This chapter presents a systematic, 12-step approach for designing, implementing, integrating, optimizing, and validating a continuous manufacturing system. Wherever appropriate, it also discusses the regulatory relevance of the technology integration effort. When considering the development of a continuous manufacturing facility, the industrial practitioner is well advised to consider very carefully not only the short-term intended use of the facility, but also other needs and demands that are likely to emerge. The implementation and efficient operation of an integrated continuous facility requires a heavy dose of "process engineering" skills. A thorough understanding of pharmaceutical raw materials and intermediate blends is crucial to the successful design of a robust continuous process, wherein achieving and maintaining a steady operation is paramount. Once the properties of individual materials have been examined, the next step in the design and development of a continuous process is the characterization of individual unit operations using the actual, characterized process materials.

• Rutgers, The State University of New Jersey

• Oral doses
• Modeling

1. modeling
2. Oral doses
3. Review article