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Pharma 4.0 and Digitalization in Pharmaceutical Manufacturing

Turkchem 28 Oct 2021 40 5 dk okuma
TURKCHEM
Pharma 4.0 is a term used to define Industry 4.0 in pharmaceutical manufacturing. Much has been written about how the Industrial Internet of Things (IIoT) or the 4th Industrial Revolution has transformed the automotive, manufacturing, aviation and agricultural sectors. Here, however, we will examine how Industry 4.0 affects pharmaceutical production from different angles. The pharmaceutical industry faces various challenges related to quality, efficiency and cost, and IIoT can help the industry cope with these challenges. Today, pharmaceutical manufacturers worldwide must remain competitive in a growing pharmaceutical market, and digitalization in pharmaceutical manufacturing can help increase its competitiveness. The pharmaceutical industry is one of the most heavily regulated industries, and product monitoring is always required as laid out by regulatory authorities. Traditionally, in the past, an annual quality review was sufficient. However, this is no longer the case, as there is growing consumer expectation that manufacturers conduct systematic reviews more frequently than before. Developments such as IIoT enable continuous and real-time monitoring of such operations. This allows manufacturing companies to ensure there are no deviations from specified parameters. Any unwanted events can be predicted and corrected. Thus, it is possible to avoid any problem or financial loss that could damage the pharmaceutical manufacturer's reputation. The use of this technology not only allows products to be developed faster, but also puts pressure on R&D departments to deliver more personalized treatments. Pharma 4.0 provides connections between machines, human workforce and computers at various levels. In an intelligent pharmaceutical plant, connected components can independently: report their own status, suggest expiration dates and accurately predict a fault or degradation. As a result, there are major savings in many respects. However, to fully benefit from sensors and the data obtained from them, all this data must be processed using advanced analytical tools and algorithms. Aspects such as predictive analytics and cognitive intelligence play an important role in this field. Analytics plays an important role in obtaining data from disconnected sources; additionally, it searches for previously undetected patterns, relationships and trends. The digitalization of assets, data and processes in the production value chain enables the pharmaceutical industry to transition to a more results-driven ecosystem, thereby providing greater benefits. Below is a demonstration of some important applications of IIoT in pharmaceutical manufacturing.

Challenges in Digitalization of Pharmaceutical Manufacturing

Despite the numerous ways IIoT could benefit pharmaceutical production, there are also some challenges. • The cost of upgrading all legacy equipment to more digitalized equipment is a barrier, but this cost can be quickly recouped with tangible results (higher productivity and reduction in time loss and waste): • As academia struggles to anticipate the strategic skills the industry will need in future years, finding sufficiently skilled human resources with advanced skills (such as a comprehensive understanding of analytics) is also one of the challenges. Despite uncertainty, it is clear that advanced analytics skills will continue to be in demand in the coming years. • Security emerges as one of the most important issues, since Pharma 4.0 will mean connecting hundreds of thousands of devices such as sensors, machines and networks to each other. Each connection in turn can be a potential vulnerability point in terms of system security. Therefore, to fully benefit from Pharma 4.0 advantages, manufacturing companies will need to reduce these security risks by becoming more willing to invest in qualified security personnel. The topic of Pharma 4.0 is still far from being fully understood. Progress so far can be likened to babies taking uncertain steps toward an unclear destination. However, the following are some guidelines for companies wishing to adopt the benefits of Pharma 4.0 in their plants. • Automation, quality, workforce, efficiency, integration and collaboration are critical factors that will play a fundamental role in shaping future smart factories. Companies must be able to address all these factors to ensure that their Pharma 4.0 programs are sustainable in the long term. • Companies should proactively work with other stakeholders in supply to create a system in which data, raw materials and products can move faster and more efficiently. Equipment and machinery suppliers should play an active role in facilitating these processes. • Companies should invest in R&D and be willing to encourage technological innovation in new equipment, software and services that can integrate seamlessly with each other and function as a single intelligent asset. Data in any form has value. Advanced analytics can be performed to analyze existing data sets to provide useful information. • Although Pharma 4.0 seems to talk about intelligent machines, integration, smart methodologies and efficient processes, everything ultimately depends on any company's greatest asset - its human workforce. The human element is a critical success factor in any 4.0 implementation. Therefore, appropriate efforts should be made to nurture talent and protect the interests of the workforce. Furthermore, it must be understood that the purpose of Industry 4.0 is not to stay away from people and replace them with faster, more efficient machines. Instead, it is to encourage working with machines on value-added activities where human creativity and problem-solving capabilities can be best utilized. Although pharmaceutical manufacturing is a risk-averse industry, there is regulatory support as it takes baby steps toward Pharma 4.0. Barriers will diminish over time and Pharma 4.0 will become the new standard in the pharmaceutical industry.

Pharmaceutical Production Process Deployed with Robot Implementation

Pharmaceutical manufacturers now rely on automatic robotic systems for efficient and controlled material use in the pharmaceutical production process. The high initial costs of robotic devices have limited the application of robots in the pharmaceutical industry. However, current computer and environmental systems have enhanced the flexibility and capabilities of robot technology. The most common applications of industrial robots in the pharmaceutical industry are manufacturing and packaging. Benefits of Automation in Pharmaceutical Production The following are the main benefits of using robots in the pharmaceutical production process. • High speed and efficiency, • Better production flexibility, • High cost reductions, • Consistent product quality.

The Future of Robots in Pharmaceutical Production

Like other industries, the pharmaceutical industry is also striving to increase the sustainability of its operations by using robots. In the past, robots were used only in food and automotive industries for mass production operations. However, since robotic systems have become more accessible in terms of cost and size in recent years, they are now also widely used in small-scale production processes such as pharmaceutical manufacturing and drug discovery.

Conclusion

With increasing competition in the pharmaceutical industry, pharmaceutical manufacturers are seeking ways to increase production efficiency and their ability to produce high-quality products at low cost. Robots help pharmaceutical companies achieve these goals by providing advanced flexibility, repeatability, speed and precision. Manufacturers believe that robots could prove extremely powerful in the future in discovery, pilot production and development of small-scale pharmaceutical products.
Sources / References 1. Demir, N; İlaç ve İksir, Gece Kitaplığı, 2021
  Prof. Dr. Nazan Demir Faculty of Sciences Chemistry Department Muğla Sıtkı Koçman Üniversitesi
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