The GMP manufacturing facilities regulatory nature requires a high degree of focus on product quality, system validation, and manufacturing records. A multi-unit batch recipe control approach based on the S88 model using an integrated system including data management provides highly significant benefits over the unit-based PLC approach while these objectives can be met with manual operations or unit-based automation using PLCs. The Emerson Process Management DeltaV digital of automation system can result in dramatic improvements in the way batch automation is implemented, executed, and validated.
Multi-unit recipe control can be implemented with a component- based or with an integrated batch automation system architecture using PLCs, MMI software, batch packages, and historian packages. The PLCs component-based architecture is a highly engineered specific solution to a project. It requires integration and selection of a variety of software packages. Each package is designed to be an independent product with a minimally designed, generic linkage to other 3rd-party software packages.
Each software system has to be installed, interfaced, and configured to the other software components. These hardware/software purchase price of components appears to be low. However, the cost to configure, validate, interface, and document the implementation of a component-based architecture significantly increases the total installed cost for the solution. The total maintained cost is higher. It must be configured, interfaced, validated, and documented, every time a change is made to the system. Also, since the configuration of the automation system has been declared to be a GMP record by the FDA, any changes made to the solution must be made under careful change control.
The more functional areas that require manual changes, the more complex the change management implementation will be. Regarding integrated design, the DeltaV system has all components designed to use a single configuration database. All DeltaV functional areas and applications are designed to work together such that the need to interface/link components and manually map data between applications is eliminated.