Guidelines for Validation of the Lyophilization Process

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Guidelines for Validation of the Lyophilization Process
Institute of Validation Technology
Code: 40-001
Price: $19.35
Journal of Validation Technology Vol. 3, No. 4 This paper considers the key steps in the validation of the lyophilization process which are the freezing process, primary drying and secondary drying. The main emphasis of the paper is to show the importance of establishing a window of parameter values for each of these processes. The establishment of the window is illustrated by an example of the lyophilization of a hypothetical formulation.