Datwyler combiseals to reduce burden on pharma manufacturers

Altdorf, Switzerland - Elastomer products maker Datwyler is to introduce a range of 'ready-for-sterilisation' (RFS) combiseals for cartridges used in medical injection devices.

According to Datwyler, the RFS combiseals will take the burden off drug manufacturers, saving time and cost while complying with regulatory requirements.

Used in drugs administration devices, such as such as pens and autoinjectors, the combiseals are in direct contact with the drugs administered, the Swiss group noted 11 Oct.

Prior to arriving at a pharma manufacturer, the seals undergo Datwyler’s own 'water-for-injection' hygienic washing process.

They are then packed in steam sterilisable bags, which comply with the EU and FDA microbiological cleanliness requirements.

The service, projected to be introduced to Datwyler’s portfolio in 2024, will handle both washing and sterilisation steps in the production process.

The development, said Datwyler, will enable pharma companies to focus more on drugs manufacture, with the washing and sterilisation of rubber materials being done by the rubber manufacturer.

Pharma companies, it explained, will “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.”

Customers will also “benefit from 100% camera inspection and regulatory compliant washing program directly by having fewer visual defects, and fewer rejects on their production lines, the company added.

Furthermore, the washing validation information process will be filed in Datwyler’s ‘DMF’ so that customers can readily reference the same for drug submissions to the FDA by using RFS combiseals.