Hi All,
For Grade D in operation it says 'Not Predetermined'   (for Grade D, in operation limits are not pre-determined. The manufacturer should establish in operation limits based on risk assessment and routine data where applicable.

Do you have to establish limits or can you justify that in operation classification and routine monitoring is not required?
Is the statement interpreted as 'The manufacturer should establish in operation limits where applicable - and we can say that we don't think applicable.  If you do think that it is applicable then you should use a risk assessment and routine data to do this?

Although this guide is scoped at sterile manufacture, however you can apply it's principle to non-sterile. I am looking at it for non-sterile pressurised metered dose inhaler manufacture where we have designated Grade D cleanroom (required by Annex 10). It is very basic and says ...comply with Grade D environment...

Thanks for your input.

Mike

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