Cleanroom design and performance play an important role in the efficiency and quality of medical device manufacturing. Medical device manufacturers are under pressure to meet both efficiency and stringent quality concerns. Medical device manufacturers must bring their product to market as quickly as possible yet cannot skimp on quality, as devices must be fully compliant and approved by the FDA before they can be marketed.
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.
Time to market is critical in medical device manufacturing. Manufacturers must be ready for production as soon as possible and MECART cleanrooms can meet these short lead times with our high capacity plant and high efficiency production line. Our unique Hook & Seal system and factory engineered and prefabricated panels make our modular cleanroom installation among the fastest in the industry.
Flexibility of MECART’s modular cleanrooms
Medical device manufacturers are under pressure to meet both budgetary concerns and short lead times. With our unique modular system, you can launch quickly yet modify or expand your cleanroom later if need be.
Mecart has manufactured hundreds of cleanrooms for various industries and applications over the past four decades. With our know-how of medical devices, pharmaceutical/sterile environments, as well high technology manufacturing requirements, we are perfectly qualified to advise you on your medical device cleanroom project.