GMP facility will manufacture elastomer components for injectable drug delivery systems with cleanroom technology
Swiss-based supplier for drug packaging and medical devices, Datwyler, is channelling more than $100m into building a new plant in Delaware.
The plant will run in accordance with Datwyler’s most advanced standard, First Line. It will produce the company's specialisms: elastomer formulations, coatings, aluminium seals and processing technologies.
The First Line production standard is specially designed to manufacture pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment.
The new facility will be used to manufacture high-quality elastomer components for injectable drug delivery systems. Production is scheduled to start in 2018.
Once up and running, the largely automated plant will provide jobs for around 120 employees. This investment will enable Datwyler to better provide customers in the US, Europe and Asia with locally produced components.
The First Line standard is a manufacturing concept for elastomer components based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection and a unique validated washing process.
This approach is certified to ISO 15378 and “exceeds the most stringent quality standards of the European and US regulatory authorities,” according to the company.
Datwyler has developed three different offering categories: