vol. 32; no. 1; pp. 32 - 35
Main Authors McCormack, Caroline, O'Callaghan, Chris, Clarke, Gareth, Jones, Ian, Kiernan, Luke, Walker, Gavin
Format Journal Article
LanguageEnglish
Published Monmouth Junction MultiMedia Healthcare Inc 01.01.2020
Subjects
Automation
Cloud computing
Controllers
Industry 4.0
Manufacturing
Moisture content
Particle size
Pharmaceutical industry
Process controls
Product development
Product quality
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Summary:Better process understanding, drug product development, and manufacturing throughout the commercial lifecycle of drug products will lead to faster time-to-market and a more reliable, predictable supply chain (1). Adopting several of the tools and technologies which are part of the current Industry 4.0 revolution (e.g., process analytical technology [PAT], big data analytics, manufacturing intelligence, in-process control, and cloud architecture) into everyday pharmaceutical product development and commercial manufacturing may provide an effective solution to many manufacturing quality challenges. In this case, information on the process design space and optimum control was derived from retrospective analysis of more than 160 batches run on the test-bed system (SmartX Innopharma Technology), while further detailed experimentation was performed to quantify the differences in end-product quality between the results of this advanced dynamic process control (ADPC) approach and the results using a traditional control approach. Endpoint moisture content of the fluid bed granulation process is critical to final product quality and process performance and must be tightly controlled to avoid issues with downstream processing, product dissolution, and stability as well as drug absorption rates in the body.
ISSN:1753-7967