ACTEGA DS GmbH

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. As a general rule, materials must correspond with the specifications of the U.S. Food and Drugs Administration as well as the USP Class VI Standards. They need to be tested for biocompatibility (ISO 10993) and physiological safety as well as guarantee the material’s compatibility with the human organism if there is direct contact between the material/product and patient. 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.

A syringe – for administering medication (injections), drawing body fluids (puncture) or tissue (biopsy), infusing fluids and nutrients as well as for irrigating wounds – comprises a cylindrical cavity containing a mobile piston, a conical or cylindrical nozzle, and a seal mounted at the end of the piston. By the way, the first syringe for administering liquid medication – so-called injectables – was developed by a Frenchman, Charles-Gabriel Pravaz, in 1841. While the disposable syringe bodies are usually made of polypropylene or cycloolefin copolymer plastic, the seals are based on rubber, caoutchouc, silicon or TPE. A variety of demands are made of these seals.

Leakproof closure of the syringe body, support of the piston movement for precise administration, user friendliness and patient welfare, to name but a few. Apart from function, sterility and low-migration properties, the material must also meet the requirements of the EN ISO 7886 standard (for disposable syringes) establishing its gliding properties, tightness and mechanics. The connector on a catheter coupling must be capable of withstanding specified tensile forces on the one hand but must not be crimped or otherwise damaged on the other.

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.

PVC is still used in the vast majority of these devices, but there has been a concerted effort over the years to move away from this material because of perceived health concerns. TPEs are a safe bet, according to Actega, especially in this application.

•  TPE for medical drip chambers of IV sets

Avoiding chemical food contamination: The safe alternative for protecting baby food