Pharmaceutical Technology-05-15-2018

Pharmaceutical Technology

Impact of Agitator Design on Bioreactor Performance

May 15, 2018

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2018 eBook

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Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.

Characterizing a Bioprocess with Advanced Data Analytics

May 15, 2018

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2018 eBook

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Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.

Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish Requirements

May 15, 2018

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2018 eBook

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Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.

Can Standards Help Pharma Modernize Lyophilization?

May 15, 2018

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2018 eBook

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ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.

Residual Moisture Testing Methods for Lyophilized Drug Products

May 15, 2018

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2018 eBook

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Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Lies That Environmental Monitoring Systems Tell

May 15, 2018

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2018 eBook

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Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?