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Cleanrooms - Particle Measuring - ISO 14644

SMBIZZQA

Starting to get Involved
#1
We have a controlled environment, not a classified clean room, however we have been doing environmental checks, ie. particular monitoring. I have determined that based on the room size that I need to do 25 locations and in the past have been collecting 5 readings per location. Is the number of readings overkill, can I reduce the umber per location or is 5 reasonable?
Thank you!
 
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htcoztrk

Starting to get Involved
#2
Our company is operating cleanrooms classified as ISO 6 and ISO 7 so I do not know about the controlled rooms that not classified as cleanroom. However I wanted to share my opinion in case it helps.
May I ask why do you collect 5 readings per location? We are outsourcing the all cleanroom testing to accrediated labs and we have been collecting 1 reading of various sizes of particles (0.3, 0.5, 1 and 5 um) per sampling locations for many years. One reading per location has not been any issue on our surveillance audits by neither national nor international auditors and technical experts.
As I recall there is no requirement for minimum reading in ISO 14644-1:2015 but there is minimum sampling location number requirement. You can check the Annex A.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Howdy,

For a room not classified/certified as a cleanroom, you don't HAVE to do anything. So I'm not sure the basis of the question.

For my ISO8 (100K) and ISO 7 (10K) rooms in the past, one reading was done per location by an outside body as per the previous post above. This was done once per year.

If you want more data, you'll get more usable data measuring the room more often than you will measuring 5 times in a row in the same day.

Given the choice between 5 measurements the same day each year, vs. one reading per location each quarter...I would take the quarterly (it would cost more, though).
Sampling the room once in full usage condition will tell you all about the room...measuring it again 2minutes later gives you no additional useful data unless the first reading is way outside of expectations.

HTH
 

SMBIZZQA

Starting to get Involved
#4
Thank you for the responses. To answer your questions, the reason I was collecting 5 readings per location was to collect enough data to determine some action and alert levels. I guess that isn't necessary.
Even though we are not a classified room, because we do produce product that is further processed and sterilized we need to run under Controlled Environment. It was suggested by a Microbiologist auditor that I split my area into 3 sections and do one section per month, which is what I have been doing.
I guess that I can reduce the number of readings, which will certainly save a lot of time!
:thanx:
 
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