Medical Device Manufacturing in Controlled Environment? How to decide?

C

Cardinal Fan

Looking for guidance on how to decide if your medical device under development requires a controlled environment and/or clean room for manufacture? Sterility is not required. Thank you!
 

somashekar

Leader
Admin
Looking for guidance on how to decide if your medical device under development requires a controlled environment and/or clean room for manufacture? Sterility is not required. Thank you!
Hi Cardinal Fan ... Welcome to the Cove ~~~
Contamination control and clinically clean environment could be your basic criteria along with temperature and humidity control of the environment depending upon the type of your medical device.
Any good article or book about good manufacturing practices could give you the guidance.
"Clinically clean" is a very broad word and often used without any definition. I hope the attachment here can give you some insight / guidance
 

Attachments

  • STERILE_NEW.PDF
    70 KB · Views: 243
Top Bottom