OR WAIT null SECS
Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
The Internet of Things (IoT) is portrayed as having things such as a “smart” refrigerator able to sense and send a message to a smart phone or to the grocery store when the milk supply is low. The Industrial Internet of Things (IIoT), similarly, is a network of equipment with sensors that collect data in real time and communicate them to other machines or people using the cloud or internal company systems.
Manufacturing equipment may already be connected and controlled by supervisory control and data acquisition (SCADA) systems that feed data into manufacturing execution systems (MES), which collect and manage manufacturing data, and distributed control systems (DCS), which control the equipment (e.g., turning valves off and on). The IIoT is an additional system, characterized by “big data” that has the potential to be harnessed to improve manufacturing efficiency.
“Increasingly, manufacturers are using big data and advanced analytics to scrutinize the massive amounts of data being collected by their smart machines. These evaluations are yielding valuable insights into plant workflows, including predicting maintenance needs before equipment breaks and tracking parts as they move through the supply chain,” according to vision-guided vehicle inventor Seegrid (1).
Pharmaceutical Technology spoke with Honeywell Process Solutions’ Torsten Winkler, leader at the company’s Center of Excellence Life Sciences EMEA; Melissa Topp, director of Global Marketing and Oliver Gruner, director of Cloud Business Development at ICONICS; Mark Bottomley, Life Sciences industry leader for EMEA, Rockwell Automation; and Andrew Whytock, in Global Business and Solution Development at the Siemens Pharma Competence Center in Karlsruhe, Germany, to gain further insight into the IIoT in pharmaceutical manufacturing.
PharmTech: What are the primary benefits for using the Industrial Internet of Things in pharmaceutical manufacturing?
Whytock (Siemens): The benefits for traditional large-scale pharma or biotech manufacturing are similar to those experienced in other industries; these usually revolve around connected data, providing a better understanding of performance and utilization of equipment, and an ability to predict maintenance and prevent breakdowns. In my opinion, the key distinguishing feature of the pharma industry is the requirement to document and record everything that happens during production for compliance reasons. IIoT could therefore become a catalyst for paperless production, as equipment and recipe parameters become more closely connected and available, meaning less manual interventions could be required. In addition, as the industry moves toward smaller-scale manufacturing, even to the extent of individualized production or outcome-based and diagnostic-focused therapies, the IIoT will provide the ability to capture the data and connect complex equipment and processes, providing insight to the process, not just performance and efficiency.
Bottomley (Rockwell): Pharmaceutical manufacturers that implement IoT technologies can more easily meet requirements for serialization and have the opportunity to leverage intelligent data that are already required in the pharmaceutical manufacturing environment. They can connect their equipment, networks, and systems to share information across the plant floor and up to the executive suite, and standardize their processes. Previously, pharmaceutical manufacturers stored production information on paper for reference--making it more difficult for operators or executives to make process or business decisions. With a smarter plant and an IoT-enabled solution, manufacturers can access data in real time to better monitor production and gain visibility from production to distribution. Manufacturers can also more easily pull the data to track-and-trace products in the case of an issue and immediately recall the specific affected products more quickly and efficiently. Overall, this helps manufacturers improve quality by design and gain a clearer understanding of their processes--helping improve consumer safety and protect the company brand.
Winkler (Honeywell): IIoT provides the infrastructure that allows data collection to be extended into various layers of automation and information technology (IT). More specifically, data collection for analytics or electronic batch records enables cheaper and faster data integration, without disturbing the control system.
Another aspect of the IIoT in pharma is the modularization of pharmaceutical production plants. IIoT infrastructure allows modular automation for modular pharmaceutical production to scale production up or down according to the market needs. This enables faster time-to-market for pharmaceutical products in accordance with the regulations and required approvals for specific markets and regions.
Topp and Gruner (ICONICS): The most exciting benefits that we see center on real-time monitoring and control, optimized decision making, reduced costs, and improved patient outcomes. Part of the reason this has all become possible is because advances in sensors and IIoT gateway devices have made them much more affordable to provision, while maintaining the same strict level of security and regulatory compliance mandated by the industry.
PharmTech: How would you characterize the current state of the IIoT in pharmaceutical manufacturing?
Winkler (Honeywell): The pharma industry is beginning to realize the benefits of the IIoT, especially through modularization, which is already in the detailed implementation and usage state. One example of companies reaping the benefits of this technology is Pfizer’s PCMM collaboration with GEA and G-Con. Additionally, companies have started implementing OPC UA [unified architecture] into the device level to enable more detailed data analytics. The full potential of the IIoT, especially for the pharmaceutical industry, requires the adoption of advanced industrial cyber-security practices and the completion of validation aspects.
Whytock (Siemens): At the moment, IIoT is just one of the technological drivers that is shaping the future of our industry, being closely related to other high-focus topics such as the cloud and big data. The pharma manufacturing plant of the future will need to embrace and connect these different technologies, understanding the role that robotics can play and how to collaborate with them. The requirement for direct and on-demand access to materials and all their properties, including through contract manufacturing organizations (CMOs) and external suppliers, will increase. Today’s MES, data historian systems, and control systems are proving the basis for collecting and storing the data that are being collected. Closer integration of these systems is essential for the future. Direct communication between objects or via the IIoT is not yet widely seen.
At a production level, the current focus of the industry is to connect the production data using MES, process analytical technology, and control and automation systems. Linking automated and manual operations provides the ability for companies to realize paperless and continuous manufacturing. Digitalization and paperless manufacturing are therefore a reality in some plants, but most companies still have some way to go to understand how they can incorporate IIoT equipment and technology in their existing processes. For new processes, such as in individualized batches, more work has already been done and some successes are being achieved.
Standardizing the way machines communicate is crucial to connecting them effectively. OPC unified architecture (UA) is a platform-independent, machine-to-machine, industrial communication protocol, which “is the key technology for connecting devices in an industrial setting and ultimately making it an IIoT [Industrial Internet of Things] device,” say Honeywell Process Solutions’ Torsten Winkler, leader at the company’s Center of Excellence Life Sciences EMEA, and Andrew Duca, engineering director, Digital Transformation. “Not all devices need to be connected to the internet to provide value to the larger IIoT ecosystem, and in fact, these existing devices can be interconnected through specialized IIoT gateways, SCADA, and DCS systems. OPC UA is a key enabling technology for bringing data from all of these systems together.”
Another key technology, say Winkler and Duca, is the management and communication framework spelled out by the Reference Architecture Model Industrie (RAMI) 4.0, which was published in 2015 by the German Electrical and Electronic Manufacturer’s Association (ZVEI) and its partners. RAMI 4.0 provides a basis for coordinating national (German) and international standards to further develop “Industrie 4.0,” which, according to ZVEI, “stands for the complete digitization and integration of the industrial value chain…[and] the realization of the smart factory in the digital value network” (1); the German government initiative is closely related to the IIoT. Other modeling and terminology standards include those from the International Society of Automation (2) and the International Electrotechnical Commission (3, 4).
PharmTech: What is needed for pharma manufacturing to use IIoT more optimally?
Whytock (Siemens): A better understanding of IIoT is required, both from manufacturers and suppliers. IIoT is often restricted to small-point solutions that focus on a specific need (e.g., cell culture), meaning that the true potential is not often realized. Process scientists and R&D need to better understand about advances in manufacturing technology when researching and deciding on new formulations or therapeutic delivery methods.
The challenge for the future of manufacturing is highly flexible with adaptable automated production. Today, there are still a lot of manual processes in drug substance and drug product preparation. Managing the data and being able to make automatic adjustments or decisions based on the data implies advances in the management of the data and the willingness to trust in the systems that are collecting [the data]. In addition, the different stakeholders in the plant need to work better together, across the traditional silos such as production and quality.
Another aspect that is often forgotten is how the people will interact with the data. Which people need which data? In today’s manufacturing environment, a lot of data are produced but are not always consolidated or contextualized. Providing innovative and effective ways for operators and managers to interact with data will be key.
Topp and Gruner (ICONICS): The benefits of applying an IIoT strategy in pharmaceutical applications, such as increased visibility and integration of information, do not happen automatically. IIoT-friendly sensors provide massive amounts of big data, but it is then up to the manufacturer to deploy IIoT software applications for visualization, analytics, and mobility that enable proactive decision-making and real-time visibility into the process. Such applications are available today, allowing pharmaceutical manufacturers to make sense of big data in the cloud and to make timely decisions based on actionable information.
PharmTech: What are the primary concerns for pharma companies setting up to connect their systems?
Bottomley (Rockwell): Pharmaceutical manufacturers want to maintain the quality and safety of their product above all. Low-quality product release can impact consumer health and damage a manufacturer’s image and bottom line. As a result, when implementing IoT technologies, manufacturers are concerned about security--of their data, manufacturing process, and intellectual property. To help improve plant and product security, manufacturers can implement a defense-in-depth approach that includes security measures at the physical, application, and device level. This approach allows for new and upgraded security measures to be applied in stages, instead of significant rip-and-replaces, reducing the unnecessary impact of critical processes and the need for revalidation of larger production areas.
Crossover of the IT and operational technology (OT) environments remains an issue, and needs careful consideration. The enterprise level of large pharma companies will have established security procedures, which may be applicable to the manufacturing and operations space. However, these may not have been designed with this environment in mind.
Whytock (Siemens): Manufacturers are primarily concerned about the data. Once I connect an ‘object’ from my manufacturing plant, I am increasing the risk. How is it managed? Is it secure? Can I access it quickly to be able to show to FDA? The risk-averse nature of the pharma industry will undoubtedly play its part in slowing the adoption of digitalization and IIoT. The key question will be for pharma companies to be sure that the benefits outweigh these risks. Companies that are able to confidently and easily deploy systems will get the most benefits. It will, therefore, come down to robust cybersecurity and having the right people and technology partners as key collaborators in this journey.
Winkler (Honeywell): Security and validation aspects covered by global standards will be an initial concern for many industries, including pharma. The pharmaceutical industry must adopt more advanced cyber-security practices and validation standards like those of the International Electrotechnical Commission (IEC) or International Society of Automation (ISA).
PharmTech: Are other industries ahead of pharma manufacturing in developing IIoT? Are there examples that companies can look to?
Winkler (Honeywell): The automotive industry is rapidly adopting IIoT technologies and is one example of a non-validated manufacturing environment that’s ahead of pharma at the moment. That said, pharma is not far behind; some examples of companies leading the way in this industry are Pfizer, JHL Biotech, and Sanofi-Aventis.
Whytock (Siemens): It is generally considered that industries that focus on assembly and discrete manufacturing, such as medical devices or automotive, are ahead of pharma. One aspect has been the introduction with product lifecycle management systems, proving data integration right through the product, plant, and production lifecycle.
1. Seegrid, “IIoT: The Next Frontier for Manufacturing,” http://blog.seegrid.com/hubfs/Ebooks/IIoT_The_Next_Frontier_for_Manufacturing_ebook.pdf
Article DetailsPharmaceutical Technology
Vol. 40, No. 9
When referring to this article, please cite it as J. Markarian, "The Internet of Things for Pharmaceutical Manufacturing," Pharmaceutical Technology 40 (9) 2016.