Continuous verification
ensures performance above standards.

From Raw Materials to Products

Tests and inspections : Tests and inspections for quality control apply to all stages, ranging from the acceptance stage of raw and other materials (e.g., containers, packages, and attached datasheets) to the manufacturing stage of a wide variety of products. These tests and inspections vary with each type of product. Therefore, analytic objects, techniques, and testing machines in a wide range are used. All the tests and inspections are conducted strictly. The production lines will not work unless the requirements of the tests and inspections are satisfied, and shipments will be permitted only if the products pass all the tests and inspections.

Testing Laboratory

Testing machines : Nitto Medic has substantial inspection systems, such as high performance liquid chromatograph (HPLC), gas chromatograph, and spectrum photometer systems. Nitto Medic's experienced staff members conduct a huge number of test and inspection items to maintain the high quality of products and the required time for product delivery. The staff members support stability tests, and check and guarantee the quality of products after shipment.
Sterility test : Nitto Medic's sterility tests are conducted in a sterile environment at the highest level, where only staff members in charge of tests can enter. Microbe tests are conducted on raw materials, containers medical fluids, product, etc. to ensure that they are all sterilized.

Clears the world's standards

Manufacturing environment : The formulation area is divided into a number of zones on a process basis, and the cleanliness level of each zone is under air-conditioning control while environmental monitoring is conducted to make microbe and particulate checks. The manufacturing space of The Third Preparation Building is classified into six grades for stricter environment management. This building meets the GMP standards in Japan as well as world-level manufacturing standards specified by the Food and Drug Administration (FDA). Nitto Medic is aiming at further improvements in all the area to clear the world's standards in the future.