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ISO 14644-3 - Testing Air for Particle Counts

ISOsandy

Inactive Registered Visitor
#1
Can anyone help me get a copy of ISO14644-3? Any help, advice or anything would be helpful!

We are trying to test air for particle counts... not sure on the testing methods, formula's ect (new to clean rooms) so I am completly lost!! :mg:

Thanks,
Sandy
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
You'll probably have to buy a copy because we can't post copyrighted documents such as ISO standards here, but do you have a specific question?

For reference:
ISO 14644, Cleanrooms and associated controlled environments - Part 3: Test Methods

Scope
This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining performance parameters. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this part of ISO 14644 may be used if based on agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

Background
The first meeting of WG 3 was held in 1994 in Tokyo. Initial questions faced by the working group were: what was to be included in the standard and what was to be the structure of the standard. During brainstorming sessions in the first meeting, measurements and tests related to cleanrooms were classified into three categories:

1. Measurement and test methods inherent to cleanrooms.
2. Measurement and test methods often used in cleanroom but not limited to cleanrooms.
3. Measurement and test methods of a general nature.

As cleanrooms include all phases of the engineering sciences, the measurement and test methods related to cleanrooms were numerous. WG 3 was requested by ISO/TC 209 to use the following policy to decide which items to include in the document:

1. If there are any previously established standards on the subject, refer to them.
2. Include items according to the requests or needs of other Working Groups.

The most important objectives of this document are to provide an internationally common basis of measurement and evaluation of cleanrooms and, at the same time, not to prevent the introduction of new technologies. The latter is the reason that the part of this Standard related to instrumentation is Informative. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-3:2005 in the United States.
 

ISOsandy

Inactive Registered Visitor
#3
Well, let's see... Like I said, this is all new to me, I have a particle counter and am unsure how to evaluate and take my readings. I also have the microbiological counter... but particle counter first.

We will be a class 100,000 (ISO Class 8) clean room.
I am unsure how to perform the calculations, how many samples to take per area, the sample time/length, and how to interpret it all. I know I need to find the air exchange rates, cubic meters, etc... not sure how to tie it all in and report it correctly.

I hope that made sense... It is Monday and this is driving me batty!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
ISOsandy, do you have a manual for your particle counter?

If not, I've tried to find them online but I expect you'd have better results by contacting the manufacturer or supplier for a copy. They might also have other materials for you to use. Please take your unit in hand (with its model number and serial number) and call them so you can get direct help that can be imported to work instructions or kept in your files.

If you can give us the make and model number of your tester maybe we can help find your formulas.
 

ISOsandy

Inactive Registered Visitor
#5
ISOsandy, do you have a manual for your particle counter?

If not, I've tried to find them online but I expect you'd have better results by contacting the manufacturer or supplier for a copy. They might also have other materials for you to use. Please take your unit in hand (with its model number and serial number) and call them so you can get direct help that can be imported to work instructions or kept in your files.

If you can give us the make and model number of your tester maybe we can help find your formulas.
I have the manual, know how to operate the unit. However, how do you perform the calculations? What are the sample sizes (qty of readings taken at each designated area) and how long should the readings be (2 min, 5 min)...

I know I need the exchange rate, however for ISO CLass 8, in given so many cubic meters of area, what is the sample size? Proximity of samples and qty at each location? Testing time? And then finally, calculation?

It is not as simple as take your particle counter, get some readings, and go with it, at least not as far as I have researched so far.

The counter has multiple settings, and you can place it anywhere, take any number of readings. The manual doesn't get into requirements/methods/calcualtions, just how to operate the equipment.

Thanks for the advice though!
Sandy
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
Sandy, I did a Google search using words "procedure particle count clean room class 8" and found these sources for you:

http://www.pmeasuring.com/support/papers/particlemonitoring/pharmaceutical/app41/viewHtml
http://www.particlecounters.org/blog/iso-14644-cleanroom-validating-to-iso-class-8/
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1455

If my links do not give you what you need, please perform the Google search again (might want to include the term "ISO" in your search words) and open the links until you access the needed process guidance.

I hope this helps!
 

BradM

Staff member
Admin
#7
Hello!

Have you considered having a contract service come in a perform this? That is their business, and they are usually quite familar with the classifications and the documentation. That may give you a start. This is NOT to suggest that you are not competent, or you can't do your own test. It just sounds like you may be getting down to 'crunch time'. The money spent (given you pick a good certification company) will be well worth it to give you a start. Too, if you are seeking some industry approval, using a reputable certification organization may be a plus.

1. Are you just testing the room for particle classification, or do you have HEPA filters you are also going to test? Filters are another fun ballgame.

2. Did you build your own cleanroom, or did someone build it for you? If someone built it for you, they should have given you some documentation to support the classification.

3. If you built it yourself... NOTE: Without making modifications, the room will be what it is. It may or may not meet your specifications.

As far as the calculations, most of the more current particle counters already have printouts/algorithms to present the criteria for the classifications. As Marc pointed out, you really should purchase the copy of the specification.

Also, particle testing should occur while activity is being conducted in the room, to simulate the actual generation of particles.

Just some thoughts. Good luck, and repost if there are more questions.
 

ISOsandy

Inactive Registered Visitor
#9
Thanks for all of the information!

The situation is, this company was purchased and moved to Ohio. So we are re-doing everything in the new facility. We have all of the equipment to perform the tests, I am just not familiar with all of this.
I am trying to go back through the old files, SOP's and documents to see exactly what was done prior, but of course it is a mess and the few employees that stayed with the move are not cooperative.:mad:

The company has already made the decision to handle this with our team. We had the room designed and built from a contractor and I am waiting for all of the information on that. Just wanted to get my head straight and on the right path before I really have to get this completed.

We do have the HEPA filters, plus like 4 additional filter types... so it is a bit much.

Thanks again!
Sandy
 
Last edited:

BradM

Staff member
Admin
#10
Good luck to you!

Please do repost and let us know how your progress goes. It is such a good learning experience to read about the initial challenge, how you dealt with it, lessons learned, etc. It takes great humility to do that, but all benefit from it.

I hope that your particle count readings get you two classes better than what you need!:bigwave:
 
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