At MedtecLIVE with T4M (Hall 10, Booth 10-432) in Stuttgart, Germany, the SBS Ecoclean Group will be showcasing its innovative, globally-available turnkey solutions for cleaning and aseptic packaging of medical devices. These solutions ensure that the stringent MDR and FDA requirements are met reliably, reproducibly and efficiently.
Increasingly stringent requirements and stricter regulatory standards set by the MDR and FDA pose ever-greater challenges for manufacturers of medical products such as implants, instruments and diagnostic devices. This also applies to the cleaning and sterile packaging of these goods. For one, residues from manufacturing processes need to be removed, such as processing media, release agents, particles, chips, burrs, abraded particles, dust, fingerprints or residual powder. For another, the steps of final cleaning, transfer to a suitable cleanroom and sterile packaging must ensure that the medical device does not pose a health risk to the patient.
These processes have become all the more important since the MDR was introduced last year because they are now considered as critical parts of the product. Requirements in terms of process validation and certification, component identification and traceability have also increased.
The SBS Ecoclean Group, together with its cooperation partner VC999 Medical, will be informing visitors about its comprehensive and globally- available range of turnkey solutions for cleaning and medical products at MedtecLIVE with T4M (Hall 10, Stand 10-432), which will be held in Stuttgart, Germany, from May 3 to 5, 2022. This includes information on certified cleaning systems for pre-cleaning, intermediate cleaning and final cleaning.
One example of what the company will be showcasing at MedtecLIVE is the UCMSmartLine, an ultrasonic multi-chamber immersion cleaning system that can be flexibly configured. The space-saving cleaning solution can be designed with up to nine wash and rinse stages as well as with mono (25, 40, 80 kHz), twin (25/50, 40/80 kHz) and multi-frequency ultrasonics
(40/80/120 kHz) for pre- and intermediate cleaning operations.
With software solutions and RFID technologies specially developed for the medical device industry, Audit Trail and CFR 21, Ecoclean not only ensures adherence to all process parameters but also automatic end-to-end production data acquisition and traceability. In addition, the team of experts from the SBS Ecoclean Group will be offering visitors information on support with equipment certification in accordance with IQ, OQ and PQ, which is also included in the scope of delivery on request.
The portfolio is rounded off by solutions for transferring products into a cleanroom. Packaging machines, including already pre-validated packaging materials, also play a role in enabling medical technology companies to minimize the financial and organizational effort involved with cleaning and packaging their products.
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