Datwyler adds steam sterilisation option for ready-to-use components for injectable drugs
Datwyler will deliver RTU components in robust packaging guaranteeing a shelf life of two years after steam sterilisation
Datwyler has launched steam sterilisation for ready-to-use components. This service is applicable to non-coated and coated solutions like OmniFlex stoppers for vials and NeoFlex plungers for pre-filled syringes and cartridges. As part of the company’s ‘quality first’ approach to designing and producing these packaging components, Datwyler will deliver RTU components in robust packaging guaranteeing a shelf life of two years after steam sterilisation.
“We wanted to expand our portfolio with a RTU steam sterilisation option that truly caters to the needs of biopharmaceutical packagers and manufacturers. Offering steam sterilisation besides gamma irradiation provides a choice to the customer which allows them to select the sterilisation technology they prefer in function of the application,” Carina Van Eester, Global Platform Leader, PFS and Cartridges, said, in a statement issued by Datwyler.
The statement further said that the sterilisation cycle guarantees that a Sterility Assurance Level (SAL) of at least 10-6 is obtained. Special attention is given to the drying cycle to reduce post-treatment moisture to levels acceptable for even lyo