Parts cleaning in the medical device industry
Medical products such as implants, instruments, cannulas and endoscopes, place specific demands on cleaning processes and packaging. These include the reliable removal of contamination from manufacturing processes, even from capillaries, complex geometries and porous surfaces. All traces of powder must be removed from additively manufactured components using powder bed processes. Parts and assemblies for large-scale equipment such as X-ray systems or computer tomography and magnetic resonance imaging (CT and MRI) system also require extremely high levels of particulate and thin-film cleanliness. In addition, regulations such as FDA and MDR must be complied with in terms of product identification, equipment qualification, documentation and traceability of components and processes. For these tasks in the medical device industry, Ecoclean offers future-oriented, turnkey cleaning solutions including cleanroom and packaging systems that are available around the globe, with local service.
As a full-range supplier, Ecoclean covers the entire spectrum of parts cleaning. In addition, the company’s portfolio includes solutions for aqueous and solvent-based surface treatment, automation, cleanroom systems, as well as packaging systems for implants and instruments with validated packaging materials. Adapted to the specific demands and applications (e.g. pre-, intermediate or final cleaning, material, component geometry, type of contamination and cleanliness requirements), different systems are available for individual part and batch cleaning with environmentally compatible solvents and water-based media. Partial cleaning can be carried out reliably and efficiently with our dry cleaning processes. Targeted surface activation, for example of specific areas of implants to optimize osseointegration, is made possible by our water-based solutions for activating surfaces without the addition of abrasive media. Software, RFID technology, audit trail and CFR 21 specially developed for the medical technologies sector ensure the end-to-end identification, documentation and traceability of components.
To solve the highly varied tasks encountered in the medical device industry in a requirement-oriented, sustainable and efficient way, comprehensive technological expertise is indispensable. However, knowledge about the applications and corresponding regulations (FDA, MDR) is also called for. Thanks to our many years of experience and numerous successfully completed projects, we have both. This, in conjunction with our extensively equipped Technology Centres including cleanliness labs and clean rooms, enables us to carry out cleaning tests for the medical technologies sector on original-soiled parts under near-production conditions in order to solve any cleaning task. Based on the respective material, component geometry, type of contamination, cleanliness and throughput requirements, we develop cleaning solutions that are not only technically and economically optimized but also future-proof - we automate them too, if desired. If required, our experts also offer support with IQ, OQ and PQ qualifications.