To properly manufacture and assemble medical-grade products, many companies seek clean room and white room injection molding and assembly services. Molded Devices Inc. helps medical device companies meet their specific design and manufacturing goals, offering ISO class 7 & 8 clean room injection molding and assembly services, along with white room injection molding and assembly services. The type of medical device you require will determine which environment is right for your product. Medical devices are divided into classes I-III, with class I posing the lowest risk to the patient. While there is some overlap, it is generally safe to say that the higher the medical device class, the lower the clean room class. Use this quick reference to help match up your medical device type and class with the ideal manufacturing environment.
ISO 7 Clean Room
Our highest level of sanitary injection molding and assembly services for medical devices, ISO 7 clean rooms must maintain a filtration level of 10,000 particles per square foot of air. Strictly controlling the temperature, pressure, and humidity levels within this cleanroom environment ensures the air space is free of any contaminants, dust, or particles that could impact the functionality or sanitation of the medical device. Some common examples of medical devices produced using ISO 7 clean room standards include stents, implanted prosthetics, catheters, medical balloons, and intravenous infusion pump systems.
ISO 8 Clean Room
The next clean room we offer adheres to similar levels of cleanliness, maintaining a filtration level of no more than 100,000 particles per square foot of air. This clean room is commonly used to produce injection molded medical devices like catheters, syringes, surgical equipment, medical prep equipment, and various medical housings and casings for equipment. Having both ISO class 7 and 8 manufacturing rooms, we can oftentimes manufacture, assemble, and package your medical devices in-house.
White Room Manufacturing
47% of medical devices on the market fall under class I – the least risk to the patient. Additionally, 95% of them do not need to meet strict regulatory requirements for clean room manufacturing. To help reduce cost, while still achieving an exceptionally clean production environment, we also offer white room manufacturing for medical devices like dental equipment, x-ray equipment, latex gloves, and surgical masks. These environments also help keep the production space clean through strict control over air pressure, temperature, and humidity, without strict regulations they must meet. By offering our ISO Class 7 & 8 clean room injection molding and assembly services, along with white room injection molding and assembly services, we help companies best match their product to the ideal environment.
Our team of experienced designers and engineers is ready to take on your next medical device project from concept to final packaging. MDI is proud to offer comprehensive medical device production services that allow our customers peak flexibility, and the ability to custom design the best product in collaboration with our team. Call us today at 1-800-211-9897, or use our contact page and we will respond within one business day to begin helping you with your project needs.