Medical Device
The safety of medical devices for patients is the full responsibility of the manufacturer. Cleanroom and controlled environments play a key role in medical device manufacturing.
While the primary focus of the guidance is on cGMPs in 21 CFR 210 and 211, considerable attention has been given to environmental control. USP <1116> ("Microbiological Evaluation of Clean Rooms and Other Controlled Environments") also offers device manufacturers guidance that can be used as a framework for development of their environmental monitoring plans.
As an experienced solution provider, we will offer services covering the full range of requirements for effective environmental monitoring and help you get the products you need, to meet stringent contamination control demands for any grade cleanroom at your various sites.
While the primary focus of the guidance is on cGMPs in 21 CFR 210 and 211, considerable attention has been given to environmental control. USP <1116> ("Microbiological Evaluation of Clean Rooms and Other Controlled Environments") also offers device manufacturers guidance that can be used as a framework for development of their environmental monitoring plans.
As an experienced solution provider, we will offer services covering the full range of requirements for effective environmental monitoring and help you get the products you need, to meet stringent contamination control demands for any grade cleanroom at your various sites.
