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Showing posts tagged with: QbD

Superior results and efficiencies achieved in food freeze drying

by gstrongitharm in BTL News, BTL Right Sidebar Content, Intelligent Freeze Drying, Uncategorized

Water is generally the main ‘ingredient’ in food and has a considerable impact on both physico-chemical and mechanical properties, which constantly change during storage [2,5]. The products shelf life is limited by the biological activity of microorganisms and water deeply affects it. Bacteria an...Read more

QbD: Building Robust Processes

by biopharma-admin in BTL News, BTL Right Sidebar Content

April 2015 Quality by design (QbD) for lyophilization is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, by minimizing risk and maximizing understanding of the process itself. Regulatory bodies such as the FDA r...Read more

A QbD Approach to Freeze Drying of Cytotoxic Compounds

by biopharma-admin in BTL News

February 2014 Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. This requires gaining an understanding of the product and each unit operation inv...Read more