Closer to the µ than ever – medical devices in high-end precision

Two-component cap with rated breaking point

The investment into the new technology center (TC) at Spang & Brands, Frie-drichsdorf/Germany, could not have been more future-oriented. Here, all new customer pro-jects from the medical device, pharmaceutical and dental technology sectors enter the process chain – from design and product feasibility right through to pilot series. Not until the quality assessment department has given approval, the CAD/CAM product data are transferred to the manufacturing plant: for multiplication of a given medical device in multi-million batches.

Al-ways with one and the same high quality. Background: latest technological feature in the TC is a software package called CATIA Mold&Die. It is the basis for guaranteed consistency of the CAD mould data and highest possible precision during CAM of the moulds for medical devices: “… with a precision level up to the last µ”, says Technical Director Alexander März.

During COMPAMED, Spang & Brands will exhibit more than 100 different medical products – component groups, precision and micro products manufactured in mono or multi-component injection moulding technology. Among the exhibits are syringes, cannulas, push-through membranes, implant components and those for minimally invasive medicine, fastening/joining elements, functional parts for infusion solution bags and closure/sealing systems, as well as assembled units and ready-for-sale devices where accuracy and structure must be – and is – exemplary.

Pencil point spinal needle with magnifying glass

On the whole, Spang & Brands uses very particular plastics blends, including resomere mate-rials, those that can only be processed using state-of-the-art high-performance moulds:

“For the past 30 years or so, we have specialised in precision and clean-room injection moulding for the medical and pharmaceutical industries …,” states CEO Friedrich Echterdiek, and continues “… for just those special ISO 13485 relevant projects, we employ the right technologies with CAD-3D development and MoldFlow analysis. We have more than 65 active injection moulding machines – including all-electric machines. Most importantly, we take full advantage of our continuously growing engineering know-how.“

In Class 8 (100,000) clean-rooms, fully automatic and manual assembly takes place, not forgetting the packaging of components and assembly units ranging from pilot/preproduction series and just-in-time produced batch sizes right through to runs of many millions. Strategically positioned checkpoints and 3D precision metrology support the company’s stringent quality surveillance and assurance system.

“The demand for smaller, more complex and more accurate functional components with an emphasis on patents’ safety is continuing to rise – this is particularly relevant in medical tech-nology. During COMPAMED, we will demonstrate that we master the corresponding technolo-gies, those regarding, among others, the development of components, mould making, injec-tion moulding technology, the topic of clean-room production, and assembly, in other words the complete range of production processes within the entire value-added chain”, concludes Jürgen Mader, Director at Spang & Brands.