Description
Intended as an introduction to the design of pharmaceutical secondary manufacturing facilities, this book illustrates many of the concepts and constraints that have to be considered in these designs for small, medium and large scale production plants. The layout, flow of materials and personnel through the facility is considered with reference to ensuring compliance with current good manufacturing practice. The benefits that can be obtained from using automated totally enclosed systems for small production runs is demonstrated for sterile operations and solid dosage systems. One example given shows the concept of a solid dosage facility as a model to show how integration can be achieved to minimize cost, and improve productivity and product elegance. Concepts such as Computer Integrated Manufacturing (CIM) and Just In Time (JIT) are discussed. The book shows how clean rooms have developed, and how their design has been improved to reduce contamination levels from the operator and the construction and finishing materials used. The ideal facilities are outlined, illustrating the design considerations that need to be applied in a modern dosage manufacturing facility to enable the systems to be validated to current standards.
