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Compounded PROVAMED® TPE
Seals for medicine and pharmaceuticals need to comply with various and extremely demanding tasks considering that they are used in critical components and processes such as in therapeutic, diagnostic equipment or in infusion devices.
Sterilizability as well as resistance to chemicals and media are other characteristics to be taken into consideration.
By applying the corresponding level of care, PROVAMED¨ TPE are exclusively compounded from raw materials approved for medical applications and subject to strict selection criteria. This material quality means that products thus manufactured pass the decisive medical tests.
Apart from caoutchouc, the material of choice in the past was often silicon as it was regarded as being generally compatible. Nowadays, increasing miniaturization means that processing often represents a challenge even for experienced injection-molding experts. And there is much to be said for using TPE which are comparably easy to process as they contain a very low percentage of emitable substances, are recyclable and cost-effective, and display very good sealing and adhesion properties.
Disposable syringes are usually packed individually and sterilized. Sterilization often takes the form of gamma radiation. For many plastics, impingement by this highly-energetic radiation represents a major challenge. Embrittlement, discoloration and in some cases extreme changes in terms of mechanical properties can be the result. These effects need to be taken into consideration as early as the formulation stage for the TPE recipe. The fact that PROVAMED¨ TPE are suitable, especially for technical medical applications requiring sterilization of the end product, has been proven by numerous tests prior to and after deployment of the various sterilization methods. Even after a high dose (50kGy) of gamma radiation or autoclaving at 134 °C, hardly any changes were detected in terms of mechanical properties and the values were close to the respective original tensile strength value.
PROVAMED¨ TPE can be adapted to a wide variety of customized requirement profiles. They also offer a particularly good degree of adhesion to thermoplastics such as PE, PP, PS, ABS, PC and PA, which is also maintained even with continuous contact with media and at increased temperatures. Furthermore, they are free of PVC, phthalates, silicon and latex, which means they are also free of allergens.
The modern rubber pacifier was developed in the second half of the 19th century while today’s standard palatal form was designed by the dentist Adolf Müller in 1949. Apart from pacifiers and bottle teats, special pacifiers are also used today as teat trainers in therapy for weak babies, malfunctions in mouth motor activity, and in speech therapy. ACTEGA DS offers compounded PROVAMED¨ TPE for these applications for the special requirements of baby items which are also free of PAH, thereby complying with the (EU) Directive No. 1272/2013 which specifies binding limit values for PAH. It goes without saying that they are also free of BPA as well as being thermally stable. Furthermore, they are particularly suitable for adhesive compounds with standard thermoplastics such as polyolefins and display an outstanding degree of transparency.
TPE display a special mechanical performance. Even after 200% elongation, the compounds offered in Shore hardnesses of A-40 to A-50 reveal deformation of only maximum 20 percent. Tensile strength is greater than nine at 800 percent elongation at break. The fact that the material is bite-resistant is also of major significance. By choosing TPE with a high degree of bite-resistance, the highest demands on safety are complied with. The most important boiling test indicated that even when boiled several times, mechanical values underwent changes of ± 10 percent. And finally, migration tests - using 50 percent ethanol - were also concluded extremely successfully. This is an important point as the teat attached to a drinking bottle comes into contact with milk. The major advantage over silicon which is often used in baby pacifiers lies in its more attractive price level, recyclability, and the possibility of cost-efficient processing.
We will be presenting these and other applications at the K-Fair in Düsseldorf from October 16-23, 2019 in Hall 8A, Stand F 11-3.
Please contact us for information on other applications.