OR WAIT null SECS
These components take the burden off drug manufacturers to prep packaging components for sterilization, while helping to enhance the drug filling and packaging process.
Datwyler, a provider of elastomer components, has launched its ready-for-sterilization (RFS) combiseals for cartridges, which are used in injection devices such as pens and autoinjectors. As combiseals are in direct contact with the drugs administered, they must be clean enough to comply with regulatory requirements and prevent any risk to patients.
Before 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 allows for immediate sterilization of the combiseals.
“In general, there is a trend that pharma companies want to focus mainly on their core activities: drug manufacturing. Washing and sterilization of rubber materials is more and more done by the rubber manufacturers,” says Carina Van Eester, global platform leader, prefilled syringes and cartridges, Datwyler. “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.”