Environmental Monitoring in ISO 13485 production areas

[yuvvz]

Hi, I'm looking for a reference for environmental monitoring in our production areas. Our clean rooms follow the 14644 guidelines but for our other manufacturing area's that produce medical devices we have just decided to do air monitoring (settle plates) where we assume there is a lot of foot traffic/operations occurring. Our recent audit picked up that there is no clear rationale for where we do air monitoring. So I want to know if there is maybe a standard that specifies where you should put a settle plate per square metre in an area or is there any justification as to how many settle plates to put in a manufacturing area that is not a clean room?

 

[LUFAN]

Do you consider those non-cleanroom areas to be ISO 9 spaces? If not, that might be something to look into as there are particle concentration limits defined in ISO 14644-1 and obviously minimum sampling locations to at least tie back a rationale for doing such to.

At the very least, you could choose to adopt the Table A.1 minimum sampling locations based on the area size.

 

[yuvvz]

Technically I guess it would be seen as ISO 9 as it is a controlled environment with interlocking doors, etc.,
Thanks for the idea! I think I could even do a study where I use these sampling locations based on Table A.1 and then after doing 3 different rounds of air plates in these locations I could determine from there the worst case areas and use these for ongoing monitoring instead of all the points. We have 5 different production areas which are quite large so we try to minimize the routine work as much as reasonably possible

Thanks again!