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 lyophilisation applications. The steam-sterilised bags are packed in a protective secondary packaging to avoid any damage during transport that could introduce contaminants. Additionally, there is a vacuum applied between the two sealed outer bags which is an indicator to assess packaging integrity at the point of use. RTU batches are accompanied by a Certificate of Analysis guaranteeing sterility. The steam sterilisation process will also be supported by a DMF filing in the US and Canada, which allows customers to request a Letter of Authorisation to reference the DMF in support of regulatory filings.
The addition of Datwyler’s RTU steam sterilisation option can be especially helpful to smaller pharma manufacturers that have fewer resources to complete this step in-house. Other larger pharma producers may benefit from outsourcing this process if they are focussing resources elsewhere—like vaccine development and trials—amid the COVID-19 pandemic, the statement concluded.
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