Meet the “Craftsmen”
Supporting Santen’s Quality Culture

When it comes to the production of sterile (aseptic) eye drops, the presence of bacteria is strictly prohibited. For this reason, we pay close attention to air management, and only trained and certified workers are engaged in the production of sterile products. In the filling zone, we maintain a Grade A air cleanliness level, equivalent to a surgical operating room.

Furthermore, in order to comply with established product standards, meticulous adjustment and careful maintenance of dispensing and filling machines is essential because even the slightest distortion during installation of a single component can affect the quality of the product. With multiple lines operating simultaneously, we must be able to quickly and calmly determine the status of each machine, the cause of the problem, and the best course of action. Assessment and response tend to be based on the tacit knowledge of each individual, who draws on their experience and intuition. However, maintaining a stable supply of high-quality products demands that everyone is working from the same playbook; as such, “visualizing” tacit knowledge and skills and making it available to others as formal knowledge is critically important.

Our goal is to make the setting up and post-maintenance verification process procedural and quantifiable so that everyone on the team can achieve a high level of operational excellence.

The packaging process includes wrapping with shrink labels (plastic labels that shrink when heated), printing expiration dates and other information, the inner box and accompanying documents, and the outer box. Each step in the packaging process requires high-quality operations at production speed. This is made possible through a combination of innovative manufacturing machinery and skillful and knowledgeable operators.

The malfunction of a single part can render a complex machine inoperable. To reliably produce the planned quantity of products on a daily basis, we must pay close attention to every detail on the line, anticipate issues, and think ahead—for example, “This part will need to be replaced soon, so let's place an order for it now.” The production line operates 24 hours a day, and there are times when we have to resolve problems on our own—such as late at night when outside support is not available. We make an effort to pass on our expertise by taking the entire team on site to improve their knowledge and skills.

We will continue to manage the daily production process with pride knowing that the technologies we have developed and refined are responsible for supporting the stable supply of high-quality products that directly contribute to patients.

Santen’s plant on the Noto Peninsula was damaged by an earthquake in January 2024. Employees in Noto were also affected by the earthquake, but quickly assessed the damage and formulated a recovery plan, driven by their mission to support the stable supply of products.

While placing the highest priority on employee safety, employees worked diligently to resume production so that by the end of March, most of the production lines were back in operation. Such a quick recovery was only made possible by their deep sense of responsibility for production. By the end of September 2024, full restoration will have been achieved following verification in accordance with GMP standards.