Clean Room Monitoring Plan

Lokus200

Starting to get Involved
#1
Hi all, during our last audit we had a non-conformance - we don't have a cleanroom monitoring plan. It's been 9 month since the audit and we are still struggling to put this monitoring plan together, the problem is we don't have a cleanroom expert in our company and the management are not willing to pay for consultants. Instead they gave me the ISO 14644 standards and asked to learn and understand and to create a monitoring plan.
Can anyone show me an example of how is this plan looks like? I searched the internet but can't find anything useful. I read ISO 14644 and ISO 14698 standards but I still don't understand what's required. I understand I need to put a list of tests and their frequencies and the sampling plan for the tests, if I can see the examples of how it's done this will be much appreciated. Our cleanroom is for medical device manufacturing ISO Class 7.
Thanks in advance,
Alex.
 
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P

Pezikon

#3
I attached two documents. These documents come from a place that recently passed an ISO AS9100 audit and has a class 7 clean room. I X'd out document numbers and titles that might reveal where it came from. I also removed the cover pages. The document "Monitoring of Cleanroom Airborne Particles" had images in it but I had to delete them because the file size was too big to attach. The images just gave a visual of the written steps. These files were converted from PDF, so the formatting and spelling may not have carried over correctly.
I don't know anything about cleanroom stuff, I just had access to these documents. I hope this helps.
 

Attachments

M

MIREGMGR

#4
Our cleanroom is for medical device manufacturing ISO Class 7.
Does your management "get" that this task they've handed you is mission critical? Perhaps more so than their own jobs.

Most organizations that make or package devices in a Class 7 (or 8, or whatever) cleanroom do so in order to achieve consistent (not necessarily low, just consistent) bioburden on their devices. That's because consistent bioburden is an absolutely essential characteristic of sterilization validation.

If that's true for you, the point of monitoring what's happening in your cleanroom is to know that you have an environment in which the operations you do before and in that cleanroom will result in product that does not exceed the bioburden level for which your sterilization process was validated.

So a starting point is to look at your sterilization validation. What bioburden was determined to be the worst-allowable-case? That's your absolute upper limit. You want to achieve a level that's (1) consistent, and (2) a fraction of your validation limit.

Start by taking measurements of the bioburden on your products coming out of ordinary product batches. You'll be working with an outside lab...if you don't know who does this, talk to your sterilization contractor about who they use, and talk to that lab about what methods they want you to use.

Measure with every room and production variable you think could affect production characteristics...heat and cooling on and off, filters as dirty as you allow them to get and just changed, beginning and end of each shift, different products in the room. Are all the numbers consistent? Or is there variability in what the room delivers? If there's variability, you've already learned two important things...what product and set of production circumstances is your "challenge" combination for further work on the problem, and that the room and/or your processes quite possibly need engineering evaluation and fixes.

Once you know that the room is consistent and/or you've identified your challenge combination, and you've established that the worst case situation is within the sterilization validation boundary, you can select methods of measuring particle counts in the room that are cheaper and easier to perform than product bioburden evaluations. Those cheaper easier methods become your control basis. You however need the foundation studies so that you have proved that your production room monitoring method(s) correlate with product bioburden.

Your NB's microbiologist should want to see that you have proven such a correlation, and that you understand that ultimately what you're indirectly monitoring is product bioburden.

If my surmise above as to why you have a cleanroom was correct, then if you go back to the prior NC, it should say something that you can understand to be consistent with the above.
 
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Lokus200

Starting to get Involved
#5
Thank you guys, it was very helpful. I have learned the ISO 14644 standards and I think I have an idea what to do now.

The other question is related to ISO 14698-1 paragraph 5.3.2.4 Design of a sampling plan:
This standard talks about risk zones, how I define risk zones? Is that the work stations where all the work is done or is that a zones where we have the greatest risk of contamination?

Thanks,
Alex.
 
M

MIREGMGR

#6
The other question is related to ISO 14698-1 paragraph 5.3.2.4 Design of a sampling plan:
This standard talks about risk zones, how I define risk zones? Is that the work stations where all the work is done or is that a zones where we have the greatest risk of contamination?
The latter.
 
X

xtopher_dr

#7
Hi,
Is anyone has copy of ISO 14698-1 Cleanrooms and Associated controlled environments? or Maybe details regarding this procedure.
I'm working right now on our SOP for Air Sampling, this ISO would be very helpful.

Thanks in advance
 
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