Clean rooms for medical devices

The requirements for production of medical devices is going to get more stringent and comprehensive due to imminent regulations; as is the case in Europe, Australia and the USA. The cleanliness requirement of the environment and facility will be dependent on the type, stucture and format of the medical device, it’s packaging and manufacturing process. This is where clean room design, layout and validation is becoming more applicable. To quote WHO “– clean area – An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.”

 

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