Ecoclean will participate in two industry events to present its turnkey solutions for the cleaning and sterile packaging of medical device products that comply with the requirements of the new MDR and FDA.
On the occasion of the Med-Tech Innovation Expo and the Swiss Medtech Expo, SBS Ecoclean Group will present new turnkey solutions for the cleaning and packaging of medical devices that comply with requirements of the Medical Device Regulation (MDR) and FDA.
Medical products are manufactured using various processes - primary shaping, forming, machining, extrusion, injection moulding and additive manufacturing - which leave residues on the surface. These contaminations represent potential harm to patients depending on the risk class in which a medical device is classified and must therefore be removed.
The new MDR, which went into effect at the end of May 2021, has made several changes in the classification system and regarding the cleaning of components. Thus, in addition to the bioburden and cytotox values, particulate and filmic contamination from the manufacturing processes are now also considered. In addition, the requirements for process validation and qualification, component identification and traceability have increased.
New turnkey solutions at Med-Tech Innovation Expo and Swiss Medtech Expo
At its booth SBS Ecoclean Group will provide information on its comprehensive and globally available range of qualified cleaning systems for pre-cleaning, intermediate cleaning, final cleaning and ultra-fine cleaning in medical technology.
The software solutions
developed for medical technology applications and RFID technologies, Audit-Trail and CFR ensure compliance with all process parameters and the automatic production data acquisition and traceability. In addition, Ecoclean portfolio includes clean rooms and packaging solutions that include pre-validated packaging materials for implants and instruments.
SBS Ecoclean Group's team will also provide information about the qualification of plants according to IQ, OQ and PQ, which are part of the scope of delivery on request.
At the Swiss Medtech Expo, which will be held from 14 to 15 September at Messe Luzern, you will find Ecoclean in hall 2, stand D 2107; while at the Med-Tech Innovation Expo, which will take place from 28 to 29 September 2021 at the NEC in Birmingham, the company will be in hall 2, stand B28.