Walvax (SHE: 300142) recently formed a strategic collaboration with Honeywell (Nasdaq: HON) that led to the construction of China’s first mRNA COVID-19 vaccine production plant.
The company has been working since 2017 to become a leading vaccine R&D company, recounted Shawn Opatka, vice president, life sciences, Honeywell Process Solutions. “Their goals accelerated the construction of a digital-enabled center for vaccine production, and vision for a smart factory,” he said.
When building the mRNA vaccine plan, Walvax used Honeywell’s intelligent plant technology to enable the digital production and operation of the smart plant.
First, the companies collaborated on deploying a supervisory control and data acquisition (SCADA) system pilot for other projects. “Since then, Honeywell’s solutions have been gradually introduced and deployed at various levels,” Opatka said.
In the following interview, Opatka shares more details on the Walvax alliance, sharing an overview of the deployment of batch process control and building management systems (BMS) and environmental monitoring system (EMS). Opatka also shares details on how the plant supports high-quality production conditions for mRNA-based COVID-19 vaccines?
PPW: How typical was this deployment?
Opatka: This deployment consisted of step-by-step process and batch control systems, BMS/EMS, MES, QMS, WMS, electronic batch records for vaccine production, data integrity, quality and compliance and cybersecurity. An integrated solution that improves traceability and transparency with data capture, recording and reporting that simplifies and protects compliance, helps maintain audibility, optimize production and speed time to market while ensuring quality and repeatability.
PPW: Can you give an overview of the batch process control?
Opatka: Honeywell’s Experion batch processing technology has unique features to advance production and reliability.
Manufacturing processes (including reactors, ultrafiltration and media containers) can be automated and optimized with our control systems. From the simplest sequence to the most complex recipe, we can efficiently monitor and control every batch. Honeywell Experion Batch technology combines distributed control, batch automation and batch visualization to optimize availability, productivity and reliability.
Batch processing is a program composed of processes, unit processes, operations, and stages. We configure the recipe in the same Experion environment as other Experion control schemes. The formula elements can be configured in series or parallel and can be cycled as needed. There is no limit to the number of program elements. The recipe has associated parameters, which are usually used to store fixed-point processes, raw material quantities, routing information and process variable reports.
Honeywell Experion Batch processing technology provides unique advantages:
- Improve the availability of batch execution by executing complete programs in redundant controllers in the same environment.
- Increase production by reducing and delaying batch processing execution time between applications at different levels.
- Improve operator usability through display integration and interactive instructions.
- Cover all levels of sequence functions in the ISA S88 model.
- Reduce formula maintenance through a master formula independent of the equipment.
- The patent-protected visualization technology presents the current and future operating status in a natural and intuitive way.
PPW: What can you share about the BMS/EMS system deployment?
Opatka: Honeywell BMS/MS system mainly includes servers, UOC controller I/O, and network hardware equipment also including FI/Valve. The system requirements involve GMP elements that meet relevant requirements of the US FDA and GAMP5 for computer system verification.
PPW: What about the deployment enables high-quality production conditions for mRNA-based COVID-19 vaccines?
Opatka: The COVID-19 vaccine plant is located on the first to fifth floors of Building 301 in Yuxi WALVAX. The goal of this project is to install a decentralized control system to control and monitor the following system data for two mRNA and one adenovirus production lines: media configuration system, buffer configuration and storage system, harvesting system, purification system, CIP module and provide all hardware, software and licensing, system programming, system debugging, system verification, training, etc. of DCS.
PPW: Can you talk more about the goal of realizing the “building an intelligent plant” mentioned in the press release?
Opatka: Taking the Yuxi WALVAX Intelligent Factory as an example, we must achieve the following goals:
- Process and batch control through step-by-step deployment, BMS/EMS, MES, QMS, WMS (warehouse management system), etc. for vaccine production electronic batch records, data integrity, quality and compliance, cybersecurity.
- Use big data analysis and machine learning to deepen the research and development of device interconnection and edge computing. Improve production safety and operator skills.
- Explore how to use the latest virtual reality technology, mobile technology and digital technology to promote operator skills training, process management of equipment maintenance processes, AR/VR technology applications, production alarm management, DCS loop performance management, etc.
- Starting from the Walvax base in Yuxi, electronic batch records of vaccine production for key varieties will be completed before July 1, 2022.
- Taking Yuxi WALVAX Base as the starting point, initially realize the visualization of the cockpit and digital twin, laying a solid foundation for management visualization.
- Expansion of QMS functions based on business requirements.
- Further integrate data of WMS and ERP to realize the informatization of warehouse management.
PPW: Can you also provide a brief overview of Honeywell’s work on Pharma 4.0 initiatives and provide some perspective on how mature Pharma 4.0 adoption currently is?
Opatka: As far as the benefits of 4.0 go, they are immense as our customers realize that their ever-overarching scheme speed is now going to make an impact. This technology, when applied, helps us know how a certain parameter relates to another parameter, and also, business analytics and adapting to requirements becomes easier. The correlation can be run quickly and the impact on speed can be dramatic.