High level of EU qualifications achieved for the manufacturing of medical devices

13-16-01, Cleanroom

13-16-01, Inhaler

13-16-01, Misch- und Dosiersystem für Knochenzement,

The production of medical technology products is subject to a series of stringent regulations and requirements. "An indispensable prerequisite for the qualified production of complete systems, such as the mixing and dosing system for bone cement (see image), is the DIN EN ISO 13485 certification," explains Friedrich Echterdiek. This high level of qualification was achieved by Spang & Brands GmbH, Friedrichsdorf, as part of a consistent corporate strategy – after nearly a year of intensive preparations with corresponding reorganizations – in December 2012. TÜV Süd conducted the audit and certification. "With the success of these measures, we can now, at MEDTEC (Spang & Brands, Stand 1 M 49), offer our customers and other system suppliers in the medical and pharmaceutical industries an expanded development and production portfolio to deliver ready-to-use systems and primary packaging," adds the managing director of this qualified manufacturer of plastic components for medical technology.

During MEDTEC, from February 26 to 28, 2013, in Stuttgart, the company will showcase more than 50 different medical technology products, component groups, precision and micro-products in mono- and multi-component injection molding – syringes, cannulas, penetration membranes, implant parts, and components for minimally invasive medicine, connection elements, functional parts for infusion solution bags and closure systems, as well as assembled modules and ready-to-sell devices, whose accuracy and structures must be exemplary.

At Spang & Brands, specialized plastic blends are typically used, including resorbable materials, which can only be processed in high-performance tools: "We have been specialized for around 30 years in precision and cleanroom injection molding technology for the medical and pharmaceutical industries," explains Friedrich Echterdiek. "Especially for specific projects relevant to ISO 13485, we have the right technology with CAD-3D development, MoldFlow analysis, and over 50 injection molding machines in use – including fully electric ones – and above all, a continuously growing engineering expertise on our side." The fully automatic and manual assembly as well as the packaging of parts and modules take place in cleanrooms Class 8 (100,000), from pre-series or just-in-time produced batches to millions of units. Strategically positioned control points and 3D measurement technology support quality assurance.

"Functional parts are becoming smaller, more complex, and more precise – especially in medical technology. During MEDTEC, we will demonstrate that we master this technology – regarding part development, toolmaking, injection molding, cleanroom processes, assembly, and the entire value chain's production processes," affirms Friedrich Echterdiek.