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Medical Device Cleanrooms

Medical Device Cleanrooms

At Kwang Cleanroom, we work closely with our customers to create custom-designed medical device cleanrooms that are built to their exact specifications.

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 Kwang Cleanroom, 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 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. Kwang Cleanroom 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.

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 thru’s

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

Pass-Thru Chambers

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 Kwang Cleanroom, 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 Kwang Cleanroom, 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

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.

Contact Kwang Cleanroom for more information on the benefits of modular cleanrooms. Have questions? Call us today.

Discover Kwang Cleanroom for Medical Device Cleanrooms Today

Learn how Kwang Cleanroom can solve the issues presented by medical device manufacturing. Kwang Cleanroom is your trusted source for premium, high-efficiency medical device clean rooms.

Contact us for more information regarding our cleanrooms for medical device manufacturing or call us and we will gladly discuss your specific cleanroom requirements.

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