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Classification of Clean Rooms

mpfizer

Involved In Discussions
#1
Hi,

We constructed a class 1000 / ISO class 6 / class B clean room , we have the following problem

As per ISO 14644 -1 2015 Table 1 the 5 micron particle size limit is 293. All the FDA and EU GMP Annex 1 state that for classification ISO 14644 has to be followed , so the room is tested for air cleanliness for 5 micron particle size and is considered as passed if the count is less than the limit as specified in Table 1 of the standard.

Now as far as the routine monitoring goes as per EU GMP Annex 1 for 5 micron at rest the count should be less than 29 and it is stated that classification and monitoring are different.

So now when we classify the count is at say 125 and it will be considered as passed as the count is lower than 293 as per ISO 14644 but who will we ever get the count to pass EU norms while routine monitoring ?

Actually it should have been reversed that is for classification count should have been at 29 and monitoring at 293

What am i missing out on ?

Any help would be highly appreciated.

Regards
michelle
 

indubioush

Quite Involved in Discussions
#5
Maybe I'm not understanding your specific questions. Please clarify.

As for the ISO Class, your clean room may be in a different classification during its operational state.
 

mpfizer

Involved In Discussions
#6
Maybe I'm not understanding your specific questions. Please clarify.

As for the ISO Class, your clean room may be in a different classification during its operational state.
For classification as per ISO 14644 -1 2015 the table does not differentiate between at rest or in operation so as per this standard the clean room is classified as a class 1000 / ISO class 6 / class B clean room BUT while monitoring it will shift to a lower class as per EU GMP !!

Can the Table 1 of ISO 14644- 1 2015 be followed for monitoring also ?? if NOT is there a relevant table we can follow in ISO system for monitoring ?
or has it to be EU GMP ?

Sorry if i appear to be confused

Thanks
 

indubioush

Quite Involved in Discussions
#7
Per ISO 14644-1, clean room classification is associated with the occupancy state. You could have a different classification during the at rest and operational states. Your Grade A clean room will be an ISO Class 5 when it is "at rest." It may be an ISO Class 7 when it is "in operation."

Regarding monitoring, it is up to you to determine the monitoring parameters that are specific to your clean room. You can follow ISO 14644-1 for monitoring if you want. You also need to define the frequency of reclassification.
 

mpfizer

Involved In Discussions
#8
Per ISO 14644-1, clean room classification is associated with the occupancy state. You could have a different classification during the at rest and operational states. Your Grade A clean room will be an ISO Class 5 when it is "at rest." It may be an ISO Class 7 when it is "in operation."

Regarding monitoring, it is up to you to determine the monitoring parameters that are specific to your clean room. You can follow ISO 14644-1 for monitoring if you want. You also need to define the frequency of reclassification.
Are you saying that for the purpose of classification as per ISO 14644-1 2015 we have to classify wrt occupancy state and we have to classify for as built, at rest, and in operation ( all three separately )? and that it can be different for all three as the limits given in Table 1 does not differentiate between the three ... seems rather odd

is there an ISO standard for monitoring of clean rooms ?

Thanks
 

Al Rosen

Staff member
Super Moderator
#9
Are you saying that for the purpose of classification as per ISO 14644-1 2015 we have to classify wrt occupancy state and we have to classify for as built, at rest, and in operation ( all three separately )? and that it can be different for all three as the limits given in Table 1 does not differentiate between the three ... seems rather odd

is there an ISO standard for monitoring of clean rooms ?

Thanks
Yes, ISO14644-2, Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
 

indubioush

Quite Involved in Discussions
#10
Are you saying that for the purpose of classification as per ISO 14644-1 2015 we have to classify wrt occupancy state and we have to classify for as built, at rest, and in operation ( all three separately )? and that it can be different for all three
Yes, it can be different for all three. Classification of a clean room is always associated with the operational state. It is up to your organization to determine whether you need to classify your clean room in one, two, or all three operational states.
 
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