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Medical Device Cleanrooms

Medical Device Cleanrooms typically are built in the class 10,000 and 100,000 range.  The manufacturing process of these products is to ensure that the surface of the product does not have particulate and contamination on them when completed.  Typical medical device process includes final packaging of the product for use to an end user.  It is important that cleanliness level be maintained both from a cleanroom stand point and a personnel protocol stand point.  People being the major contaminator in most processes pharmaceutical, bio tech and microelectronics industries have gone to full gowns, booties, gloves, and hairnets.  Medical device cleanrooms at class 100,000 and class 10,000 tend to not have as strict protocol using smocks, hairnets, booties, gloves etc.  Medical device cleanrooms tend to look to eliminate surface contamination on their products.

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