Chapter 20 - Flexible continuous manufacturing—based on S88 batch standards and object-oriented design

Abstract

Abstract This Chapter presents a flexible design approach for a continuous manufacturing (CM) plant for oral solid dosage. The flexible design approach is based on object-oriented design (OOD) principles and the adoption of the ISA S88 Batch Standards for Continuous Manufacturing. As the industry trend moves away from Blockbusters for Batch, the trend will also be true for CM. Due to the high capacity nature of CM plants, it will be the exception rather than the rule that a CM plant can be dedicated to a single product. It is more likely that a successful business model for a CM plant will include a portfolio of products. As the capacity is exceeded for one plant, another one will need to be built until a suite of CM plants can handle a diversity of products. Each plant will be similar but can be designed in a unique way to specialize in a unique target set of products. A plant that could be designed with more process flexibility than is the standard today will better fit new business trends that require smaller volume and target specific drugs as opposed to large-scale blockbusters. The opportunity exists for CM to meet these needs if flexibility is designed-in from the earliest stages of conceptualization. The perfect scenario would be to efficiently “mix and match” multiple unit operations to make multiple products as need with minimal validation change control procedure. The OOD approach is the basis for creating a flexible system that allows for the interchange of disparate unit operations and creation multiple processes on the same line. This facilitates the ability to generate multiple products on the same line, streamlining the CM business case by eliminating the argument for using Batch for small-volume products. S88 provides the software framework to support the flexible object-oriented approach. This chapter discusses the business needs for CM as it pertains to a flexible design. It outlines the methodology for developing a flexible process through the use of OOD and the reasons for using S88 as the framework for CM. Finally, the chapter lays out the entities that are supported by this design approach including materials traceability, raw material tracking, batch reporting, process analytical technology (PAT), advances controls, optimization, design-of-experiments (DOEs), and recipes.