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CLEANING FLUIDS THAT COMPLY WITH MEDICAL DEVICE REGULATIONS
The Kemet cleaning fl uid range is designed to be effi cient, simple and compliant. The simplifi cation 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: effi ciency, availability, cost control, regulatory compliance.
Before a cleaning process can be adopted, there are a number of regulations and standards that the process must adhere to. REACH regulation No1907/2006 determines what substances are not allowed within detergents, CLP regulations determine how a product must be identified and labelled in order to be acceptable for medical applications and Medical Device Regulations (DM 2017.745) dictates further types of chemicals and materials that cannot be used including materials of animal origin and products that contain nano particles. In addition, the cleaning fluids must be safe for the associates and must not contain any Biocides. Kemet’s range of medical cleaning and passivation fluids have all been tested to ensure compliance with these regulations so a customer can be confident of a successful validation. There are many different processes involved in medical device manufacture and each has its own Kemet solution when cleaning. After forging or casting, parts undergo several additional processing steps: machining, deburring, polishing, welding, etc... These can leave stubborn contamination, for which our strong alkalis are perfectly suited: RODACLEAN 2018 - For ultrasonic cleaning. Due to its high concentration of potassium and sodium hydroxides, Rodaclean 2018 efficiently removes soluble oils and polishing pastes, as well as most types of organic residues. DECOCLEAN 440 - is a very versatile product, suitable for the removal of neat oil in ultrasonic or spray cleaners (the machine must be equipped with an oil separator), but also polishing paste or various organic residues. All fully compatible with medical device regulations. Mild Alkalis for sensitive alloys and finishing, the GALVEX 20.01, which is used as a universal detergent without amines, allows degreasing on all materials and offers a high degree of finish due to its excellent rinseability. It is very versatile for interoperation cleaning (removal of polishing pastes), surface preparation before passivation, anodizing, electrochemical polishing or final cleaning before sterilization. DECOSPRAY TM is also a mild alkali for the removal of neat oils on sensitive alloys, in ultrasonic or spray processes. The machine must be equipped with an oil separator. DECOMET was developed to meet the requirements of the ASTM standard A967, this citric acid-based passivation agent solubilises free iron oxides, present on the surface of stainless steels, martensitic or austenitic and promotes the oxidation of chromium, to form a passive layer.
As well as cleaning fl uids, Kemet also off er;
Ultrasonic Cleaning Tanks ranging from 40 to 160 litres.
Vacuum Solvent Cleaning machines that can recover 99% of material waste.
Passivation lines that comply with ISO 7 clean room.
Contact Kemet on +44 (0) 1622 755287 or Sales@Kemet.co.uk to arrange cleaning trials, so Kemet can fi nd the ideal cleaning solution for you.
Product Overview
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