Cleaning Fluids Compliant With European Medical Device Regulations: Ensuring Efficiency And Regulatory Compliance
The range of Kemet ultrasonic cleaning fluids has been meticulously developed to meet the demands of the medical industry while adhering to European Medical Device Regulations. By fostering collaboration and synergy among various departments including Research and Development (R&D), production/Health, Safety, Quality, and Environment (HSQE), and purchasing, Kemet has successfully simplified their product line. This streamlining process took into account the evolving challenges faced by the medical industry, reconciling seemingly contradictory requirements such as efficiency, availability, cost control, and regulatory compliance.
As the UK distributor for NGL Nordic A/S, Kemet International offers over 300 high-performance cleaning formulations that provide effective solutions for a wide range of cleaning challenges. NGL Nordic A/S not only ensures compliance with regulations and standards but also possesses extensive knowledge about materials and anticipates future developments in processes and materials, including additive manufacturing and passivation following laser marking. Furthermore, their collaboration extends beyond their own organisation, encompassing other stakeholders in the production chain, such as equipment manufacturers, consultants, laboratories, and consumables manufacturers. This collaborative approach enables the development of innovative solutions that address the evolving needs of the industry.
Quality management forms the foundation of NGL Nordic A/S’s operations, with ISO 9001, ISO 14001, and ISO 45001 serving as the bedrock of their commitment to excellence. Multiple quality control measures are implemented throughout the production cycle, ensuring stringent standards are met. Continual improvement is an integral part of their ethos, as they strive to deliver ever-improving quality to their valued customers.
Within the context of medical device cleaning processes, preventing bacterial growth, especially in demineralised water rinses, presents a significant challenge. Water often flows through intricate sections of the equipment, including bends, pipes, and pumps, where the presence of microorganisms is difficult to assess and control. In the absence of proper water treatment, biofilm can develop and proliferate within the rinse tanks. To combat this issue, a successful pre-treatment solution has been implemented at a renowned French manufacturer of medical implants and instruments. By employing appropriate pre-treatment measures, even when water is heated to 70°C and continuously circulated, the formation and growth of biofilm can be effectively prevented. This pre-treatment solution ensures that medical devices are thoroughly cleaned before entering the cleanroom.
For further information about the Kemet cleaning fluid range and its applications, please contact Kemet directly at sales@kemet.co.uk.
