Masterbatch for medical products
With the development of the MAXITHEN® MEDICAL series, we have created a range of products for the medical technology sector characterised by the highest quality and offering low dosage and easy processing.
The requirements for products in the medical field are exceptionally high, which includes the consistently high quality of the raw materials. To meet these high requirements, we have the standards EN ISO 13485:2012 plus AC:2012 (Quality Management System for Medical Devices) and EN ISO 22000:2005 (Quality Management System for Food Safety).
Our MAXITHEN® MEDICAL series consists of a range of colour masterbatch for almost all production technologies as well as a wide range of applications, including the colouring of needle holders according to EN ISO 6009.
Needle holder according to ISO 6009
With our MAXITHEN® MED series, we offer a range of colour masterbatch for the colouring of needle holders. The colours comply with the international ISO 6009 standard that aims to enable the quick visual recognition of needle diameters for injections. The colours used for the identification of the needles are available as transparent or covering colours. The colour code correlates with normal, thin and extra-thin wall thicknesses of the needle.
Functional additives give important attributes to medical plastic devices.
1) Permanent Antistatic
Our product increases the conductivity of the polymer and reduces the negative partially charged state. The addition of this masterbatch, also available in transparent form, ensures safe handling and precise dosing of powdered pharmaceutical materials.
2) Laser marking
Our laser additive masterbatch allows non-contact, permanent marking or inscription of plastics. The laser technology is particularly suitable for UDI (Unique Device Identification) established by FDA as the label is chemically resistant, sterilisation-resistant and approved for direct contact with food, and at the same time does not change the properties of the marked product.
3) X-ray Tracer
For invasive procedures, the detectability of existing plastic items/products/objects is crucial. Plastic components are equipped so that they are recognisable by X-ray machines.
Lubricants reduce friction between the individual plastic components. If the syringe plunger glides easily and smoothly into the cylinder, this is not only more comfortable for the patient but also allows greater dosing precision
For the infrastructure of health facilities, we provide flame-retardant additives, which can of course be halogen-free if desired. Our flame-retardant masterbatch is designed in accordance with numerous international construction standards.
For process and quality control in the manufacturing process, our product range includes the innovative additive PROTEC. Moreover, it can be used to protect against plagiarism, with the originality of the product being confirmed or rejected by means of a sensor. In the area of Self Dosing products, safety in dosing and the correctness of the material used can be ensured through the use of Protec
Our expertise and market knowledge result from decades of experience in the medical field, thanks to which we are now in a position to meet almost all requirements in terms of colours and functional additives.
Thanks to our decades of experience in the production of masterbatch for medical products, we are amongst the market leaders in Europe in this segment. Our employees in Product Stewardship have extensive knowledge of product and raw materials and are familiar with country-specific regulations. The possibility of production at nine of our own locations in Europe gives our customers the guarantee of uninterrupted supply.