PMFLIST Archives

February 2016

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:
Lucia Ceresa <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 1 Feb 2016 15:23:02 +0100
Content-Type:
text/plain
Parts/Attachments:
text/plain (142 lines)
Hi,

here you are some references:

*Microbial Limits During Operation*

*According to European Union Guidelines (Annex 1)*

*       Air sample               Settle plates           Contanct
plates                  Glove print *

*                                  cfu/cm3                    cfu/4h
                 cfu/plate                          cfu/glove*
* Grade A            < 1                < 1              <
1                       < 1               *





*According to FDA Guidance*

*          ISO               Microbiologycal active air
Microbiological settling plate                            *

*                                                          action level
 cfu/cm3                      action level   cfu/4h
                  *
* Class 100        5                        < 1                         <
1                             *





Dr. Lucia Ceresa

Independent Life Sciences Consultant



2016-01-30 1:37 GMT+01:00 Uday Bhatambarekar <[log in to unmask]>:

> In Sterile Product of WHO expert committee on specification of
> Pharmaceutical Preparation has mentioned for Class 100 specification of
> Cleanliness for Parenteral Preparation is Less than 3 cfu/m3 but in PICs or
> TGA have specified is less than 1 cfu/m3. Actually I want to know why this
> is different. If I found 2 cfu/m3 in Class 100, is it acceptable ? When
> limit is less than 3. If yes, how will the product  be sterile in presence
> of 2 cfu/m3 ?
>
> Uday bhatambarekar
>
> ------------------
> 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.
>
> Accuratus Lab Services http://www.accuratuslabs.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Analytical Research Labs - http://arlok.com/
>
> Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics
>
> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>
> Accugen Laboratories - http://accugenlabs.com
>
> American Type Culture Collection - http://www.atcc.org
>
> ATS Labs - http://www.ats-labs.com
>
> EMD Millipore -  http://www.emdmillipore.com/biomonitoring
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Microtest Laboratories, Inc. - http://www.microtestlabs.com
>
> Steris - http://www.sterislifesciences.com/
>
> Veltek Associates, Inc - http://www.sterile.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.

Accuratus Lab Services http://www.accuratuslabs.com/

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

Accugen Laboratories - http://accugenlabs.com

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

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

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