Efforts to Enhance Product Safety

Water is the lifeblood of all ophthalmic solutions. Water of the highest purity is necessary not only to ensure medical safety, but to maintain quality as well. In the course of producing our prescription and over-the-counter ophthalmic pharmaceuticals, Santen only uses water that has been subject to a series of purification steps including physical processing, chemical processing, ion-exchange treatment, ultrafiltration(*1) and distillation. The purity of the water we use meets the exceptionally strict standards stipulated by the Good Manufacturing Practice (GMP)(*2) for water-for-injection products. Our focus on attaining the highest level of quality is also exemplified by how we use purified water to clean and sterilize our manufacturing facilities including solution tanks, pipes connecting production lines and other types of equipment.

The Japanese Pharmacopoeia(*3) normally classifies ophthalmic pharmaceuticals as sterile products. Santen strongly believes our production plants should be held to the same environmental control as those for operating rooms. In other words, because our products need to be sterile beyond reproach we are committed to doing whatever it takes to prevent bacterial contamination. All of our domestic and overseas plants implement rigorous climate measures such as optimal zoning of cleanrooms and intensive management of indoor pressure and air flow. Operational areas are divided into the smallest units possible and air quality controls are precisely designed and adjusted according to the contamination risk thresholds for each unit. Air quality is monitored at all times and as a result the number of airborne particles of 0.5µm or larger is 353,000 or less per square meter during non-operating hours and 3.53 million or less per square meter during operating hours. This level of air quality is equivalent to Grade C under the GMP for Manufacture of Sterile Medicinal Products. Furthermore, because the filling zone requires the highest cleanliness level of sterility, the air quality there is equivalent to Grade A, the level mandated for operating rooms.

Santen’s manufacturing lines feature Japan’s largest production capacity in the industry and a quality standard that precisely meets the requirements of Good Manufacturing Practice (GMP). Although Santen constantly supplies quality-assured items produced on these lines, we believe even perfect manufacturing lines cannot create products that truly satisfy patients if they are not operated by highly motivated workers. Santen believes the key element in pharmaceutical production is the line operators’ motivation and enthusiasm to help patients. Every operator must be aware of the significance of each individual step in the manufacturing process in helping patients. Operators must be fully aware of the potential impact on patients of any problem in any part of the process, and work to resolve problems for the sake of patients. Santen believes that it is its essential mission to foster operators’ ability and skills to address any problem in the manufacturing process in a timely manner, as well as their sense of responsibility to act for patients, constantly remembering their needs.