Rubber components for pharmaceutical processing and medical devices

About this product

AVK GUMMI develops, produces and sells rubber components for use in the manufacturing of medicine and care products as well as medical devices. Naturally, there are high demands on quality and know-how as well as regulatory compliance. We produce customised rubber components for a wide range of applications – from the most simple products for couplings for high precision micro components and gaskets with a thin film of PFA or other PTFE-like materials.

Why our rubber solutions are suitable for healthcare Rubber components for contact with skin or medicine are subject to enhanced requirements as a number of factors may affect the medical product or the skin and with that the safety of the consumer. Therefore, we have particular focus on the following factors: - Rubber for contact with skin must not cause allergic reactions or otherwise pose any form of health risk. - The rubber compound must not release substances that may affect the effectiveness or the shelf life of the medicine or create undesired degradation products. - The rubber compound must be suited for the function of the process equipment. The surface of the rubber component must be easy to clean and sterilise for the sake of the product quality and consumer safety. The rubber formulation must be resistant to cleaning agents, sterilisation and of course the product itself. - The properties of the rubber material must provide optimal functioning, e.g. minimum permanent deformation, which ensures leak-tight gaskets. High tensile strength ensures a long lifetime, and low friction reduces the closing torque, e.g. in a butterfly valve. This reduces the energy consumption when operating the valve.

Which type of rubber should you choose? This depends on the nature of the application. For instance, fluorosilicone would be a good choice for a microphone mount for a hearing aid due to the acoustic clamping characteristics of the material. In the case of a gasket for a processing plant, it must be considered if the product is soluble in water or fat, just as the cleaning system and working temperatures are important factors. Naturally, compliance is an important aspect; in which country will the component will be used, and in which markets will you launch the product?

The primary types of rubber in our healthcare programme are: - EPDM - HNBR - FKM - Silikone og Fluorsilikone - Polyisopren

Consumer safety in a global perspective If your company operates in multiple markets, you know all about the challenge of complying with the different legal requirements, recommendations and standards – and the burden that comes along with the obligations of documentation. At AVK GUMMI, we produce rubber components for healthcare based on compounds that comply with USP. Depending on your product, we will have In Vitro and In Vivo tests carried out – however, most of the tests are carried out In Vivo in accordance with USP <88> Class VI. The test procedure for rubber compounds used for medical equipment is somewhat different – these compounds are approved for each specific purpose. Together, we define the approval requirements, generate the required documentation and obtain the necessary approvals. Typically, an approval of the equipment is required. This often consists of several components from independent sub-suppliers. Therefore, normally you will be the one to submit the application, supported by our material approvals. We send our rubber formulations and test samples to independent, accredited test institutes for testing. This list shows a selection of the many standards fulfilled by rubber compounds from AVK GUMMI: - USP <87> - USP <88> Class VI - ISO 10993-5