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- W2183071309 abstract "The pharmaceutical industry have long been crippled by the restrictions on the production routes. This have made production expensive without assuring a good end result. To make pharmaceutical production more flexible new guidelines have been developed. With the new guidelines pharmaceuticals can be produced as long as the critical process parameters are within the Design space. The Design space consists of the combinations of critical process parameters and process inputs which results in critical quality attributes reaching their minimum values. To find the design space several different methods have been developed and evaluated. The methods work very well but visualizing the design space becomes harder and harder as the dimension increases. The optimal design space was created to make the design space easier to grasp and to take the process economy into account. When finding the optimal design space the problem was reduced to an optimization problem were the economical parameters (yield and productivity) were maximized. The critical process parameters could then be expressed as a function of yield and load resulting in an optimal design space which only contains the optimal way of running the process and is easy to visualize. Variations are always present in all processes and this should also be considered when creating the design space and thus a robust optimal design space would be ideal but by adding process variation the optimization problem gets harder and local minima can occur." @default.
- W2183071309 created "2016-06-24" @default.
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- W2183071309 date "2013-01-01" @default.
- W2183071309 modified "2023-09-27" @default.
- W2183071309 title "Design Space in pharmaceutical industry" @default.
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