There is a high requirement for all kinds of pharmaceutical stoppers including connectors, vale membranes, seal membranes etc in the pharmaceutical industry. Therefore the self-sealing characteristics of the material used in the stopper and the ease in which it can be sterilised without a change in its mechanical properties is vital.
ProvaMed 6145 TL, 6245 NC and 6345 NC, one transparent and two natural-coloured variants of thermoplastic elastomers (TPE) compounds are available for pharmaceutical closures, their performance and conformity comply with USP 381 and also fulfil all standard sterilisation methods.
USP chapter 381 defines standards for the functionality testing of closures intended to be pierced by a hypodermic size 21 gauge needle to include: penetrability, fragmentation and self-sealing capacity as well as biological and physiochemical tests.
One of the main requirements of complying with this standard for pharmaceutical closures is that the material can be closed again immediately and fully after piercing. Even after multiple piercing, the container must remain entirely safe and leak-proof in order to prevent contamination of the active agent.
The ProvaMed TPE offered by Actega DS passed all tests in accordance with USP 381 and offers many benefits including simple processing, cost-efficiency, lower waste during production and recyclability.
ProvaMed has outstanding self-sealing properties for safe reclosure even after multiple piercing, this not only extends the useful life of the closure and minimises the risk of contamination, it also increases patient safety. Even after multiple punctures, no fragmentation and no particle residue remains on the needle.
Methods of sterilisation including steam, gamma radiation and ethylene oxide were tested on the product. The tests indicated no significant changes in the properties of the ProvaMed material.
With a very low migration potential and dispensing with PVC and plasticisers, these TPE products present a clean solution for manufacturing plugs and closures in injection moulding.
Actega DS presents at Fakuma, Friedrichshafen, 17–21 October 2017, stand B5-5210, hall.
