Sterile Medical Devices

The FDA does not care about the size of your production. However, sterile products are not necessarily sterile throughout the production process, if the product characteristics allow, can be processed first in the ordinary environment, and finally cleaned in a clean room, packaging, and then sterilized, but in the ordinary environment of the production, packaging and then sterilized is not allowed, because the initial contamination bacteria out of control. If the production is small, can only minimize the scale of aseptic control.