Cleanrooms for Medical Device Manufacturing

Medical Device Cleanrooms

Hospitals are not the only healthcare entities that require controlled environments. Medical device manufacturers utilize medical cleanroom facilities during production and testing processes. People who work in medical device manufacturing are required to don full gowns, booties, gloves and hairnets to prevent contamination of the devices. Protecting the product’s surface to prevent impurities that may contaminate patients is imperative.

Meeting Stringent Specifications

Medical device manufacturing is subject to the requirements in ISO 7 and ISO Class 8. The goal is to prevent airborne particulates from contaminating the surface of the device, and to ensure that the devices are protected from potentially harmful temperature and humidity fluctuations during production and final packaging.

Quality Cleanrooms from CE

CE is an experienced, full-service cleanroom design/build company. We offer professional consulting, design, engineering, construction, project management and certification services. Whether you’re seeking a single service or a complete turnkey solution, look no further than CE. No matter how simple or how complex, your medical cleanroom project will be executed to your satisfaction, on time and on budget.

Using modular construction techniques, CE moves rapidly from the planning stage to on-site installation. Your controlled environment is built with pre-engineered components and easy-to-clean materials that ensure compliance with your specific requirements. We install your necessary equipment and furnishings, and engineer and install air flow, filtration and monitoring systems to control and measure the levels of airborne contaminants.

We also offer verification and certification services as well as cleanroom products and supplies. CE is truly the single-source vendor for medical device cleanrooms.