03.22.16
Vetter, a global contract development and manufacturing organization ( CDMO ) for the development, commercial manufacturing and final packaging of aseptically prefilled drug-delivery systems, has unveiled plans for the construction of a new building at a ground breaking ceremony held at its Ravensburg Schuetzenstrasse site. Scheduled for completion in the first quarter of 2018, the building is planned to begin operations in early 2019. Expected to cost approximately €70 million ($79 million), it is part of the total investment strategy announced by the company in September 2015, and will constitute an important element in the overall Schuetzenstrasse facility rebuilding concept for modernization and expansion.
Upon completion, the seven-story building will cover a total of 8,000 sq. meters (86,000 sq. ft), and include in its core a Cleanroom with supportive media systems. Additionally, it will contain the site’s central material preparation; office space for the production staff as well as a staff canteen with roof garden.
The applied technology of the cleanroom will be dedicated to the filling of bulk syringes and designed to be compatible for the filling of sensitive drugs such as biologics and opthalmics. Syringes prepared in the bulk process offer a number of customization options that are tailored to substance and Primary Packaging material components, and offer customizable low silicone levels and thus, process flexibility. Another central technological element of the cleanroom will be the implementation of an improved restricted access barrier system (RABS) concept to combine the advantages of isolator and RABS technology. The core of this innovative approach is a uniquely fast, by today’s standards, 3-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2).
“This addition to our Schuetzenstrasse site is an exciting chapter in our company’s history and will again support Vetter’s target to offer its customers the adequate high manufacturing quality for their high value drugs,” said Thomas Otto, managing director, Vetter. “Attaining this high level of quality is of particular significance to Vetter as it represents one of our core customer relations value propositions.”
Upon completion, the seven-story building will cover a total of 8,000 sq. meters (86,000 sq. ft), and include in its core a Cleanroom with supportive media systems. Additionally, it will contain the site’s central material preparation; office space for the production staff as well as a staff canteen with roof garden.
The applied technology of the cleanroom will be dedicated to the filling of bulk syringes and designed to be compatible for the filling of sensitive drugs such as biologics and opthalmics. Syringes prepared in the bulk process offer a number of customization options that are tailored to substance and Primary Packaging material components, and offer customizable low silicone levels and thus, process flexibility. Another central technological element of the cleanroom will be the implementation of an improved restricted access barrier system (RABS) concept to combine the advantages of isolator and RABS technology. The core of this innovative approach is a uniquely fast, by today’s standards, 3-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2).
“This addition to our Schuetzenstrasse site is an exciting chapter in our company’s history and will again support Vetter’s target to offer its customers the adequate high manufacturing quality for their high value drugs,” said Thomas Otto, managing director, Vetter. “Attaining this high level of quality is of particular significance to Vetter as it represents one of our core customer relations value propositions.”
