Advanced Cleanroom Microclean (ACM)

MEDICAL DEVICE MANUFACTURING

MEDICAL DEVICE CLEANROOM DESIGN

MEDICAL DEVICE ISSUES

There are important differences between cleanrooms for medical device manufacturing purposes and those for the manufacturing of optical products, semiconductors, or any other electronic devices not intended to penetrate the skin or interact with the body. Medical device cleanrooms must be designed to control both airborne particles, which are the nemesis of hard drives and microchips, as well as microorganisms that must be controlled to prevent the risk of contamination and thus ensure patient safety. For example, the cleanroom in which medical OEMs produce spinal implant technologies must display extremely low bioburden rates, as well as a restricted amount of airborne particles.

Faced with an increasingly regulated industry, some medical device manufacturers are forced to upgrade or build a new cleanroom to comply with the new standards. Initially driven by the semiconductor industry, cleanliness standards are now starting to be designed specifically for the medical device industry. The type of devices being manufactured will determine the cleanliness level the cleanroom must meet. For example, complex Class III medical devices face some of the most stringent quality requirements in the industry.