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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Consider modular automation and cybersecurity when modernizing manufacturing processes.
Many bio/pharmaceutical companies have started digital transformation projects in various parts of their companies, including manufacturing. Modern manufacturing technologies that enhance product quality and process efficiency embrace moving away from manual and paper-based processes to automated collection of digitized data that can be employed in process analytics and used to help improve overall process control. Pharmaceutical Technology spoke with Tiffany Barnes, global technical solution consultant in the Life Sciences Group for Honeywell Process Solutions, about trends and best practices in digitalization of bio/pharmaceutical processes and facilities.
PharmTech: What trends do you see in digitalization of biopharma processes and facilities?
Barnes (Honeywell): Digitalization of biopharma processes/facilities is an interesting topic because traditionally, once a facility underwent a preapproval inspection, the goal was to keep it running as long as possible without making changes (other than like-for-like maintenance). Unfortunately, this conventional approach left facilities frozen in time for fear of having to rework and revalidate. Only more recently are we seeing that the regulators are recognizing these unintended consequences. As an example, FDA has stated that they are committed to supporting and enabling pharmaceutical innovation and modernization because they firmly believe that embedded in that transformation are benefits to both industry and patients (1). And in part because of this support, we are slowly seeing cutting-edge and forward-thinking organizations begin to digitally transform their enterprise. As more organizations become a part of this transformation and their stale documents become actionable data, we see a large uptick in data integrity and a downtick in human error. What this change translates to are organizations which can begin to quantify improvements in product quality, product yield, and acceleration of new product introductions—all while maintaining regulatory compliance.
PharmTech: What trends do you see in using machine learning or artificial intelligence (AI) and real-time monitoring of biopharmaceutical processes?
Barnes (Honeywell): We are seeing a significant jump in investment and capabilities in this space. A consistent goal for facilities with biopharmaceutical processes is faster delivery of medical therapies to customers. In order to accomplish this result, these process facilities need to remain audit-ready and maintain compliance across the enterprise. This is where data analysis platforms play an important role. Advanced analytics, AI, and machine learning can minimize regulatory risk, increase operational efficiencies, and deliver products to customers faster while reducing rejections and waste of products. Advanced AI predictive models can predict equipment failures; advanced analytics coupled with AI and the Industrial Internet of Things (IIoT) can provide deeper root-cause-analysis; and consolidating compliance-related manufacturing data from disparate siloed systems enables faster lot release and increased inspection readiness.
PharmTech: What do you see as trends in modularization in biopharmaceutical manufacturing facilities? How do modular builds affect automation and process control?
Barnes (Honeywell): As the need for speed and agility has become increasingly critical, the life-sciences industry has seen a rise in modular facilities. Modularization is the enabler for facilities to serve as multi-purpose and multi-product facilities, which is particularly important for biopharmaceutical facilities that produce personalized medicine in areas such as cell and gene therapy. The flexibility of the modular approach enables life-science [drug] manufacturers to quickly change the formulations of the products they manufacture and introduce new products quicker than ever before.
As it pertains to automation and process control, solution providers must also incorporate modularity and flexibility throughout their process architectures, which means that change is also needed in the automation and process control industry. If solution providers can simplify their control system design, implementation, and lifecycle management, then new technologies can deliver the infrastructure for modular engineering that capitalizes on the flexibility inherent to modular manufacturing.
PharmTech: What are the primary challenges for automation of modular processes?
Barnes (Honeywell): In general, traditional automation did not support modular processes as effectively. It is the modular processes and need for agility that have been pushing the automation providers to become more flexible in their solution architecture. For example, the days of tightly bound physical relationships between controllers and input-output (IO) devices are becoming a thing of the past. Realistically, automation solution providers must break free of those legacy constraints, begin looking at their existing technologies, and make significant investments in solutions that intrinsically support modular engineering. There has been a significant step change with new innovations in cloud computing, technologies that decouple control from the physical platform, and the use of simulation environments with virtual systems. These advancements are also critical in supporting the biopharmaceutical industry as a whole as they adopt workflows that heavily leverage contract manufacturing organizations who often need to supply different products for their clients. Automation solutions that are leveraging these technologies are on the path to building a necessary foundation to implement modular engineering strategies that meet ever-changing sector demands.
PharmTech: What options are available for automation of modular processes?
Barnes (Honeywell): There are two main approaches for implementing automation solutions for modular processes. One is the traditional approach, where there is a one-to-one relationship between IO and controllers. Another is decoupling control from the physical platform.
The traditional approach is not conducive for modular facilities that require agility. The rigid architecture reduces engineering flexibility and increases overall cost as hardware is often fixed. An automation solution that has the capability to decouple the controls from the physical thrives in a highly adaptive environment. This approach would usually require an information technology infrastructure to support a data center or virtualization technology where controls and IO can move effortlessly. This [approach] brings elasticity to the control system architecture by enabling manufacturers to change the IO footprint when adding or moving equipment. In effect, IO becomes an extension of the equipment that can be managed independently of the control system infrastructure.
PharmTech: What are the concerns with data integrity and security when connecting equipment via the IIoT, and how can these concerns be addressed? What are the primary concerns for data security/data integrity for modular processes in particular?
Barnes (Honeywell): As the industry heads into digital transformation, inevitably there is an increase in connectivity across the enterprise. With respect to an IIoT device, data can exist in motion, at rest, and in process. When data integrity is compromised, this not only means that an IIoT device cannot operate correctly, but it can also mean that the device is now open to being exploited as a potential launching point for other attacks within the enterprise. Modular process managers must be cognizant of these risks because there is a potential for more touchpoints and insertion opportunities. Traditionally, security has been viewed as a cost center but, in reality, it is a competitive advantage as systems remain up and running and unplanned downtime is eliminated. Facilities need to manage the risk that comes up at different stages in the cybersecurity lifecycle. To do so, security must come to the forefront and organizations must apply the right technology and best practices at both the device and platform level.
PharmTech: Can you comment on what the biopharma industry could learn/adopt from other industries regarding these technologies?
Barnes (Honeywell): There is a lot to be gained in the biopharma industry by both learning and adopting processes and best practices for IIoT and cybersecurity from other industries. Refineries, chemical plants, and other automated industries have a long history of mitigating safety and security risks. Often, risk in those industries can result in devastating human loss in addition to the impact on production. Over the years, those industries have found that security and safety are tightly integrated with more than just technology—that people and the work process contribute to the overall data integrity of the facility. Therefore, though there are many lessons learned, one of the important concepts that the biopharma industry should adopt is an integrated safety and security approach that includes what other industries refer to as layers of protection. This comprehensive approach begins with understanding pertinent regulations and standards and how they affect the various layers of protection. Then it looks to incorporate the work process and practices that make use of and maintain the technology as well as the people that interact with the technology and work practices. Looking at how to maintain data integrity holistically is key to formulating successful safety and security philosophies.
1. Axendia, Digital Transformation and Manufacturing Modernization, Ebook (2020).
Vol. 44, No. 11
When referring to this article, please cite it as J. Markarian, “Adopting Digitalization in Biopharma Facilities,” Pharmaceutical Technology 44 (11) 2020.