Datwyler adds steam sterilisation for ready-to-use components
Datwyler, a provider of high-quality, system-critical elastomer components, launches its Steam Sterilization for Ready-to-Use components.
Key highlights:
- Datwyler has expanded its portfolio with its RTU Steam Sterilization option for smaller pharmaceutical manufacturers that have fewer resources to complete this step in-house.
- 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.
This service is applicable to non-coated and coated solutions like OmniFlex stoppers for vials and NeoFlexä 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 sterilisation.
“We wanted to expand our portfolio with a RTU Steam Sterilization option that truly caters to the needs of biopharmaceutical packagers and manufacturers,” Carina Van Eester, global platform leader PFS and cartridges said. “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.”
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 sterilied 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 Sterilization option can be especially helpful 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.