We have applied our expertise in ready-for-sterilization (RFS) solutions to a platform of ready-to-use (RTU) components. In doing so, we bring a comprehensive solution to our customers and take full responsibility and ownership of the sterilization of the products prior to their shipment. This adds value to our customers who consequently can focus their resources to their core business — the manufacturing and filling of drug products.
Process efficiency and total cost management.
At Datwyler, we offer a wide variety of sterile products ready for immediate use. RTU components simplify stock management and operational planning. They also create faster lead times and reduce risk and labor costs through increased efficiency, flexibility, and security of supply chain. Sterilized and vacuum packed, all RTU rubber closures can be deployed immediately in aseptic filling operations. Additionally, the vacuum packaging between the outer bags makes it easy to check for sterility at the point of use.
This validated RTU concept eliminates the need for washing, siliconization, sterilization, (re)validation of equipment, and quality assurance checks of work in progress. The use of RTU components significantly reduces capital investment, manufacturing/labor costs, downtime, and floor space.
Improved safety and reliability.
Datwyler RTU solutions satisfy the strict requirements of the pharmaceutical and biotech industry meeting EP, USP, and JP requirements. They also comply with the latest FDA regulatory guidelines.
Answering the evolving requirements of pharmaceutical filling operations and more stringent regulatory guidelines, RTU products are also available in combination with Rapid Transfer Port (RTP) bags. By minimizing human intervention in the component transfer process, the risk of contamination is significantly reduced. In addition, the operational efficiency gets increased by facilitating routine operations.
Sterilization capabilities to meet the customers’ drug product needs.
Datwyler products are compatible with all standard sterilization methods on the market, making it easier for customers to source components for their specific drug applications. Steam and gamma sterilization are equally viable options for most Datwyler components, allowing our customers to meet their sterilization requirements.
Our team of experts provides the appropriate data and technical support necessary to enable our customers to select the right sterilization method for their drug product.
- Final product requirements analysis
Using a consultative approach, we gather details on the customers' final product requirements and characteristics. - Process knowledge and pro/con evaluation
Leveraging our decades of experience, we have developed a holistic approach that considers all critical aspects. - Providing data packages on request
We can provide an array of data packages detailing the compatibility of drug products and compounds before and after steam and gamma sterilization.
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