Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the plant digitally across the enterprise to eliminate mistakes, attain necessary approvals, and provide the complete production records required for release to sale.
The challenge with realizing this smart factory approach are appropriate integration and standardization, especially between the monitoring, supervisory and automated control level (ISA-95 Level 2) and the manufacturing operations management level (Level 3) as well as between Level 3 and the business planning & logistics level (Level 4).I caught up with Emerson’s Zuwei Jin about how manufacturers in the Life Sciences industries are addressing this challenge. Zuwei shared that based on his experiences with a number of recent engineering projects in these regulated industries, modularized, pre-made manufacturing execution system (MES) software objects have been a popular strategy to streamline such integration requirements between level 2&3 and level 3&4.
Software platforms like Emerson’s Syncade MES at S95 level 3 have been important advancements in serving these integration requirements. These platforms provided basic framework needed to properly integrate with materials management, equipment tracking, document control, quality control, workflow, and operator qualification requirements as commonly required in regulated industries. While the platforms play a key role in addressing the integration challenge, Zuwei explained that design and execution is another critical aspect in implementing Smart Factory technology. Two areas are particularly receiving the focus:
- Identifying common workflows in manufacturing processes within the industry and leveraging knowledge on platform processes such as those for Monoclonal antibody (MAb), modern cell therapy (chimaeric antigen receptor therapy – CART), and oral solid dosage (OSD). Just take Biopharmaceuticals as an example.
- Identifying common elements within the ISA-88 (S88) batch process control context in relation to materials, equipment, process variables, sampling and laboratory information management systems (LIMS) interface, and standard operating procedures (SOPs) and where they fit during design and implementation, leveraging the best practices in the industry and the industrial regulations and standards such as cGMP and S88.
Such focus led to continued standardization in engineering design. One indicator to successful implementations is the engineering design depth as reflected in the functional specifications. Through this approach, implementation and testing become smoother and less time consuming and the Good Automated Manufacturing Practice (GAMP) methodology can be readily adopted. This approach also improves consistency across project execution and ensures compliance with cGMP.
Zuwei noted that the experience in executing many of the projects in the regulated industry enables Emerson project teams to work with manufacturers to effectively provide smart factory solutions.
These experiences gained over time by the Life Sciences consulting team will continue to contribute to the standardization and integration critical to the smart factory technology and help drive this increasing industry trend toward fully-integrated smart factories in the pharmaceutical and biotech industries.
You can connect and interact with other pharmaceutical & biotech industry and manufacturing execution system experts in the Life Sciences and Operations Management groups in the Emerson Exchange 365 community.