Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has officially started construction of a new production facility at its Wertheim site, Germany with a groundbreaking ceremony.
By mid 2027, high-quality ready-to-fill (RTF/RTU) vials are expected to roll off the production line in a new 4,000 m² production hall in the innovative EZ-fill Smart packaging platform. At its Wertheim site, Gerresheimer employs around 160 people to produce injection vials and ampoules. The planned expansion is expected to create a further 50 jobs for skilled workers from the region. Wertheim will be the second Gerresheimer production site, alongside Querétaro, Mexico, to offer RTF vials in the innovative EZ-fill Smart packaging platform.
Gerresheimer is investing a total of around EUR 30 million in the construction and technical equipment of the new production building. The expansion underlines Gerresheimer’s position as a leading system and solution provider to the pharma and biotech industry, especially for injectable biopharmaceuticals.
“The expansion in Wertheim is an example of how we are implementing our growth strategy by expanding our portfolio with specialized systems and solutions for biopharmaceuticals,” explains Dietmar Siemssen, CEO of Gerresheimer AG.
“EZ-fill Smart is the next-generation packaging platform for ready-to-fill vials. Together with our Gx Elite RTF Vials, this high-value solution delivers optimal product quality and the best possible protection for sensitive biopharmaceuticals”, adds Volker Rekowski, Senior Vice President Europe & Asia Tubular Glass at Gerresheimer.
Center of excellence for vials and ampoules
The Wertheim site, which has been producing pharmaceutical ampoules since 1957, has been part of the Gerresheimer Group since 1989. It is Gerresheimer’s European Center of Excellence for high-value Gx Elite vials and ampoules, and in the future also for pre-sterilized “ready-to-fill” (RTF) vials. The last investment at the site was made in 2022 in new production lines for Gx Elite vials. The injection vials of the “Elite” performance level are characterized by very high break resistance, precisely maintained tolerances, and maximum surface quality. After about two years of planning, a state-of-the-art production infrastructure for RTF/RTU vials is now being built in Wertheim. The RTF/RTU vial market is expected to grow at a compound annual growth rate of around 13% until 20301.
EZ-fill Smart for best possible protection and efficient filling
With the new production hall, the Gx Elite Vials manufactured at the Wertheim Site will also be available as pre-sterilized “ready-to-fill” (RTF/RTU) versions in the EZ-fill Smart packaging platform. EZ-fill Smart is the next-generation packaging platform for RTF vials. Advantages include even less particles and, in the future, the possibility to use vaporized hydrogen peroxide (VHP) as an alternative, environmentally friendly and resource-saving sterilization method. EZ-fill Smart is compatible with all standard fill & finish lines, enabling flexible, safe, and cost-efficient filling processes. Combined with Gx Elite vials, EZ-fill Smart ensures highest protection for sensitive and expensive drugs such as novel biologics.
GMP Class C cleanroom
The RTF processing and packaging of the vials in the EZ-fill Smart format is planned to take place in the new production hall in an approximately 800 m² GMP Class C clean room (GMP = Good Manufacturing Practice). The new production infrastructure will thus meet the highest pharmaceutical requirements, as specified, for example, in Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products in the EU.
Energy efficiency and sustainability
The planned new building combines energy efficiency and sustainability in both construction and its technical systems. A 175 kWp photovoltaic system will be installed on the roof of the new building, with the remaining surface being greened. The entire power supply will come from 100% renewable sources.
Around 50 new jobs for professionals from the region
In the first expansion phase, around 50 new jobs for skilled workers from the region will be created by 2028. The production capacity for RTF/RTU vials in the new production hall can be further increased in the coming years.