Producing consistent, quality products in a cost-efficient manner with fast cycle times; this is the challenge facing the medical device manufacturer of high volume, disposable devices. ELASTO are helping customers achieve this with the development of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes.
The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimize plunger movement for accurate dosage control and ease of injection.
The Mediprene materials are latex free, which reduces the risk of allergic reactions. Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI. ELASTO offer these grades as translucent or coloured compounds, made from medical grade raw materials. The colour masterbatch supplier has been selected with care, ensuring that not only the pigments and carriers are compliant but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control thereby fitting the Mediprene concept at ELASTO’s ISO 13485 accredited facilities.
Alongside their material advantages, because of the cost and speed at which they can be manufactured, Mediprene TPEs are being specified as an alternative to thermoset rubber. They require no vulcanisation and are 100% recyclable. Fewer process steps without the need for additional operations such as trimming means less energy is used and production is faster and more cost-efficient. TPEs have a lower specific gravity compared to several alternative materials, you can therefore not only create lighter-weight parts, but you can also produce more parts per kilogram of material.
Niklas Ottosson, medical technical manager at ELASTO commented “We are happy to introduce our new grades for plunger seals, Mediprene 500584M (translucent) and Mediprene 502584M (black), on the market. With these grades as starting points, we will continue to engineer intelligent solutions which precisely fit customer part design and specific requirements.”