T
A slightly different question, but related to the topics in this thread: I have always worked for sterile, surgical medical device (non-implant) manufacturers. The companies I have worked with certify their cleanrooms to ISO class 8 and I know what it takes to do that.
I am now with a new startup and in charge of setting up the cleanroom. I was going to default to ISO class 8, but what really tells me what type of environment I need? I don't believe ISO 14644 tells me that since I manufacture a certain product that I need to be a certain class, does it?
So, what should I shoot for? Is a certified cleanroom required? Would FDA or ISO look down upon a non-certified "controlled environment" assuming my product appears clean and meets bio and pyrogen requirements? Any input would be appreciated.
- TK
I am now with a new startup and in charge of setting up the cleanroom. I was going to default to ISO class 8, but what really tells me what type of environment I need? I don't believe ISO 14644 tells me that since I manufacture a certain product that I need to be a certain class, does it?
So, what should I shoot for? Is a certified cleanroom required? Would FDA or ISO look down upon a non-certified "controlled environment" assuming my product appears clean and meets bio and pyrogen requirements? Any input would be appreciated.
- TK
