Medical Device Cleanrooms

Cleanrooms for Medical Device Manufacturing & Packaging

Medical Device manufacturing and packaging regulations and requirements are complex and compliance critical. Based on your medical device business, products and manufacturing processes, the Precision Environments’ team of expert engineers will propose the precise Medical Device cleanroom environment to comply with all requirements and ensure successful business operations. Our Medical Device cleanrooms are certified to meet or exceed the required classification conditions in accordance with Federal Standard 209E and ISO 14644.

Temperature, pressure, and humidity are highly regulated and air is repeatedly filtered to protect your products and packaging from contamination. Our ISO 14644 calibrated Medical Device cleanrooms control the introduction, generation, and retention of particulate, protecting your products and processes from airborne and/or human-borne contaminants, thereby reducing risk of harm to patients or end users