Datwyler Adds Steam Sterilization Option For Ready-To-Use Components For Injectable Drugs

Datwyler will deliver RTU components in robust packaging guaranteeing a shelf life of 2 years after steam sterilization

Middletown, DE —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 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 sterilization.

“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 sterilization besides gamma irradiation provides a choice to the customer which allows them to select the sterilization technology they prefer in function of the application.”

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 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 sterilization process will also be supported by a DMF filing in the US and Canada which allows 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 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.

To learn more about Datwyler’s RTU Steam Sterilization option, visit https://datwyler.com/healthcare-solutions/healthcare

DATWYLER | HEALTHCARE

Datwyler is focusing on high-quality, system-critical elastomer components and has leading positions in attractive global markets such as healthcare, mobility, oil & gas, and food & beverage. With its recognized core competencies and technological leadership, the company delivers added value to customers in the markets served. With more than 20 operating companies, sales in over 100 countries and more than 7,000 employees Datwyler generates annual sales of more than CHF 1’000 million. Within the healthcare solutions business area, Datwyler develops, designs, and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future! www.datwyler.com