Cleaning Fluids that comply with European Medical Device Regulations

1 min read

The Kemet cleaning fluid range is designed to be efficient, simple and compliant. The simplification of this range was made possible by the implication and coordination of all departments: R&D, production/HSQE, purchasing. Informed about the new challenges the medical industry faces, they managed to condense contradictory requirements: efficiency, availability, cost control, regulatory compliance.

Kemet International are the UK distributor for NGL Nordic A/S with more than 300 high performance formulations providing a solution to most cleaning challenges.

In addition to regulations and standards, NGL's approach includes knowledge of materials but also anticipation of process and material evolutions, such as additive manufacturing, or passivation following laser marking. Extending their collaboration to other players in the production chain (equipment manufacturers, consultants, laboratories, manufacturers of consumables, etc.) allows us to develop new solutions.

ISO 9001, ISO 14001 and ISO 45001 are the basis of their quality management, in addition to multiple control steps all along the production cycle. They are committed to continuous improvement in order to bring ever better quality to their customers.

In a Medical Device cleaning process, avoiding bacterial growth, especially in demineralised water rinses, is a challenge. Water flows through sections which can be difficult to reach (bends, pipes, pumps) where the presence of micro-organisms is hard to measure and control. Without specific water treatment, biofilm can develop and proliferate all the way 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 Charles PERY, a manufacturer of medical implants and instruments in France.

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