Hi everyone!
I am a consultant with a very strict cleanroom background. I have a foreign medical device manufacturing client that makes products for the US market (therefore 21 CFR 820 compliance is required). This client has a cleanroom that is ISO 14644 Class 8 / Fed. Std. 209E Class 100,000 (non-certified).
The components they make in this room is not sterilized / does not require sterilization down stream of the process and does not require any special ESD safety equipment / measures. They must perform decreasing steps before the cleanroom.
They just want to control particles (not even minding the type of particles) that come in contact with the sub-components.
However, they do not use gloves.
I am concerned they are negating the whole purpose of using the cleanroom by human factors. We are in the process of validating processes that take place within the cleanroom but haven't executed any protocols as of yet.
Am I worrying too much over nothing? Like I said, my cleanroom background is of a much stricter class.
Any thoughts would be greatly appreciated!
I am a consultant with a very strict cleanroom background. I have a foreign medical device manufacturing client that makes products for the US market (therefore 21 CFR 820 compliance is required). This client has a cleanroom that is ISO 14644 Class 8 / Fed. Std. 209E Class 100,000 (non-certified).
The components they make in this room is not sterilized / does not require sterilization down stream of the process and does not require any special ESD safety equipment / measures. They must perform decreasing steps before the cleanroom.
They just want to control particles (not even minding the type of particles) that come in contact with the sub-components.
However, they do not use gloves.
I am concerned they are negating the whole purpose of using the cleanroom by human factors. We are in the process of validating processes that take place within the cleanroom but haven't executed any protocols as of yet.
Am I worrying too much over nothing? Like I said, my cleanroom background is of a much stricter class.
Any thoughts would be greatly appreciated!