Need for a cleanroom in the manufacture of a medical device for a clinical trial

[JoselVLC]

I would be grateful if you could indicate if, in the manufacture of a medical device (IIb or III) for use in a clinical trial, it is necessary that this product is manufactured in a cleanroom.

Sincerely

 

[indubioush]

It depends on your medical device. Could the environment affect safety or performance of your medical device? Is your medical device sterilized?

 

[JoselVLC]

Thanks. The medical device that we are developing is for cardiovascular application and, of course, when used in the clinical trial, it must be sterilized. And the environment could affect safety or performance.

 

[planB]

JoselVLC,

the topic has been addressed in this thread. Have also a look into ISO 13485:2016, section 6.4, Work environment and contamination control - quotes:

The organization shall document the requirements for the work environment needed to achieve conformity to product requirements.[...]
For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes.

HTH,

 

[indubioush]

Thanks. The medical device that we are developing is for cardiovascular application and, of course, when used in the clinical trial, it must be sterilized. And the environment could affect safety or performance.

In that case, yes, it will be expected that you have a clean room and monitor your particulate per ISO 14644 and viable organisms per ISO 14698. You should also monitor your product bioburden and endotoxin.