Issue link: https://www.e-digitaleditions.com/i/1468049
46 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Aseptic Processing vation. There are two main challenges a drug manufacturer must face. The first is to change not only the organization's mindset across all levels in the company but also the mindset of the ecosystem it operates in, including equipment manufacturers, integrators, and other suppli- ers, from conventional approaches to a mind- set that embraces digitalization and robotics. The second challenge is to find solutions that meet good practice (GxP) requirements or that need minimal customization to be applied in a GxP environment. As if this were not enough, in most cases installing a single robot is not a comprehensive solution. Instead, an isolated ap- proach can generate further challenges. So, the cards are on the table. What are good reasons to continue automating? For employ- ees, robots mean less monotonous work and the freedom to focus on creative, value-adding tasks. Under the narrative that reproducible processes lead to higher quality products, higher automa- tion means improved product quality and more affordable products for the patients. Based on these and other goals, the following criteria are of great importance to the business: • capacity increase • cost efficiency • sustainability • quality and compliance • improved yield. All in all, multiple factors must be taken into account in order to find a holistic solution to an existing problem. Lights-out operations A number of interdependent steps need to be taken to achieve lights-out operations in aseptic manu- facturing. Concepts for robotic aseptic filling are now available and, in the coming years, the indus- try will see more gloveless filling lines in commer- cial manufacturing. For contactless manufacturing (reducing risk of human contamination to zero), the step to automate the filler is necessary but far from sufficient. The core activities of aseptic phar- maceutical manufacturing also include logistics (i.e., material handling), sampling, quality control (QC) laboratories, cleaning, and disinfection, to name a few. Not surprisingly, the more steps of the process that are automated, the greater the po- tential impact on target criteria, such as capacity increase, cost efficiency, and sustainability. However, even with that awareness, a lights-out or "Factory of the Future" concept is undoubtedly an abstract and complex matter, and within one orga- nization, multiple players interact. However,it is not unachievable, giving it sufficient thought and time. Figure 3 uses the example of fill/finish and pack- aging operations to map and visualize some of the various factors with which robotics technol- ogy interacts. These aspects are built in sequence from the basic information technology/operational technology (IT/OT) architecture to the ultimate Factory of the Future with lights-out operations. On a side note, the idea can be applied to most technologies because it builds around the core pharmaceutical business and takes IT/OT infra- structure, enablers, and the vision into account. Even with that awareness, a lights-out or "Factory of the Future" concept is undoubtedly an abstract and complex matter.