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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 3 Sep 2019 14:10:29 -0400
Content-Type:
text/plain
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In terms of an action limit, if the limit was ssated as 1 CFU then 2 CFU
would exceed the limit so the limit is given as <1 CFU.

On Tue, Sep 3, 2019 at 2:00 PM Evangelia Georgiadou <[log in to unmask]>
wrote:

> Hello forum members,
>
> I came across the following statement and i would like your comments on it.
>
> *From Pharmaceutical Guidelines…*
>
>
>
> Less than 1CFU/Plate in ISO 5 Class- How is it possible?
>
> There are different classes in pharmaceuticals.Class ISO 5 is the highest
> cleanliness class, found on pharmaceutical industries and used in LAF and
> sterile filling area.This area is monitored for viable and non-viable
> counts.Some people have confusions about the limits of ISO 5 class and ask
> me for its clarifications.
>
> All cleanliness classes have different standards for viable and non-viable
> particles but ISO 5 has <1 CFU per plate count for the viable count that
> makes the people confused because physically,the existence of less than 1
> CFU is not passable.We cannot count colony forming units less than 1 (in
> decimals) then why all the regulatory guidelines have this specification
> for the ISO 5 class.
>
> Suppose if you had exposed 5 plates and each had 1 CFU then the average
> will be 1 and according to the spacification,the area fails in the viable
> count.
>
> The average of all exposed plates should be less than 1.For example,if you
> have exposed 5 plates and all the plates have the following number of
> colony forming units:
>
> Plate
>
> 1
>
> 2
>
> 3
>
> 4
>
> 5
>
> Count
>
> 1
>
> 0
>
> 1
>
> 1
>
> 0
>
>
>
> Average of these counts is 3/5=0.6 CFU/plate and it is within the
> specification.
>
> You can have more than 1 CFU in one or two plates.See the following
> results:
>
> Plate
>
> 1
>
> 2
>
> 3
>
> 4
>
> 5
>
> Count
>
> 2
>
> 0
>
> 2
>
> 0
>
> 0
>
>
>
> The average of these counts is 4/5=0.8 CFU/plate and it is also complies
> the specification.
>
> Even if you have 4 CFUs in a single plate as below:
>
> Plate
>
> 1
>
> 2
>
> 3
>
> 4
>
> 5
>
> Count
>
> 0
>
> 0
>
> 4
>
> 0
>
> 0
>
>
>
> The average of these counts is 4/5=0.8 CFU/plate and it is also complies
> the specification.
>
> None of the regulatory guidelines says how much count be there in a single
> plate.It means,that you should have 1 CFU less than the number of petri
> plate exposed in a class ISO 5 area to get average CFU les than 1 to comply
> the specification.Therefore, the average of all exposed plates should be
> less than 1CFU/plate but not in any individual plate.
>
> It should be clearly defined in SOPs,how many plates will be exposed in the
> area during viable count monitoring,because the number of plates plays a
> significant role in the determination of average.
>
>
>
> Thank u
>
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>
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>
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>
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>
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>
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>
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>
>
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>


-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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