- Composition of rubber components
- Extractables and leachables from rubber
- Fine tuning of rubber composition to adapt to the rubber use
When a drug packaging is selected a particular attention is needed for the selection of rubber products. Indeed, a wrong choice of such products can lead to the compounds not performing according to the expectations, high amount of leachables or even incompatibility with the drug resulting in failed stability study.
Several topics will be discussed, starting from the rubber composition and its impact on extractables. Over the years, rubber formulation have changed to reduce the amount of products leaching from the rubber. This phenomenon can be further reduced by applying a coating on the rubber.
Finally, the rubber composition can be further tuned depending on the intentional used. For examples, rubber products for lyophilized drugs have been optimized for fast drying. Whereas rubber products for needle shield need to be permeable to EtO gas to ensure a sterilization of the drug packaging.
Simon Kervyn, Manager Materials Development, Datwyler