Design Build Clean Room for Medical Devices

Precision Cleanrooms®, A division of Precision Environments, Inc. is an industry leading provider of medical, pharmaceutical, nutraceuticals and medical device cleanrooms. A recognized leader in clean room medical devices innovation, Precision Cleanrooms is a one-stop source for world-class design-build modular cleanroom services. Our turnkey offering covers the entire medical device cleanroom design and construction process, from concept to certification.

A world leader in medical device cleanroom design and construction

Medical device manufacturing and packaging regulations and requirements are complex and compliance is critical. Our team of medical device cleanroom engineers take the time to understand your business, your products and your medical manufacturing processes to propose the perfect medical device cleanroom environment to comply with all requirements and ensure successful business operations. Our medical device clean rooms are certified to meet or exceed the required classification conditions in accordance with Federal Standard 209E and ISO 14644. The temperature, pressure and humidity are highly regulated and the air is repeatedly filtered to protect your medical device products and packaging from contamination.

Built for Compliance

All cleanrooms designed, built and warrantied by Precision Cleanrooms are compliant with ISO 14644-1 standards.

Built for Compliance

All cleanrooms designed, built and warrantied by Precision Cleanrooms are compliant with ISO 14644-1 standards.

Built for Compliance

All cleanrooms designed, built and warrantied by Precision Cleanrooms are compliant with ISO 14644-1 standards.

Medical Device Clean Rooms with Guaranteed Performance

To ensure that your products remain under controlled contamination levels during your production process and packaging process, our medical device clean rooms guarantee to control and maintain temperature, humidity, pressure and contaminant levels. Our ISO 14644 calibrated medical device clean rooms control the introduction, generation, and retention of particulate, protecting your products and process from airborne contaminants or human-borne contaminants.

Medical Device Cleanroom Design and Construction

We look forward to partnering with you to design and build the perfect medical device cleanroom to fit your business needs. It is our end goal that you maximize your investment in your cleanroom environment, delivering products that are free of contamination therefore reducing risk of harm to patients or end users. Contact us today to learn more about our medical device cleanrooms.

Pharmaceutical Cleanroom

Modular Cleanroom, Pharmaceutical Cleanrooms

Semiconductor-Cleanroom

Modular Cleanroom, Pharmaceutical Cleanrooms

Bio-Pharmaceutical

Modular Cleanroom, Pharmaceutical Cleanrooms

FAQs About Medical Device Cleanrooms

Implantable medical devices come into contact with tissue and membrane. They must be sterile and contaminant free to protect the patient from infection. Implantable medical devices must be manufacture[Learn more]
Often the final step of medical device manufacturing is sterilization prior to packaging. The packaging step is often done in an ISO-5/class 100 cleanroom environment to ensure that no contamination g[Learn more]
Plastic injections molders are typically ISO-8. Supplier cleanroom requirements are dictated by the medical device company depending upon what cleaning and sterilization steps are done to the componen[Learn more]
Yes. GMP requires a controlled environment. Typically, there is some kind of medical device manufacturing specification for allowable temperature and humidity that can only be achieved with cleanroom[Learn more]
Medical device cleanrooms classification can range from ISO-5 to ISO-8 depending on the criticality of the product, whether it is implantable, and sterility requirements. Determination of correct clea[Learn more]
The FDA requires that medical devices be manufactured under FDA GMP (Good Manufacturing Practice) rules. Some medical device is subject to FDA validation which includes manufacturing processes, equip[Learn more]