Gemü Medical Technology relies on cleanroom and plastics

"The plastic content in medical products is increasing, while metal is decreasing," is the forecast from Sven Müller, Head of Medical Technology Engineering at the Swiss manufacturer Gemü, presented at MEDTEC Europe in Stuttgart (Hall 1, Stand 1M10). The company opened a new cleanroom facility in Emmen, Switzerland, six months ago and has since seen increased demand for injection-molded products for the medical technology sector. Significant contributions have come from the latest manufacturing techniques and a cleanroom environment according to ISO Class 8 and GMP Class C standards. The two-story new building is designed so that the manufacturing process—from material supply through production and subsequent assembly to packaging—can take place under cleanroom conditions.

With the new cleanroom facility, Gemü has further expanded its capacity for manufacturing medical technology products. In the injection molding area, 1,800 sqm are available for Class 8 production, and 1,000 sqm are dedicated to assembly. "We expect the trend toward series production of high-performance plastics to continue," says Müller. Today, application-specific PEEK components for surgical drills are already produced in larger quantities. However, Müller sees limits for the use of plastics in mechanically heavily stressed parts: "There are cases where plastic would be the poorer material choice due to its flow properties," reveals the technical manager.

Quality assurance is paramount in cleanroom operations. Gemü pays close attention to both the system risks of the equipment and the assessment of process risks. Each project receives a so-called risk file, documenting every development step, which remains available as documentation long after project completion. The basis for validation is the ISO standards, the guidelines of the US regulatory authority FDA, and the EU GMP guidelines. Despite its expansion plans, the primary target market for Gemü's medical division remains Switzerland.