Commitment to Quality and Safety to Meet Medical Needs for Patients Worldwide

As a company specializing in ophthalmology and human eye health, Santen strives to deliver Happiness with Vision to people worldwide, leveraging the strengths it has cultivated for more than 130 years.
The number of people with eye conditions and diseases is expected to increase due to factors such as global population growth, the aging of the population and changing lifestyles. To steadily supply products of high quality and safety to patients with eye problems, Santen has built a production network based on the three locations in Noto and Shiga in Japan, and Suzhou in China, to meet medical needs from a patient-centered viewpoint in more than 60 countries and regions around the world.
This story focuses on the aspects of production and supply of our products that are delivered to patients, with some examples of our commitment to quality and safety and what we do to keep supplying products on a stable basis.

To ensure that patients can continue their treatment with confidence in safety, we manufacture our products to our own standards and specifications, which are even stricter than regulatory requirements. For example, since ophthalmic solutions must be sterile according to the pharmacopeia, we pay full attention to the “water” we use as a raw material, the “air” in our production lines, and the “people” who manage the processes to manufacture high quality products. We use water with a level of purity equivalent to that used in injections; containers are filled in a Grade A1(*1) cleanroom; and to maintain a high level of quality control, we have an internal qualification system to allow only qualified employees to be operators in charge of processes

1. Fewer than 100 particles of 0.5 μm or larger per cubic meter of air

To achieve stable supply of products to countries around the world according to each country’s medical needs, Santen has established specialized equipment maintenance teams. These teams minimize problems and ensure steady plant operation, thereby supporting a production and supply system capable of round-the-clock manufacturing. To minimize production line and equipment breakdowns and problems, we operate an equipment management system and conduct daily planned maintenance. In the event of a breakdown or problem, the personnel in charge promptly carry out repairs. This enables us to maintain product quality and prevent any negative impact on the manufacturing plan.

In cleanrooms for manufacturing ophthalmic solutions, maintenance is performed only by employees who have obtained a sterile maintenance qualification for facility upkeep. These employees acquire knowledge that encompasses not only keeping equipment in good condition, but also maintaining and managing a sterile environment, as well as wide-ranging specialized knowledge in areas such as acting in accordance with guidelines for manufacturing sterile medicines using aseptic operating procedures.

The proper maintenance and management of equipment requires a high level of expertise and technical skill. If a problem occurs at night or on a non-business day, the manufacturer of a device cannot usually be contacted. To respond appropriately, maintenance personnel make full use of their experience and expertise. They make themselves thoroughly familiar with equipment and engage in discussions with manufacturers to collaborate in building better equipment. In addition, they emphasize communication with manufacturing sites on topics such as enhancing operating stability and usability upgrades. With their strong sense of a mission to achieve sustainable and stable supply to patients, our maintenance staff support quality assurance and stable product supply.

Now, what do you think about these examples of our commitment to manufacturing and quality and efforts at our production sites? We at Santen believe that pursuing thorough control of process and quality and a stable supply system enables us to meet patient expectations, which leads to continued treatment. In order to solve social issues related to eyes for as many patients as possible, we are further strengthening our quality assurance system and improving our supply system. These endeavors of Santen continue as it aspires to be a Social Innovator to deliver happiness through vision.

Please visit our website and see “Efforts to Enhance Product Safety”, “Production” and “The Ophthalmic Production Process: Production” if you would like to learn more