Production Plants and Logistics

Diagnostics and Culture Medium Production Plant (Yuki Plant)

Shimadzu Diagnostics established the Yuki Plant, a GMP (good-manufacturing practices) compliant pharmaceutical production facility, in 1976. We then added a diagnostics production facility in 1978, an R&D lab in 1982, and a logistics center in 1998, making the Yuki Plant site the central location for some of our most important facilities. Establishment of the Tsukuba Plant took place during two periods – one in 1993 and the other in 1999 - during which pharmaceutical and health food production facilities were built and brought on line. At the same time, the Yuki Plant was reconfigured to focus on extracorporeal diagnostic agents, bacteria and cell culture media, control serums, and other testing products.
By adopting cutting-edge systems and equipment that automate processes and reduce manpower requirements, we are enhancing quality control and building production systems capable of providing high-quality products in line with customer needs. In June 1995, we became the first pharmaceutical company in Japan to obtain the ISO9001 international quality management certification (excluding device products and introducing-devices bearing the name of the manufacturer) for immuno-serological testing agents, one of our main products. In 1999, we obtained ISO9001 certification for all of our diagnostic agent products as part of our effort to build a quality assurance system - one that would cover not only manufacturing but every process, starting at the development stage, and would satisfy global market demands. We followed this effort up by obtaining the ISO13485 international quality management system certification for medical devices (for extracorporeal diagnostic agents only; Registration number: JQA-MD0029) in July 2005 and the ISO14001 international environmental management system certification in March 2006.
To centrally manage information for all of our production plants and sales offices, we have constructed a companywide information network, with the host computer installed at the Yuki Plant.

Facility Overview

Safety is a prime concern for products^* used in regenerative medicine. Culture media are essential to the creation of these products and, therefore, must be made in line with rigorous quality standards to deliver the safety required. To meet customer expectations for quality and safety, Shimadzu Diagnostics employs a dedicated facility to produce culture media used for creating regenerative medicine products.

*In the Pharmaceutical Affairs Act, as amended in 2013, regenerative medicine products are defined as a product category apart from pharmaceuticals and medical devices. According to the amended law, a regenerative medicine product is: 1) Human or animal cells subjected to culturing or other processing for use in restoring, repairing, or creating bodily structures or functions, or for use in treating or preventing disease; or 2) A substance introduced into human cells for the purpose of performing gene therapy.

Description

1. Facility for producing safe, high-quality powdered and liquid culture media in accordance with raw material standards for regenerative medicine products.
2. Operations conducted under an ISO9001-compliant quality management system.
3. Manufacturing performed under clean-room-level conditions with strict controls on particles, microorganisms, and other airborne contaminants.

Facility Overview

Supply Chain Management Center

The Supply Chain Management Center concentrates on conducting logistics operations that respond immediately to market changes. Employing numerous examples of the most up-to-date equipment and systems, this facility has established a logistics system that operates at consistently high levels of quality and efficiency. In achieving its high level of performance, the Supply Chain Management Center has obtained the ISO9001 international quality management certification (excluding device products and introducing-devices bearing the name of the manufacturer), the ISO13485 international quality management system certification for medical devices (for extracorporeal diagnostic agents only; Registration number: JQA-MD0029), and, as of March 2006, the ISO14001 international environmental management system certification.

Facility Overview