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Oemeta Chemische Werke GmbH

Ossenpadd 54 25436 Uetersen Schleswig-Holstein Hinrich Voss +49-4122-924-226 +49-4122-924-28-226 voss@oemeta.com www.oemeta.com

I

1916

Metal removal fluids, industrial fluids

Member of

A tradition for the future in MedTech production

Although Oemeta Chemische Werke GmbH has been in the market for over 105 years, its coolant technology is designed for tomorrow’s expectations. The requirements of medical technology manufacturing were considered in product development specifications for state-of-the-art coolants before tailoring a whole product line to MedTech. Oemeta has always been on the forefront of modern and visionary philosophies in coolant technology and is known to have best practice expertise.

Ongoing, as well as global challenges in the MedTech environment are monitored and taken care of by assigned R&D and production efforts, with manufacturing capabilities in Germany, China, and the US. Competences and experiences from various industries influence the design of new products, whether the focus is on sustainability, process optimisation, or regulatory affairs, etc. The fundamental bases for any Oemeta products are the global, current, and upcoming regulatory legislation for chemical ingredients and raw materials.

Process performance, human compatibility, and economic efficiency have always been the core philosophies at Oemeta, but since technology is developing at an even faster pace and demographics show that society is getting older, medical technology is playing an increasingly important role.

The new MedTech product portfolio from Oemeta is tailored to the requirements of modern manufacturing processes and advanced materials. Highly sophisticated materials such as titanium, tantalum, niobium, magnesium, ceramics, polymers, etc. are the standards of today’s medical world and require specific coolants to achieve safe and efficient machining results. Coolants must not have any influence on material surfaces and structural integrity, must be bio-compatible for any absorbent material, and still fulfil the manufacturing requirements for sump life, clean working environment, tool wear and equipment protection. A very fine line for perfection!

The European MDR requires any manufacturer of medical parts/equipment to implement quality management documentation to EN-DIN 13485 to ensure all regulatory specifications are met. Part of this auditing process is the qualification of the final product as bio-compatible, based on EN-DIN 10993. If the final product is qualified, the process is locked in and no changes are accepted without a new and full auditing process. In the event that the manufacturing fluids need to be replaced for newer technology, proven non-cytotoxic fluids can ease the re-evaluation of the process. Oemeta’s non-cytotoxic neat machining oils, water-miscible coolants, and cleaners contribute to the biocompatibility of the production process. Or in other words: You do not have to eliminate cytotoxic ingredients if you do not introduce any to the process!

The US FDA, the European MDR, the Chinese NMPA, and others regulate the global quality management of medical devices and parts. A significant milestone in the qualification of any new and existing medical manufacturing is the non-cytotoxicity of the process fluids.

Oemeta has an extensive product portfolio of oils, coolants, and a cleaner that pass the test acc. to EN-DIN 10993-5 (Cytotoxicity), and that can be used on the most demanding operations, as well as in standard applications with great cleanliness and excellent efficiency.

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And finally:

A coolant is only as good as the consulting and service provided by the manufacturer or it’s representatives. Feel free to ask Oemeta for optimisation potentials or process consulting.

Contact:

Oemeta Chemische Werke GmbH Hinrich Voss Ossenpadd 54 D-25436 Uetersen