With the new Medical Device Regulation (MDR) in force since end of May 2021, requirements for cleaning and identifying parts for medical engineering products, as well as for the qualification, documentation and traceability of the processes, have significantly increased.
At the Med-Tech Innovation Expo (hall 2, booth B28) held 28 & 29 September at NEC in Birmingham, the SBS Ecoclean Group will provide information on innovative, globally available turnkey solutions for the cleaning and packaging of medical technology products, with which the requirements of the MDR and FDA can be met in a process-safe, stable and efficient manner.
Medical products are manufactured using technologies such as primary shaping, forming, machining, extrusion, injection moulding and additive manufacturing, which leave particulate and filmic residues on the surface. These contaminations (for example, processing media, release agents, particles, chips, burrs, abrasion, dusts, fingerprints or residual powder) represent a varying degree of potential harm to patients depending on the risk class into which a medical device is classified and must, therefore, be removed.
The MDR has not only resulted in various changes in the classification system, but also regarding cleanliness. In addition to bioburden and cytotoxic values, particulate and filmic contamination from the manufacturing processes are now also considered. Requirements regarding process validation and qualification, component identification and traceability have also increased.
At the the Med-Tech Innovation Expo, SBS Ecoclean Group will provide information about its comprehensive and globally available range of qualified cleaning systems for pre-cleaning, intermediate cleaning, final cleaning and ultra-fine cleaning in medical technology. Software solutions specially developed for medical technology applications and RFID technologies, Audit-Trail and CFR 21 ensure that all process parameters are adhered to and seamless automatic production data acquisition and traceability are guaranteed. This portfolio is rounded off by cleanroom and packaging solutions that include already validated packaging materials for implants and instruments. Information is also provided on support for plant qualification in accordance with IQ, OQ and PQ, which are part of the scope of delivery on request.