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Establishing high-tech facilities and manufacturing environments is essential but not sufficient. There still remains the challenge of maintaining reliability and safety. This is a challenge because reliability and safety involves not only physical structures but also a strong sense of responsibility on the part of every employee working at our plants. At Nipro Pharma, every one of our workers thoroughly understands the significant role our products play in society, and therefore never forget they must do their best to constantly ensure reliability and safety. The sum of all of our employees’ efforts in this pursuit takes cleanliness at Nipro Pharma to another level.
Complete Pursuit of Reliability and Safety
We take measures to quarantine our completely segregated production lines for advanced pharmacologically active agents.
Our Odate Plant recently began operations of a new steroid wing and new penem wing where we have taken strict measures to quarantine these completely segregated production lines for advanced pharmacologically active agents. For example, the wing where double-bags with penicillin antibiotics are produced is entirely isolated and will never be used to make any other type of product. Each wing has its own locker room and dining hall for employees who remain in their designated wings from the beginning to the end of their workday. Employees wear color-coded work outfits, another way we ensure complete segregation of our production lines.
One of the largest aseptic production facilities in Japan
Our production system features one of the largest total areas of isolators※ in Japan and is operated under extremely strict sterile compounding standards.
Needless to say, we manufacture our widely sold liquid/powder double bags under the most rigorous GMP quality control standards possible. However, we also actively use isolators for powder filling procedures and other operations where we have voluntarily determined that a higher level of sterility is required. In addition to maintaining an aseptic environment with the use of isolators, we have also adopted blow fill seal technology at our Ise Plant for integrated aseptic production spanning a wide range of procedures from plastic container molding to solution filling. These are just some examples of how Nipro Pharma has earned a reputation of operating an impressive production system in one of the ten most aseptic manufacturing facilities in the world.
※What is an isolator?
An isolator is an aseptic, dust-free facility used in drug manufacturing lines. A highly sterile environment is maintained in a stainless-steel chamber and
technicians handle objects within the chamber only with special integrated gloves. Isolators can offer aseptic environments superior to those of dust-free cleanrooms and are a means of achieving highly economic and efficient quality control in terms of preventing contamination.
Isolator
(Odate/Ise Plants)
