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AS NUR

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Posted 01 July 2008 - 01:52 AM

Dear All... :helpplease:

Yesterday my Organizatiion was surveillance audited for ISO 22000 ... and I have heard from ISO 22000 auditor, that Plate Count Agar is not suitable for Cleanroom monitoring.. Is that right? is anyone have literature what is media that suitable for clean room monitoring?

Thanks


AS NUR



cazyncymru

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Posted 01 July 2008 - 01:11 PM

Dear All... :helpplease:

Yesterday my Organizatiion was surveillance audited for ISO 22000 ... and I have heard from ISO 22000 auditor, that Plate Count Agar is not suitable for Cleanroom monitoring.. Is that right? is anyone have literature what is media that suitable for clean room monitoring?

Thanks


AS NUR



Hi AS NUR

i use a number of different things for environmental monitoring.

The products that i am involved with in manufacturing are suceptiple to spoilage by yeast and moulds, so i used Rose Bengal pour plate, which i leave out for 1 hour, to monitor Y&M levels in our packing rooms.
I also use Nutrient Agar to monitor the air quality, especially around the filling heads, using the same principles (open plates for 1 hour)

Both of these i do weekly, with counts that are greater than 100 on the Y&M resulting in a fogging clean being instigated.

also i do environmental swabbing of plant and environment for listeria (Salmonella isn't a problem for us, but it is in dried products), which we do monthly and are sent away for testing.

Also, we plate out swabs for entro's, Staphs and Bacillus on a monthly basis, in tandem with hand swabs for the operators, to monitor the effectiveness of their hand washing.

hope that helps

C x


Simon

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Posted 02 July 2008 - 08:10 AM

Hi AS NUR

i use a number of different things for environmental monitoring.

The products that i am involved with in manufacturing are suceptiple to spoilage by yeast and moulds, so i used Rose Bengal pour plate, which i leave out for 1 hour, to monitor Y&M levels in our packing rooms.
I also use Nutrient Agar to monitor the air quality, especially around the filling heads, using the same principles (open plates for 1 hour)

Both of these i do weekly, with counts that are greater than 100 on the Y&M resulting in a fogging clean being instigated.

also i do environmental swabbing of plant and environment for listeria (Salmonella isn't a problem for us, but it is in dried products), which we do monthly and are sent away for testing.

Also, we plate out swabs for entro's, Staphs and Bacillus on a monthly basis, in tandem with hand swabs for the operators, to monitor the effectiveness of their hand washing.

hope that helps

C x

Caz do you also do accelerated shelf life trials in a heated room on samples of finished product? I think this is standard for dairy??

Regards,
Simon

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AS NUR

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Posted 02 July 2008 - 08:43 AM

hi Caz.... Thanks for your information.. Do you have any reason or literature why you use nutrient agar to monitor the air quality?
... actually i am now using PCA to monitor air quality.. the reason is PCA is Commonn agar to evaluate Micro Growth... but during the ISO 22000 Audit, the auditirs Ask me to show the literature to convince them that PCA suitable for Air quallity monitoring...



a_andhika

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Posted 04 July 2008 - 11:31 AM

hi Caz.... Thanks for your information.. Do you have any reason or literature why you use nutrient agar to monitor the air quality? ... actually i am now using PCA to monitor air quality.. the reason is PCA is Commonn agar to evaluate Micro Growth... but during the ISO 22000 Audit, the auditirs Ask me to show the literature to convince them that PCA suitable for Air quallity monitoring...


Dear As Nur,

I am sorry I cant help you just like you did to me... coz I am a user of PCA for air monitoring too..:( If you dont mind, may I know who is your ISO 22k Auditor? I am going to face certification nearly.. so who knows I might get similar troublesome thing like yours...

You may try this linK:
http://www.moldbacte...ia_testing.html
On that link, the media for quality air monitor is using TSA and NA (I guess it just the same as Caz)... But in my opinion, the purpose of PCA is to count the Aerobic Bacteria, right? So I think, it wont be a problem if you (read:we) use the PCA to monitor the Air Quality, because we are counting the bacteria that live in the air, right? (I smells a self-justification here...) Besides the PCA, I am using YGCA to monitor the Yeast and Mold in air. They (PCA and YGCA)showing a good result, and I am sure it resemble the actual condition (uh-oh.. the self-justification is getting worse..).

Perhaps you would look after for this one too:
http://www.cfsan.fda...ebam/bam-3.html
This is the quote from that link: "The microbial density of air in working area, measured in fallout pour plates taken during plating, should not exceed 15 colonies/plate during 15 min exposure." It only said "fallout pour plates", not mention the media. IMHO... PCA is a pour plate agar, so.. why not? (thats it.. I am outta here!)

I hope that would gives you a hint (or a confusion). I really really hope that my auditor wont ask those things...

Regards,


Arya

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safety and quality means perfection
AND
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why should I bother?

AS NUR

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Posted 07 July 2008 - 04:08 AM

Dear All...

Thanks for your help and support... actually now I got the answer from MERCK Literature (MAS 100 Product Description) .. That document State that PCA can use for air monitoring...

.. To Arya.. dont worry about audit... last month we audited by SAI GLOBAL... And hopelly ur audit success

Thanks


Asep S Nur



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Posted 10 July 2008 - 09:38 PM

Caz do you also do accelerated shelf life trials in a heated room on samples of finished product? I think this is standard for dairy??

Regards,
Simon


Yes we do

there is the Hannah test, where we abuse the sample and test on DOM and also we do end of shelf life testing, where we abuse the samples during the last 4 days




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