Cleanroom environments used for the production of medical devices are expected to meet the design specifications detailed in ISO 14644-4, Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up, and ISO 14644-5, Cleanrooms and associated controlled environments - Part 5: Operations. The control of microbial contamination in cleanrooms is expected to meet the requirements of ISO 14698, Cleanrooms and associated controlled environments - Biocontamination control, as well as Good Manufacturing Practice (GMP) Guidelines.
Medical device manufacturers face a number of challenges when designing and operating a state-of-the-art cleanroom environment. Often, the cleanroom design fails to meet the specifications required by the manufacturer and the requirements of the product being produced. In other cases, the manufacturer’s monitoring program is insufficient to quickly detect contamination problems when they can still be addressed, or before products have been released. In addition, medical device manufacturers may require evaluation of their cleanroom facilities when expanding their production lines. These and other challenges potentially compromise the quality of the devices being manufactured and expose patients to potential safety risks.