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The European Medical Device Regulation (MDR) and FDA have imposed on the medical device sector regulations and requirements governing product safety, process validation and quality management that are stricter than in almost any other industry. This also affects cleaning processes for parts and components. To meet regulatory challenges, an international manufacturer of knee implants has replaced its intermediate and final cleaning equipment with the UCMSmartLine. The ultrasonic multi-chamber immersion cleaning system, which is based on standardized modules, can be individually configured for specific tasks and enables validated cleaning and passivation processes to be seamlessly monitored and documented.
With the introduction of MDR, the requirements for cleaning medical devices such as implants, as well as for validating, documenting and tracing the respective processes, have become much more stringent. However, FDA plans to harmonize its quality system regulations with MDR. This will make it easier for medical device companies to comply with requirements in the future, regardless of whether they manufacture their products in the U.S. or Europe or export them there.
The exacting regulations imposed by MDR require manufacturers and suppliers of parts and components to adapt their cleaning and passivation processes. This was also the case with a global manufacturer of titanium knee implants. A key stipulation made by the company was that the new equipment for intermediate and final cleaning should be easy to validate, and that the parameters of the validated processes should be consistently monitored and documented. In addition, the equipment and processes had to be easy to duplicate for sites in other countries.
One System for Both Applications
After conducting market research, the company opted for the UCMSmartLine system for both tasks. The system is made by the Swiss company UCM AG, a division of the SBS Ecoclean Group that specializes in ultra-fine and precision cleaning. The deciding factor was the concept of the ultrasonic multi-chamber immersion cleaning system, which is based on standardized modules for cleaning, passivation, rinsing and drying, as well as loading and unloading. The goods are transported by an integrated automated system, complete with servo drive, that comes standard. The electrical and control technology is integrated into each unit so extra space for a control cabinet is no longer needed.
This flexible and cost-efficient plug-and-play design allows the systems to be individually configured for pre-, intermediate and final cleaning applications with the highest cleanliness requirements. UCMSmartLine is equipped with modern sensor technology and additional methods to measure parameters such as pH, conductivity, density, ultrasonic frequency and output, so all relevant process parameters can be seamlessly recorded, controlled and documented. The data is transmitted to the company’s higher-level Manufacturing Executive System (MES) via an interface integrated into the UCMSmartLine’s PC-based controller.
Task-specific Configuration
For batch-by-batch intermediate cleaning of the knee implants, in which residues from grinding or polishing processes are removed, the fully enclosed system has a total of six wet stations with tanks measuring 370 x 420 x 390 mm (L x W x H). During the two cleaning and four rinsing cycles, multi-frequency ultrasound with 25 and 40 kHz is used in addition to injection flood washing and pulsed pressure cleaning (PPC).
The two-sided overflow developed by UCM AG comes standard and contributes to consistently good cleaning results: media are introduced from below, transported to the top and then overflow on two sides. This creates a constant flow that not only promotes intensive treatment of the parts but also makes sure that detached particles and other residues are immediately removed from the baths, thus minimizing the risk of parts becoming recontaminated when they are moved or lifted out. After the drying step in the integrated vacuum dryer, the implants are subjected to a full visual inspection.
Final Cleaning
The UCMSmartLine configured for final cleaning has seven wet stations. A cleaning and rinsing step are followed by passivation, during which the quality of the medium is monitored by measuring its density. After subsequent neutralization, the parts are subjected to three rinsing steps with corresponding water qualities. The cleaning and rinsing effect are also reinforced by injection flood washing, PPC and ultrasound with a frequency of 40 kHz during final cleaning. The newly developed Acoustic Performance Measurement (APM) system provides in-line monitoring of the parameters of ultrasonic frequency and output at each processing station for each batch.
Special directional microphones that are used for monitoring are placed in a fixed position at the edge of each tank and directed toward the center of the bath surface. Measurements are therefore carried out without any movement or contact, ensuring reproducible results and enabling them to be precisely assigned to the batch concerned. Analysis, evaluation and storage of the data are handled by the software of the innovative measuring system. Thanks to the special lift-out function of the transport system, the parts are effectively pre-dried following the last rinse before being transferred to the vacuum dryer for the final drying step, which dries the parts completely and ensures a spotless finish.
At the outfeed section, the system is connected to the cleanroom by a double airlock. Due to consistent monitoring of the process parameters and the continuous comparison with validated process data, bad baskets in which discrepancies have been detected can be removed from the product flow before reaching the cleanroom.
Due to the highly flexible design of the system and processes, UCMSmartLine is suitable for a wide range of applications. The standardized modules simplify equipment certification and process validation and make it easier to duplicate the cleaning systems and processes for further sites.
Contact:
Ecoclean, Inc.
Phone: +1 947-272-0600
info.usa@ecoclean-group.net
