[Report] "Becoming 'Smart' Brings 'Super-Gap' in Quality... Daewoong Pharmaceutical Osong Smart Factory

Completed in 2017, Smart Factory 'Stage 4' Certification
All Processes Automated Except Initial Raw Material Input
Productivity Index Up 40%... Workforce Down 25%

"Quality management is the most important factor in the pharmaceutical industry. Automated quality inspection and production systems enable advanced quality control while simultaneously increasing pharmaceutical productivity and efficiency."

Aerial view of Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk [Photo by Lee Chunhee]

On the 25th, the Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk, lived up to its name as a 'smart factory,' with machines outnumbering people. At each process, only one or two people monitored the operations, and unlike other factories, it was rare to see people busily moving around to check the processes.

Completed in 2017 with a total investment of 210 billion KRW, the Osong Plant achieved Level 4 certification in the smart factory stages, which are divided into five levels. Given the high regulatory standards in the pharmaceutical industry, it is unusual to elevate a smart factory to Level 4. This level allows for preemptive responses and optimized decision-making through simulation, and if there are no errors or process changes, most processes require no human intervention. At the final Level 5, monitoring, control, and optimization become fully autonomous, with artificial intelligence (AI) capable of handling process changes and error responses in real time.

Lee Seungha, Head of Production at Daewoong Pharmaceutical and manager of the Osong Plant, emphasized, "The pharmaceutical industry directly impacts human life and health. We aim to become a factory that creates a super-gap in competitiveness by securing high-level quality competitiveness and cost manufacturing competitiveness through production systems that prevent human errors and real-time environmental and process monitoring systems."

To this end, the plant is equipped with necessary IT systems for factory operations, including Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Quality Management System (QMS), Warehouse Management System (WMS), Environmental Management System (EMS), and Building Management System (BMS). Notably, the LIMS was developed in-house by the subsidiary ids&Trust, tailored to the characteristics of the pharmaceutical industry.

Pill pharmaceuticals are being produced through an unmanned process at Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk.
[Photo by Daewoong Pharmaceutical]

The facility unveiled that day was Building A within the production complex of the Osong Plant, where Daewoong Pharmaceutical’s flagship product 'Urusa' and blockbuster candidates 'Enblo' and 'Pexuclu' are manufactured. Currently, the Osong Plant has two facilities: Building A for solid dosage forms and Building C for injectables. Building B, located in the middle, has completed groundwork and is planned for future expansion depending on market conditions.

Human intervention in the production process at Osong is minimal. Except for the initial raw material input stage, no direct human involvement occurs in the processes. Although management personnel continuously monitor the processes, the central control room is so reliable that no staff are permanently stationed there. Yoon Sangin, Manager of Production Management at the Osong Plant, emphasized, "A key feature of the Osong Plant is minimizing contact between products and people throughout the entire process from raw material receipt to product shipment." He added that even the only manual step, weighing, is strictly controlled by preset values to prevent errors.

Except for weighing, all raw materials and products move through the processes solely by robots and gravity. The processes?weighing, granulation, mixing, tableting, coating, sorting, packaging, and logistics?occur across four floors at different heights. Raw materials measured in the weighing room on the second floor are lifted to the third-floor supply room, then descend through the granulation room on the second floor and the mixing room on the first floor using a 'Vertical Transfer System (VTS)' that utilizes gravity. Subsequently, they are lifted to the third floor by an unmanned lift, pass through tableting and coating on the second floor, and are transferred to sorting, packaging, and logistics equipment on the first floor. This entire process is conducted through Intermediate Bulk Containers (IBC) called 'bins' and pipes, with horizontal movements handled by Laser Guided Vehicles (LGV), ensuring no human contact.

Sorting is also automated, with six cameras stereoscopically assessing the condition of pills to remove defective products. Manager Yoon explained, "In other factories, people still visually inspect and sort defective products. While training can improve accuracy, fatigue toward the end of shifts can reduce sorting quality. Our automated sorting system removes 100% of defective products." Additionally, various quality tests conducted per batch utilize LIMS and other systems to enhance inspection efficiency.

Even in the final packaging stage, no human work is involved. In factories where smart factory systems are not fully implemented, tasks such as manual plastic wrapping of boxes and pallet replacement are still performed by people. However, at the Osong Plant, these processes are fully automated. The challenging task of transferring products loaded on internally managed pallets to external shipment pallets is also easily and seamlessly handled using a 'pallet changer.'

Central Control Room of Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk. True to the concept of a smart factory, there are no personnel stationed in the control room under normal circumstances.
[Photo by Daewoong Pharmaceutical]

Through these efforts, the Osong Plant has achieved a 40% improvement in productivity indicators and over 30% reduction in cost ratio. It produces similar productivity with about 25% fewer personnel compared to Daewoong Pharmaceutical’s Hyangnam Plant. In terms of quality, the plant has maintained significant achievements, such as receiving a 'Zero Observation' decision during the recent manufacturing and quality inspection by Brazil’s National Health Surveillance Agency (ANVISA) for exports of Pexuclu and Enblo.

Center Head Lee Seungha stated, "In the long term, we aim to achieve Level 5, the highest smart factory level, at the Osong Plant and become a leading factory that sets the standard model for future pharmaceutical production plants." He highlighted the advantages of the smart factory, saying, "The ANVISA inspection was smoother because the Osong Plant’s system was recognized as one where falsification and data manipulation are impossible."