PMFLIST Archives

September 2019

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Kumar Das <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 6 Sep 2019 09:24:13 +0600
Content-Type:
text/plain
Parts/Attachments:
text/plain (350 lines)
Dear Members,
In reference to discussion in cfu counting in ISO Class 100 area,
If the recommended limit is <1cfu, then what would be the alert/action
limits as it is semiquantitative method.
Is it required to set alert/action limit for this area?
Or what would be the set limits in taking action for contamination control?

Bichitra Kumar
Sr. QCO.
Sterile Unit.
Bangladesh.

On Thu, Sep 5, 2019, 10:31 PM Joel Russo <[log in to unmask]> wrote:

> Ashwini,
>
> Read the US v Barr case (90’s or so?) and the conclusion that was reached
> about averaging yourself into specification.  Then revisit your Quality
> approach.
>
> Best,
> Joel
>
> > On Sep 4, 2019, at 10:57 PM, Kulkarni, Ashwini <
> [log in to unmask]> wrote:
> >
> > Hi,
> >
> > This logic is applicable for all the classes/grades not only to grade A
> then.
> >
> > Consider the scenario:
> >
> > If you are exposing 5 plates in grade D area and for settle plate counts
> are:
> >
> > Plate 1: 60 cfu/plate/4 hour
> > Plate 2: 40 cfu/plate/4 hour
> > Plate 3: 22 cfu/plate/4 hour
> > Plate 4: 06 cfu/plate/4 hour
> > Plate 5: 03 cfu/plate/4 hour
> >
> > Considering average its 26.2 cfu/4 hour, Conclusion: Grade D area is
> passing its alert limit/acceptance criteria of 50 cfu/4 hour even if one
> location exceeds count (see plate no.1).
> > If above scenario is correct still, I think it should trigger
> investigation and conclusion of investigation should include all these
> considerations.
> >
> > Regards.
> > Ashwini Kulkarni
> >
> > -----Original Message-----
> > From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Evangelia Georgiadou
> > Sent: Monday, September 02, 2019 1:25 PM
> > To: [log in to unmask]
> > Subject: [PMFLIST] Cfu counts in class A
> >
> > 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
> >
> > ------------------
> > 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.
> > Notice & Disclaimer - This email and any files transmitted with it
> contain Proprietary, privileged and confidential information and/or
> information protected by intellectual property rights and is only for the
> use of the intended recipient of this message. If you are not the intended
> recipient, please delete or destroy this and all copies of this message
> along with the attachments immediately. You are hereby notified and
> directed that (1) if you are not the named and intended addressee you shall
> not disseminate, distribute or copy this e-mail, and (2) any offer for
> product/service shall be subject to a final evaluation of relevant patent
> status. Company cannot guarantee that e-mail communications are secure or
> error-free, as information could be intercepted, corrupted, amended, lost,
> destroyed, arrive late or incomplete, or may contain viruses. Company does
> not accept responsibility for any loss or damage arising from the use of
> this email or attachments.
> >
> > ------------------
> > 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.
>
> ------------------
> 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.
>

------------------
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.

ATOM RSS1 RSS2