When manufacturing medical components, every care must be taken to ensure the medical component is hygienic, safe and suitable for performing the task it was designed to do. As part of this process, Hudson Technologies, a leading U.S. green manufacturer of deep drawn metal enclosures, or cases, and stampings, including metal diaphragms, has implemented a rigorous quality management system that ensures all manufactured parts comply with all standards.
Here are the top 3 priorities when manufacturing deep drawn medical components. Always ensure your deep drawn manufacturer can supply these things.
Keeping Medical Components Clean
During the process, it is essential that components are kept clean and hygienic. No chlorinated lubricants or solvents are used in our TCE-free manufacturing process, producing no hazardous waste. Still, to ensure proper cleanliness, all fluids used must be safe and special cleaning processes used to remove all traces of fluids and manufacturing debris that remain after manufacture. After thorough cleaning, components will be carefully packaged to prevent contamination.
Having Precision Equipment
Whether parts are to be used in medical equipment or for implanting, manufacturing tolerances must be maintained to ensure the components will fit exactly and work as intended. To ensure precision, we have:
- ISO Certified Quality Management Systems: ISO 9001:2008 and ISO 13485:2003
- Advanced quality planning and inspection
- OGP Smart Scopes – touch, laser and optical measuring capabilities
- Material and process traceability
Obtaining a Quality Surface Finish
One of the best methods of ensuring a medical component is hygienic is to specify a very high-quality surface finish. Highly polished surfaces with no defects can be readily sterilized and it gives infections nowhere to take hold. It is important to ensure tools and dies being used have a good surface finish and are well maintained. This way, parts coming off the press have high-quality internal and external finishes. From there, subsequent finishing processes can achieve the specified finish.