"At Somi Medical, we clean, assemble, sterilise and package a wide variety of medical devices on a daily basis, primarily in the fields of oral surgery, orthopaedics and traumatology. Due to the different and very complex geometries of the implants and instruments, we were looking for a cleaning system that is as flexible as possible and, above all, delivers cleaning results with <10 CFU (bioburden)," says Rainer Johe from Somi Medical. "In addition, it was important to us that the cleaning system fits seamlessly into our manufacturing process in order to achieve a continuous and high throughput of goods. The ultrasonic cleaning system from Elma fulfils exactly these criteria."
In the closed X-tra line ultrasonic cleaning system from Elma, Somi Medical instruments and implants are cleaned, rinsed and dried in six stations. Loading and unloading belts as well as a transport robot ensure smooth transport of goods through the system and along the production process. The optimal cleaning process was tested together with Somi Medical in the Elma process laboratory and individually adapted. Depending on the cleaning task, the process and the transport sequence in the system can be freely programmed to suit the different geometries of the instruments or implants.
Thanks to the integrated lift-rotation, the product baskets can be rotated horizontally, swivelled, lifted and lowered individually depending on the part geometry. In this way, even the smallest blind holes, bores or undercuts can be cleaned in a targeted manner and, at the same time, the media carry-over into further cleaning baths can be significantly reduced. This means that the system can be operated in a resource-saving way - less rinsing water and lower power consumption.
Somi Medical cleans with Highly Purified Water (HPW) and with the alkaline cleaner Elma Medtech Clean A25 (medical device class 1 according to MDR). Drying is carried out in combination with hot air and vacuum to dry the instruments and implants without leaving any residues. The goods are transported under laminar flow units from the last HPW rinse to the transfer to the clean room. This enables direct completion or packaging of the parts in the connected clean room.
To ensure specified and validated processes, the system is equipped with AuditTrail software (FDA CFR 21 Part 11). This allows access to defined process data for trained and licensed employees directly from Somi Medical. Each batch and its order data are recognised by means of an RFID reader before the cleaning process and all process data per batch and process station are logged during the process run using Elma data logger software. This data is made available for quality assurance after the cleaning process has been completed.
Our After Sales Service ensures that the system is professionally maintained (maintenance contracts) and spare parts packages are available. On request, the ultrasonic performance of the system is qualified at Elma's factory and confirmed in the factory test certificate. The ultrasonic performance can also be regularly requalified during regular system maintenance.
The X-tra line ultrasonic cleaning system for Somi Medical was individually assembled from the modular system construction for the applications and requirements of Somi Medical. It is precisely this individuality in the equipment and the resulting high availability that make the X-tra line ultrasonic systems stand out. In addition to the fully automated transport of goods with loading and unloading buffers, the modular construction system also includes automatic filling or refilling of the process chambers, including the feeding and re-dosing of the cleaner by means of conductivity monitoring in the ultrasonic bath.
Find our article also on DeviceMed France and JOT.