Cleaning fluids compliant with regulations for medical equipment
The term “medical devices” covers a wide range of products. These include surgical instruments and tools that do not stay in the body or orthopedic and dental implants designed to stay inside the patient.
There are very restrictive settings and controls surrounding the cleaning of these types of components as expected, especially for surgical tools or instruments designed to remain inside the body. Any contamination that may result from the manufacture of the part must be completely removed, whether it is abrasive particles, cutting oils or polishing paste.
This must be done in addition to ensuring that detergents and the cleaning process leave no potentially harmful residues that could be detrimental to the patient.
The cleaning process must comply with several regulations and standards before it can be adopted. CLP regulations determine how a product must be identified and labeled to be acceptable for medical applications. The REACH regulation n°1907/2006 determines which substances are not authorized in detergents.
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Finally, the Medical Devices Regulation (DM 2017.745) determines the restrictions on the different types of chemicals and materials that cannot be used, including products containing nanoparticles and materials of animal origin.
Cleaning fluids must not contain biocides and must be safe for associates. To ensure compliance with these regulations, Kemet’s range medical cleaning and passivation fluids have all been tested to allow a customer to be sure of successful validation.
There are many different processes involved in the manufacturing of medical devices, and when cleaning, each has its own Kemet solution.
Parts undergo several additional processing steps after forging or casting: machining, deburring, polishing, welding, etc. These steps can leave stubborn contamination for which strong alkalis are perfectly suited.
Ultrasonic cleaning: RODACLEAN 2018
Rodaclean 2018 effectively removes polishing pastes and soluble oils thanks to its high concentration of potassium and sodium hydroxides and most organic residues. A more versatile product, DECOCLEAN 440, is ideal for removing polishing paste or various organic residues and whole oil in spray or ultrasonic cleaners (the machine must be equipped with an oil separator). All are fully compatible with the Medical Device Directives.
When looking for mild alkalis for sensitive alloys and finishing, GALVEX 20.01 facilitates the degreasing of all materials, offers a high degree of finishing thanks to its excellent rinsability and is used as a universal detergent without amines.
It can be used for inter-operation cleaning (removal of polishing pastes) and surface preparation before anodizing, passivation, electrochemical polishing or final cleaning before sterilization. In ultrasonic or spray processes, DECOSPRAYMT is also classified as a mild alkali for the removal of neat oils from sensitive alloys. The machine must be equipped with an oil separator.
To meet the requirements of the ASTM A967 standard, DECOMET has been developed: a passivation agent based on citric acid which creates a passive layer by solubilizing the free iron oxides present on the surface of stainless steels, austenitic or martensitic, and favoring the oxidation of chromium.
RUBIFIN N°4 is an A3 solvent used for degreasing in vacuum or ultrasonic machines. No greasy residue remains on parts during a vacuum cleaning process thanks to its hydrocarbon-free formulation. It can also be used in hybrid processes (solvent/detergent) with Decoclean 440 or DecosprayMT and is ideal for sensitive alloys such as aluminium.
Kemet’s range of cleaning fluids have been designed to be simple, effective and compliant. The involvement and coordination of all departments, including purchasing, R&D, production and HSQE, has made the simplification of this range possible. Once informed of the new obstacles facing the medical industry, the services were able to condense the contradictory requirements: efficiency, availability, regulatory compliance and cost control.
Founded in 1938, Kemet International Limited is at the forefront of precision lapping and polishing technology, using Diamond Compound and Diamond Slurry, which are manufactured in-house to ISO 9001:2015 quality standards. We offer innovative solutions to operations that require precision finishing and close tolerance. Kemet’s highly specialized and precise honing machines can machine a wide variety of materials for many applications.
Operating at the forefront of orthopedic implant polishing technology For over 20 years, Kemet International Ltd has transformed the quality and cost of manufacturing tibial trays and hip heads/cups.
Kemet’s process laboratories are fully equipped with the latest range of lapping machines, polishing machines, ultrasonic cleaners, mold polishing and metallographic and geological sectioning equipment to carry out testing on customer samples . In addition, our team of industrial chemists is able to custom manufacture diamond lapping and polishing compounds and diamond suspensions.
Let Kemet help you develop a new process, reduce costs or solve immediate technical problems. Kemet offers training covering all aspects of lapping and polishing at our lapping labs or at your own facility. Kemet International actively participates in major trade shows and exhibitions and has received numerous awards for our achievements internationally.
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