Abstract: This article discusses the choice of thin-cake (2-25 mm) separation technologies and their benefits to optimizing the effectiveness of the production process. The paper continues with a discussion of clean-in-place operations to meet current Good Manufacturing Practices (cGMP) guidelines including riboflavin test and validations. ANSI/ISA S88 (and IEC 61512-1 in the international arena) batch process control system standards are also examined. Finally, factory and site acceptance testing is described.

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