Introduced as a critical future project of the German government in 2012, Industry 4.0 is about establishing a "Smart Factory" by applying cyber-physical systems, internet of things, cloud computing, etc. to strengthen the competitiveness of the manufacturing industry. In other words, a smart factory is a factory in which mutual communication is automatically settled with all processes connected, not just a single part of the production process.

The requirements for the smart factory construction process include (a) standardization, (b) system management, (c) communication infrastructure maintenance, and (d) safety and security. The companies could save money when connecting all the facilities and services by simplifying and standardizing them. Since the entire system is connected, the complicated system can be operated normally only after special management has been done, so system management and reliable communication infrastructure equipment are needed. Moreover, if the security is weak, there may be problems in the entire process, so safety and security must be essential.

The realization of Industry 4.0 means the integration of the entire process, including product planning, manufacturing, and distribution. In addition to increasing economic efficiency as a result of energy-saving and a safe production environment, productivity is improved as a flexible production system is established. A much larger number of mass productions are possible, personalized products can be delivered to customers quickly, and the probability of defective products can be significantly reduced. On top of that, companies can invest more in the product development process or seek new business opportunities by saving costs and time through smart factories.

▲ Pharma 4.0, published by ISPE, is a new pharmaceutical manufacturing process paradigm introducing Industry 4.0. (Image source: ISPE)

As a result, many factories are rushing to begin a smart factory, and especially in the pharmaceutical industry, it seems to adopt in earnest from last year. In November 2017, the International Society for Pharmaceutical Engineering (ISPE) announced a new pharmaceutical manufacturing process paradigm, "Pharma 4.0", which introduces Industry 4.0 to advance the pharmaceutical manufacturing process in line with the fourth industrial revolution. Many experts are expecting that the introduction of Pharma 4.0 will enable effective shortening of the time and cost of pharmaceutical processing and thus the infinite development of the pharmaceutical industry.

Especially in the case of the pharmaceutical industry, hygiene management is crucial in the entire production process, so it is necessary to minimize the possibility of contamination. For this reason, the pharmaceutical industry has changed the production process several times. Until 2015, the industry had been using a "discontinuous manufacturing" that used batch production methods to check the quality of each drug at the end of each stage for more than 50 years. Not only did it take a long time, it had problems related to hygiene and quality, such as contamination, which could be caused by frequent movement of drugs.

However, since 2016, a "continuous manufacturing" has been introduced, allowing quality checks at any time during the manufacturing process and reducing manufacturing time and operating costs by up to 50%. And what Pharma 4.0 is ultimately trying to achieve is the introduction of continuous manufacturing, a method of connecting all the processes required for production. Continuous manufacturing is based on the Quality by Design (QbD) system and Process Analytical Technology (PAT).

Unlike the existing GMP system, where the manufacturing process and quality management are separated, QbD system can simultaneously perform real-time monitoring during the process. Through this, the risk factors that can occur at all stages of pharmaceutical production are identified and managed in advance. Also the process can be continuously managed to produce products of consistent quality under optimal conditions in real-time, thereby improving and guaranteeing quality.

PAT, along with the QbD system, is a technology that enables real-time monitoring of the whole pharmaceutical manufacturing processes. The PAT sensors with IIoT collect and manage information such as temperature, pressure, and weight in real-time in all processes of the factory. The mostly used PAT technologies include NR, Passive Acoustics (PA), Thermal Effusivity (TEE), and Video Capture (VC). Besides, PAT features an increase in production efficiency by reducing production cycle time.

▲ Boryung Pharmaceutical has introduced a smart factory with automated processes from production to packaging and delivery. (Image source: Boryung Pharmaceutical)

From 2018, there has been a gradual attempt to introduce Industry 4.0 in the pharmaceutical industry, and several pharmaceutical companies have recently completed or are in the process of building. However, the pharmaceutical industry in Korea is still at the early stage. Still, many companies are hesitant because of cost issues, conflicts between departments, security issues, employment issues, stereotypes, etc. Among them, some tasks cannot be solved in a short time or have to be solved socially. However, it is correct that smart factories have become the core strategy of the manufacturing industry ecosystem in advanced countries.

In the near future, it seems that more and more pharmaceutical companies will reduce the probability of contamination and defective products during the manufacturing process and solve the quality-related problems. Also, they will decide to adopt a smart factory that can provide not only generic drugs but also personalized drugs to customers. Rather than producing dozens of drugs with different packaging and the same contents, now companies will have to invest more in the research and development sector in order to have competitiveness.

The existing smart factory will also continue to develop. With data analysis and prediction through artificial intelligence and machine learning, as well as 5G released last year and the hybrid cloud, it is expected to be much faster and smarter. To solve the difficulties of mass production of diagnostic kits caused by COVID-19, the Korean government recently announced that it will support the construction of smart factories based on data. This can be a good example of the importance of smart factories in productivity. At this point in which everything is being digitized, it is now vital to become smarter.


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