Posts Tagged ‘process development’
A QbD Approach to Freeze Drying
April 2013
Quality by Design (QbD) is a systematic approach to development that begins with the defined objectives and emphasizes science and quality risk management in order to achieve those goals. QbD ensures that the quality of the product is …
Read MoreThe Importance of Endpoint Determination to Freeze Drying Success
In freeze drying there are two key endpoints to consider: primary drying, in order to know when to advance into secondary drying, and the end of the overall process.
Where primary drying should end and secondary drying begin is not …
Read MoreThe Importance of Critical Temperatures in the Freeze Drying of Pharmaceutical Products
Every formulation has a critical temperature, below which it should be cooled for complete solidification and maintained below during primary drying in order to prevent processing defects. To design a freeze drying cycle on a rational basis such information should …
Read More‘SMART’ Freeze Drying
By removing the ‘trial-and-error’ element from developing lyophilisation processes, a new technology enables users to optimise lyophilisation cycles and ensure the smooth transfer from laboratory- to production-scale.
Major challenges in lyophilisation are the development of an optimised lyophilisation cycle, and …
Read MoreLyostat Speeds Process Development at Danisco
Danisco is a world leader in food ingredients, enzymes and bio-based solutions. Their ingredients are used worldwide in a range of industries from food and drink, animal feed, chemicals and biofuels.
Danisco received their Lyostat freeze drying microscope last year …
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