Use of the ISA-88 facility design strategy guides plant construction teams in optimizing the breakup of plant systems into a logical framework.  This framework can be tailored to facilitate plant startup, commissioning and validation as well as and downstream expansion and reconfiguration.

 

When coupled with standardization, use of an ISA-88 modular design approach can be used to implement a series of plant features with lower costs of design and integration relative to traditional models.  These features include:

 

            Integrated 21CFR11 compliance strategies

            Plant power failure detection and automated recovery schema

            Consistent user interface design across multiple plant systems

            Simpler implementation of PAT initiatives

            Lower costs of design and integration

 

Systems designed and built using modular design approaches require less commissioning time in the following core areas. 

 

            I/O checkout

            Alarm Testing

            Security Testing

            Permissive and Interlock Testing

 

With a strong integrated commissioning and validation strategy, much of the work completed during the commissioning effort may be leveraged toward validation.  These strategies can allow plant teams to focus their effort and time on better process scale up and cycle development without lengthening timelines or compromising the rigor of the validation effort.