查看文章

Validation is a critical stage of the equipment design process as it provides documentary evidence that the equipment is performing as per specification and ensures consistent product quality is maintained at all times. The advent of Industry 4.0 has led to a requirement for reconfigurable manufacturing systems as manufacturers adapt to an increased customer demand for personalised products. As equipment control software becomes increasingly complex to accommodate these requirements, a new approach to equipment validation is required. This paper presents a methodology for the design and validation of equipment in regulated manufacturing environments, using a model-based design platform (MathWorks^® Simulink^®) to model and digitally validate the Programmable Logic Controller (PLC) code required to control manufacturing equipment. A workflow is presented detailing the steps required to implement this approach and a demonstration model was developed as a proof of concept. Validation documentation and PLC code are automatically generated based on the system model and the functionality of the generated PLC code was successfully verified on a physical demonstrator, proving the feasibility of the proposed approach. Adoption of the approach outlined in this work would enable manufacturers in regulated industries, such as medical devices and pharmaceutical products, to rapidly design, build, reconfigure and revalidate manufacturing equipment as required to accommodate an increased demand for customised products.