Datwyler, a provider of high-quality, system-critical elastomer components, launched its ready-for-sterilization (RFS) combiseals for cartridges used in injection devices such as pens and autoinjectors. As combiseals are in direct contact with the drugs administered, they are required to be clean enough to comply with regulatory requirements and prevent any risk to patients. The pharmaceutical companies receive a product with a controlled state of microbiological cleanliness, as the combiseals are furthermore packed in an environment with a defined and controlled state of cleanliness, complying with FDA and EU requirements.

Prior to arriving at the sterile drug manufacturer, the RFS combiseals undergo Datwyler’s own Water-for-Injection washing process and are packed in steam sterilizable (RFS) bags to ensure a controlled state of microbiological cleanliness that complies with FDA and EU requirements. This enables immediate sterilization of the combiseals.

The 100% camera inspection and regulatory compliant washing program provides fewer visual defects, and fewer rejects on their production lines. The washing validation information process will be filed in Datwyler’s DMF so that customers can reference the same for drug submissions to the FDA by using RFS combiseals.

The company also began working on another advancement,  ready-to-use (RTU) combiseals to further minimize the work of drug manufacturers. The service, projected to be introduced to Datwyler’s portfolio in 2024, will handle both washing and sterilization steps in the production process.

“In general, there is a trend that pharma companies want to focus mainly on their core activities – drug manufacturing,” said Carina Van Eester, global platform leader, prefilled syringes, and cartridges, at Datwyler. “Washing and sterilization of rubber materials is more and more done by the rubber manufacturers. Combiseals are the final product in our portfolio to supply in RFS format. Bringing value for our customers has always been a guiding force behind Datwyler’s overall philosophy. Our RFS combiseal offering is a natural result of that philosophy and Datwyler’s devotion to serving its customers’ needs.”