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bioburden, cleanrooms
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  #1  
Old 12th March 2009, 03:07 PM
carlosandrosie carlosandrosie is offline
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Please Help! Establishing alert and action limits for clean room bioburden

Hello everybody.

Even though I've been a member of the forum for a while this is actually my first post...

I'm looking for some insight on how to determine alert and action limits for bioburden in our Class 8 clean room.

2 years ago we started operations and since we have been monitoring bioburden levels (among other things) on a monthly basis. Now we fill it is time to establish alert and action limits.

However, by reviewing lots of standards and doing extensive research I have been unable to find any guideline on how to establish those. I found the 50/100 cfu guideline from FDA but that specifically applies to Drug products (we are a devices manufacturer).

Also found references in USP 797 but again, that applies to drug compounding environment.

Based on my findings it seems that there is no regulatory requirement for device manufacturers other than establishing your own limits, but I want to believe there is more than just setting them somehow arbitrarily based on historic data.

Any help/advise will be greatly appreciated. Thanks in advance to everyone who stops by.

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  #2  
Old 12th March 2009, 09:06 PM
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Ajit Basrur Ajit Basrur is offline
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Re: Establishing alert and action limits for clean room bioburden

Hi carlosandrosie,

Hope to see more from you

Regarding testablishing the alert and action limits, USP 1116 would be an appropriate section. USP 1116 states "the principles and concepts of statistical process control are useful in establishing Alert and Action levels and in reacting to trends". Thiese limits also depend on the risk to your product.

In one of my previous organizations, we had set an alert of 50 cfu and action of 70 cfu against a final rejection of the product over 100 cfu.

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Old 13th March 2009, 06:24 AM
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I Say... Re: Establishing alert and action limits for clean room bioburden

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In Reply to Parent Post by carlosandrosie View Post


Based on my findings it seems that there is no regulatory requirement for device manufacturers other than establishing your own limits, but I want to believe there is more than just setting them somehow arbitrarily based on historic data.
Hi Carlos,

The guidance you are looking for can be found in ISO14698 Pts 1 & 2, "Cleanrooms and associated controlled environments - Biocontamination control". Part 1 is the guide to how to set up a system, including methods of detection, how to set effective limits and system verification. Part 2 is about the evaluation and interpretation of the data you generate. Both parts offer excellent guidance on managing levels of cleanroom bioburden.

The only true arbiter of the performance limits is you. What performance level do you need to protect your products adequately? What did you manage to acheive in the manned state during PQ or PV? Are you able to consistenly reach those levels or has the perfromance of the room wandered from the validated state?

If you are want guidance on "normal" room performance limits then Annex 1 of the EudraLex "rules governing medicinal products in the EU", Volume 4 EU guidance to GMP is the only standard I know of that spells out specific performance limits - I attach that table as a picture, but the document is freely available from the link above. The stated room grades align with the US room classifications as follows Grade A = class 100 (aseptic), Grade B = class 100 (non-aseptic), Grade C = class 10,000 and Grade D = class 100,000. Although this is a pharma standard, there is no reason that any cleanroom operating to these classifications should not be able to meet these performance limits - I believe the Grade C & D limits are very generous.

Hope this helps,

Jimmy
Attached Thumbnails
EudraLEx V4 Annex 1 micro contam table.jpg  

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Thanks to Jimmy the Brit for your informative Post and/or Attachment!
  #4  
Old 13th March 2009, 09:17 AM
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Re: Establishing alert and action limits for clean room bioburden

Jimmy, any idea why these standards aren't harmonized (under the MDD etc)?

The 14644 series isn't harmonized either.

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Old 13th March 2009, 09:37 AM
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Re: Establishing alert and action limits for clean room bioburden

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In Reply to Parent Post by Roland Cooke View Post

The 14644 series isn't harmonized either.
14644 parts 1-6 + 8 are FDA Recognized Consensus Standards, which I think implies that whatever problem exists in reaching harmonization, it probably isn't on this side of the pond.
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Old 13th March 2009, 10:29 AM
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Re: Establishing alert and action limits for clean room bioburden

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14644 parts 1-6 + 8 are FDA Recognized Consensus Standards, which I think implies that whatever problem exists in reaching harmonization, it probably isn't on this side of the pond.
ISO14698 1&2 are also FDA recognised. I have no idea why they are not globally harmonized, and wouldn't want to speculate about my European colleagues ability to agree on anything, including what to eat for lunch...

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Old 13th March 2009, 10:57 AM
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Re: Establishing alert and action limits for clean room bioburden

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ISO14698 1&2 are also FDA recognised. I have no idea why they are not globally harmonized, and wouldn't want to speculate about my European colleagues ability to agree on anything, including what to eat for lunch...

Hey, it only took us 27 years to agree on a definition of chocolate!

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Last edited by Roland Cooke; 13th March 2009 at 11:16 AM.
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Old 13th March 2009, 11:10 AM
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Re: Establishing alert and action limits for clean room bioburden

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Hey, it only took us 27 years to agree on a definition of chocolate!
The next thing you know they will be letting us buy curved cucumbers in pounds and ounces!

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