Purity validation in medical technology: Finding a unique path as an industry

In an increasingly aging society, medical technology products are gaining more and more importance. The highest quality and purity requirements are necessary in their manufacturing. But purity goes far beyond the question of hygiene. On July 3, 2014, purity experts will meet at the Fraunhofer Institute for Production Technology and Automation IPA in Stuttgart to advance the dialogue on practical implementation of cleanliness requirements.

Despite the use of established cleanroom technology, critical contamination in medical technology products cannot be completely ruled out. About a quarter of all recall actions of corresponding products by the U.S. Food and Drug Administration (FDA) between 2001 and 2011 were due to insufficient purity. In Germany alone, the economic damage caused by rejection reactions of the body due to impure medical products amounts to around seven billion euros annually. Thus, the introduction of contaminants by personnel, equipment, or process media endangers patient safety as well as the future of a medical technology company.

When it comes to "cleanliness" in the context of life sciences and pharmaceuticals, the focus has so far been on microbiological contamination. But purity encompasses much more than hygiene issues: "We also think of other contaminants such as particles in general and chemical film residues," says Dr. Markus Rochowicz, head of the IPA Purity Technology Group. From a particle size of 1 µm, the Stuttgart researchers also examine the dimension and material composition of the corpus delicti to make statements about its origin.

In response to the tendency to rely on typical pharmaceutical procedures for purity issues, Fraunhofer specialists contrast this with a focus on other industries: In the automotive industry, particulate cleanliness has long been a topic. At the same time, efficiency and cost-effectiveness are of key importance. Therefore, automakers have developed fixed procedures for selecting the right cleaning and analysis methods. "By looking at the pharmaceutical sector, the purity standards in medical technology are sometimes exaggerated — it's time to find a practical, industry-specific approach," says Fraunhofer IPA project manager Guido Kreck. Here, within the boundaries of their own systems, a sensible plan must be developed — ensuring maximum protection with high economic efficiency.

On July 3, 2014, Fraunhofer IPA will host an open workshop to discuss key questions about safe products and purity validation with stakeholders from the medical technology industry. This kickoff for an industry-internal dialogue is all the more important given the upcoming tightening of the Medical Devices Act at the European level. (Ulrike Felger)