Beznoska is a manufacturer of orthopaedic implants, based in the Czech Republic. They sought to simplify their solvent cleaning process of implants, and improve what was a very labour intensive process for operators, by switching to a new MEG machine using 3M™ Novec™ 72DA fluid. The switch has led to an improved working environment, a much simpler process and excellent acceptance of the new regime by workers.
Improved cleaning of orthopaedic implants at Beznoska.
Beznoska is a Czech-based developer and manufacturer of implants and surgical tools for orthopaedic surgery. Based in Kladno, they operate in the Czech Republic and trade mostly throughout Eastern Europe. They pride themselves on manufacturing innovation and have been awarded several patents for hip joints and ligament apparatus.
No room for error
Since Beznoska implants end up in the human body, there can be no compromise on cleaning of the devices during the manufacturing process. The devices must be 100% clean, as the smallest amount of contamination could cause a toxic burden for the patient, or failed integration of the implant, leading to loosening. Both scenarios could result in repeat surgery. From a manufacturing perspective, anything less than a positive result during periodic process evaluation leads to delay in product finishing and can cause additional costs to remedy.
The old regime
Previously, the cleaning regime for orthopaedic implants used a combination of alkaline and acidic industrial, water-based degreasers, cleaning the implants at elevated temperatures in an ultrasound bath. This was followed by rinsing in clean water and drying with compressed air, all operations being performed manually. The old regime was a very labour-intensive process, requiring lengthy preparation at the start of each shift. An improved system was sought to simplify the whole process, and also improve the working environment for operators.
The new process
Now, an operator places the newly manufactured parts onto a tray, which is automatically grabbed by a robotic arm and transported into the 90 litre cleaning tank of the new MEG machine. The tank is divided into two sections. In the first one, parts are pre-cleaned in vapours of 3M Novec 72DA Engineered Fluid at a temperature of 42°C. The robotic arm then moves the tray into the second section. Here the tray is completely immersed in Novec fluid and the ultrasound is started, with tray movement applied for better cleaning.
After the cleaning cycle the tray is elevated above the fluid level, where cooling coils are located. Here, the quickly evaporating 3M Novec 72DA Engineered Fluid condensates back into the tank. In the last step, the robotic arm moves the tray back to a loading/unloading area where an operator removes the clean parts. Tests are used to verify the cleaning efficiency and check all substances are removed from part surfaces.
Jiri Bichler, Head of Production at Beznoska was responsible for the switch to the new cleaning regime using 3M Novec 72DA Engineered Fluids. He comments: “Our main motivation was to improve the working environment at Beznoska and the new regime has been well accepted. The machine is very easily operated and the whole process performs very well. For any MedTech companies who intend to improve the quality, safety or overall process of their cleaning regime, Novec fluids are definitely worth considering.”