Medical device cleaning is an essential process that involves the removal of contaminants, such as oils, debris, and microorganisms, from medical instruments and implants. The European Medical Device Regulations (MDR) have strict guidelines for the cleaning process of medical devices to ensure that the devices are safe and effective for use. One of the critical requirements is the use of cleaning fluids that comply with the MDR.
The Kemet cleaning fluid range is designed to be efficient, simple, and compliant with the European Medical Device Regulations. The range is the result of collaboration between the Research and Development (R&D), production/HSQE, and purchasing departments. They were informed about the new challenges faced by the medical industry and managed to condense contradictory requirements, such as efficiency, availability, cost control, and regulatory compliance.
Kemet International is the UK distributor for NGL Nordic A/S, which has over 300 high-performance formulations that provide a solution to most cleaning challenges. NGL’s approach includes knowledge of materials, anticipation of process and material evolutions, and collaboration with other players in the production chain, such as equipment manufacturers, consultants, laboratories, and manufacturers of consumables. This approach allows for the development of new solutions that comply with the MDR.
Compliance with the European Medical Device Regulations is a critical requirement for medical device cleaning fluids. ISO 9001, ISO 14001, and ISO 45001 are the basis of NGL’s quality management, in addition to multiple control steps all along the production cycle. They are committed to continuous improvement to bring better quality to their customers.
Preventing bacterial growth in demineralised water rinses is a challenge in medical device cleaning processes. Water flows through sections that can be difficult to reach, such as bends, pipes, and pumps, where the presence of microorganisms is hard to measure and control. If the water is not treated specifically, biofilm can grow and spread to the rinse tanks. Prevention through appropriate pre-treatment of the water is thus essential, even if water is heated to 70° and constantly circulated.
A pre-treatment solution has been successfully implemented for the final rinse of medical devices prior to entry into the cleanroom at a manufacturer of medical implants and instruments in France. This solution has helped prevent bacterial growth and ensure compliance with the European Medical Device Regulations.
The Kemet cleaning fluid range is designed to be efficient, simple, and compliant with the European Medical Device Regulations. Compliance with the regulations is a critical requirement for medical device cleaning fluids. Preventing bacterial growth in demineralised water rinses is a challenge in medical device cleaning processes. The pre-treatment solution has been successfully implemented for the final rinse of medical devices and has helped prevent bacterial growth and ensure compliance with the European Medical Device Regulations.
For more information on the Kemet ultrasonic cleaning range, please contact Kemet at [email protected].
