Medical Device Cleanrooms
Medical Device Cleanrooms
No one understands the need for a controlled manufacturing environment better than medical device manufacturers. Medical device cleanrooms are extremely effective at preventing medical product contamination, providing significant time, energy, and cost savings.
At Cleanrooms by United, we work closely with our customers to create custom-designed medical device cleanrooms that are built to their exact specifications. We offer a wide range of medical device clean room options that enable our customers to choose the configuration that works best for their facility, employees, and their bottom line.
Contact us for more information regarding our medical cleanroom options or call us at 800-959-0878 and we will gladly answer any questions that you may have. From concept to certification, our medical cleanroom turnkey offering covers the entire cleanroom design and construction process. Cleanrooms By United is your trusted source for advanced quality cleanrooms for medical device manufacturing.
What is a Medical Device Clean Room?
Cleanrooms for medical device manufacturing provide a controlled environment that is suited to your exact application requirements. The clean room environment helps to ensure that the medical applications remain under controlled contamination levels throughout the production process. Every medical device clean room that we custom build is manufactured to your application’s ISO class specifications needs.
Medical Manufacturing and Assembly Cleanroom Case Studies
Learn how Cleanrooms By United can solve the issues presented by medical device manufacturing. Here are just a few of our medical device cleanroom case studies:
- Face Shield Manufacturing
- General Medical Device Assembly
- Catheter Assembly Cleanroom
- Medical Device Assembly with Gowning Room
Custom Medical Device Clean Room Design Specifications
Custom cleanrooms for medical device manufacturing must fulfill certain system design requirements to qualify as a specific ISO class medical cleanroom. Our custom cleanrooms are rated at a minimum of ISO 7. If you require a cleaner environment, our design experts will create a medical device clean room to your exact specifications. Medical device clean rooms require several types of precautionary measures to limit the number of particles that enter the medical cleanroom, these include:
- Product pass thrus
- HEPA fan filters
- Heat welded vinyl or epoxy floors
- Gowning atrium
- Air locks
- Air conditioners
- Entrance and exit sticky mats
- Sealed lighting
- Bunny suit, booties, and hood requirements
- Stainless steel bench and hands free sink
Wall and floor-mounted pass-thru chambers make it possible to bring items in and out of cleanrooms without the risk of contamination. An interlock mechanism prevents both doors from being open at the same time, thereby preventing any external contaminants from entering the cleanroom. Pass-thru chambers make quality control simple.
At Cleanrooms By United, our experts will work with you to design a medical device clean room that matches your exact requirement needs.
Custom Medical Cleanroom Design Options
At Cleanrooms By United, we design our medical cleanrooms with a custom layout that fits within your facility’s footprint. Our cleanrooms for medical device manufacturing are available in a wide range of sizes, including walls in excess of 30 feet for applications that involve oversized machinery. We also help medical device manufacturers to achieve and maintain Federal standards for a wide range of processes, including injection molding, medical device production and medical device packaging. Additional options for cleanrooms for medical device manufacturing include:
- Lighting options
- Electrical options
- Ceiling grids
- Air showers
- HVAC systems
- Fire suppression
- Guard rails
- Magnehelic pressure gauges
- Ultraviolet safe windows and lighting
- Epoxy painting
- High speed roll up doors
- Raised access flooring
- Compressed air fittings
Automated Control Systems
We also offer full automated control systems. A control system is designed to control HEPA or ULPA FFUs (Fan filter Units) from an automated remote console or panel. Automated Control Systems (ACS) feature mounted controllers, CAT 5 cabling, and LED readout. ACS provides both global and individual fan speed on FFU modules.
Benefits of Medical Device Cleanrooms
- Perhaps the greatest benefit of modular cleanrooms is that they can be modified or even relocated with minimal expense and downtime. Many prefabricated modular cleanrooms are almost 100% reusable.
- In general, modular cleanrooms from are far less expensive than standard sheetrock construction, and can be installed in just a fraction of the time.
- Many prefabricated cleanrooms are factory-cut, with prewired UL-classified raceways that provide a flush interior surface for electrical outlets and phone/data wiring. These raceways can also be used as service chases to house deionized water, compressed air, or nitrogen lines. Built-in raceways eliminate the mess of cutting and sanding drywall on site, and minimize construction time and facility disruption.
- Many modular cleanrooms feature an insulated wall system that provides a thermal barrier and improves the efficiency and performance of the cleanroom’s mechanical system. This reduces energy costs and maintains temperature levels far better than non-insulated systems.
- Depending on the classification level or function of a cleanroom, entry and exit through anterooms and/or gowning rooms may be required. Many modular cleanrooms can be built with accommodations for these rooms to reduce contamination from external environments. Airlocks, air showers, and pass-through boxes can be integrated so that personnel, products, and materials can be safely brought into and out of the cleanroom space without the risk of contaminant infiltration.
Discover Cleanrooms By United for Medical Device Cleanrooms Today
Cleanrooms By United is your trusted source for premium, high-efficiency medical device clean rooms.
Contact us for more information regarding our cleanrooms for medical device manufacturing, request a quote to get started, or call us at 800-959-0878 and to discuss your specific cleanroom requirements or questions.