Datwyler, a leading provider of high-quality, system-critical elastomer components, announces the launch of Steam Sterilization for Ready-to-Use components. This service is applicable to non-coated and coated solutions like OmniFlex® stoppers for vials and NeoFlex™ plungers for prefilled 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 2 years after steam sterilization.
The sterilization 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 lyophilization applications. The steam-sterilized bags are packed in protective secondary packaging to avoid any damage during transport that could introduce contaminants. Additionally, a vacuum is 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 sterilization process will also be supported by a DMF filing in the US and Canada, allowing customers to request a Letter of Authorization to reference the DMF in support of regulatory filings.
The addition of Datwyler’s RTU Steam Sterilization option can be beneficial to smaller pharmaceutical manufacturers that have fewer resources to complete this step in-house. Other, larger pharmaceutical producers may benefit from outsourcing this process if they are focusing resources elsewhere—like vaccine development and trials—amid the COVID-19 pandemic.
