Biopharmaceutical Processing by unknow

Author:unknow
Language: eng
Format: epub
ISBN: 9780128125526
Publisher: Elsevier Ltd.
Published: 2017-11-21T16:00:00+00:00

Design Space

The concept of the design space is based on identification of process parameters and their subsequent classification into those: (1) affecting the product CQAs, the so-called critical process parameters, CPPs, (2) those that need to be controlled to maintain the process performance but do not influence CQAs, the so-called key process parameters, KPPs, (3) the non-key process parameters, also referred to as general process parameters (GPPs) that do not have a meaningful effect on product quality or process performance (Table 32.3).

Table 32.3

Classification of Process Parameters

Narrow Rangea Wide Rangeb

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