Turnkey solutions for the cleaning and sterile packaging of medical devices

With the specially designed cleaning and packaging applications in medical technology, the requirements of the new MDR and FDA can be met in a process-safe and efficient manner. (Image source: Ecoclean)

With the new MDR valid since May 26, 2021, the requirements have increased both for cleaning and identifying components for medical technology as well as for qualification, documentation, and traceability of the processes. At the Swiss Medtech Expo (Hall 2, Stand D 2107) in Lucerne, the SBS Ecoclean Group provides information about innovative, globally available turnkey solutions for cleaning and packaging medical technology products, which enable process-safe and efficient compliance with MDR and FDA requirements.

The manufacturing of the products takes place using various production methods such as forging and forming, machining, extrusion, injection molding, as well as industrial 3D printing, which leave particulate and/or film-chemical residues on the surface. These contaminants, for example processing media, release agents, particles, chips, burrs, abrasives, dust, fingerprints, or residual powder, pose varying degrees of potential harm to patients depending on the risk class into which a medical device is classified, and therefore must be removed. The new Medical Device Regulation (MDR) has not only resulted in changes to the classification system but also regarding the cleanliness of parts. In addition to bioburden and cytotoxicity values, particulate and film contamination from manufacturing processes are now also considered. When it comes to process validation and qualification, component identification, and traceability, the requirements have also increased.

The SBS Ecoclean Group provides information at the Swiss Medtech Expo in Hall 2, Stand D 2107 about its comprehensive and globally available program of qualified cleaning systems for pre-, intermediate-, final-, and precision cleaning in medical technology. Specially developed software solutions and RFID technologies, audit trail, and CFR 21 ensure that all process parameters are maintained and that seamless automatic operational data collection and traceability are guaranteed. This portfolio is complemented by cleanroom and packaging solutions, which already include validated packaging materials for implants and instruments. The expert team of SBS Ecoclean Group also offers information on support for plant qualification according to IQ, OQ, and PQ, which can be included in the scope of delivery upon request.