Cost-effective mobile therapy systems are becoming increasingly popular as a result of rising cost pressures in the health service and the growing number of elderly people who have to be provided with medication at home. One solution to these developments is the RoweMiniPump by RoweMed AG, a manufacturer of medical technology. It is the first pocket-sized mechanically-driven injection pump that patients can use to administer medication themselves with optimum dosing accuracy. Patients are more mobile as a result and also benefit from a high degree of safety and ergonomics. To realize the pump’s compact design, a high-tech plastic approved for medical technology was required, particularly for the housing components. “Makrolon® Rx 1805, which RoweMed has used to good effect in the past, was ideally suited to the complex requirements profile. Our polycarbonate provides the high level of transparency, impact strength, resistance to medication, and good sterilization properties required for this application,” explains Markus Krieter, a medical technology expert in the Polycarbonates Business Unit of Bayer MaterialScience AG.
The engineering plastic is used to make all the housing components. “The high transparency of our material enables patients to visually check the fill level of the medication quickly and easily,” says Krieter. Moreover, the blue components with guide channels, through which the medication flows, are also made of Makrolon® Rx 1805. “This is where the excellent chemical resistance of our material comes into its own. For example, it has a very high lipid stability, which makes it very successful as a material for intravenous feed systems, such as three-way stopcocks or manifolds,” continues Krieter. A key benefit in the production of the pump is the fact that the individual housing components made of Makrolon® Rx 1805 can easily be joined together through laser welding. In addition, the material also bonds superbly with other plastic materials using adhesives approved for medical equipment.
A key factor in RoweMed’s decision to opt for this material was the fact that the polycarbonate can be sterilized using high-energy radiation without long-term yellowing. The company also placed great emphasis on the robustness of the pump. As a mobile device, it must be able to withstand frequent “everyday accidents”, such as being dropped or hit. Makrolon® Rx 1805 is invaluable in these situations too, thanks to its high impact strength and toughness.
The refillable RoweMiniPump is suited to a wide range of applications – from chemotherapy, pain treatment and cardiology to the administration of antibiotics, corticoids, hormones and antiepileptic drugs. One of the key advantages of the pump is its dosing accuracy. During the entire injection time, the flow rate only deviates by a maximum of ± 5 percent. Depending on the size of the pump, the volume of medication remaining in the pump is between one and five percent, ensuring maximum cost-effectiveness.
Consistency of formulation and long-term availability of the products
For decades now, Bayer MaterialScience has been a partner to the international medical technology industry and market leader for polycarbonates in this market segment. “A large part of our success is based on the trust we have built up with many well-known medical technology manufacturers, mainly in the form of exclusive development partnerships. It is very important for us to be seen as a reliable partner, which is why we are committed to meeting the particular needs of this sector,” explains Krieter. For example, Bayer MaterialScience assures the long-term availability of the materials used for medical technology, ensures reliable delivery, and provides binding assurances that all the formulations will remain constant. Moreover, all materials supplied for medical technology meet the requirements of the American standard US Pharmacopeia, Class VI, relating to the biological compatibility of plastics. The same is true for the international ISO 10993-1 standard covering the biocompatibility of plastics that remain in contact with body fluids and tissue for up to 30 days. If required, Bayer MaterialScience will provide a comprehensive service to support manufacturers of medical instruments and the associated plastics processors, from the initial idea and design of the plastic components to mold construction and production launch. For instance, in the case of the injection pump, experts at Bayer MaterialScience helped optimize the gating and mold design.
RoweMed AG in Parchim (www.rowemed.de) is an innovative, international company that manufactures specialty products for medical technology. Its core competencies include the development, production and marketing of products for injection, infusion and transfusion technology, special systems and OEM business. The product portfolio is augmented by injection and infusion filters and spikes.