Medical Devices Manufacturing

The manufacture of medical devices is subject to stringent and comprehensive regulations. The type of the medical device determines the cleanliness requirement of the environment. For most device classes, contamination control is achieved through the use of a clean room facility. A clean room is a controlled environment where products are manufactured, in which the concentration of airborne particles is controlled to specified limits. These contaminants are generated by people, process, facilities and equipment and must be continually removed from the air. The level to which these particles need to be removed depends upon the standards required. Strict rules and procedures are followed to prevent contamination of the product. The only way to control contamination is to control the total environment- air flow rates and direction, pressurization, temperature, humidity, specialized filtration and the sources of these particles all need to be tightly controlled. Experiments show that electric machines are inherently more suitable for medical clean room applications and in many cases hydraulic machines are equally, if not more compatible, and are able to demonstrate compliance to the most stringent ISO standards.

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