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Subject:
From:
Enric Adserà <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 6 Mar 2020 15:03:01 +0100
Content-Type:
text/plain
Parts/Attachments:
text/plain (256 lines)
Hi Alison,

For Bioburden control, the general regulatory limit is: Less than 10
cfu/100 mL of solution.

Sterile compounds fix Alert limits according its historical data for TAMC
and a specific limit for some organisms that have special size or
characteristics that can pass through the filter...

Kind regards,

Enric

*Enric Adserà*
SherpaPharma Project Manager *[log in to unmask]*
<[log in to unmask]>
M. +34 670 418 157 <https://www.linkedin.com/in/enric-adser%C3%A0-0770471/>
T. +34 933 220 636 (Ext. 226)


*sherpapharma.com <http://www.sherpapharma.com/>* Duquessa d'Orleans 46, B-3
08034 *Barcelona* Spain Las Naves, 25 Local 7
28005 *Madrid* Spain




On Fri, 6 Mar 2020 at 14:59, Berman, Alison <[log in to unmask]>
wrote:

> Thanks, Tim.
> The article was interesting, however I am still curious how companies are
> establishing their limits on parenteral in-process bulk samples.
> Alison Berman
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Timothy Cser
> Sent: Thursday, March 5, 2020 11:08 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] In-Process Bioburden Limits
>
> [External Email] - This email is originated from outside of the
> organization. Do not click links or open attachments unless you recognize
> the sender and know the content is safe
>
> Hi Alison.  Search "Microbial Monitoring For Biological Drug Substance
> Manufacturing: An Industry Perspective".  This BPOG working group talks
> about this very topic.
>
> Sincerely,
>
> Tim Cser
> 916-759-1401
> MilliporeSigma
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Berman, Alison
> Sent: Wednesday, March 4, 2020 2:34 PM
> To: [log in to unmask]
> Subject: [PMFLIST] In-Process Bioburden Limits
>
> Hello all,
>
> I am wondering how companies are assigning their alert/action limits for
> pre-filtration bulk bioburden samples if data normally produces zeroes.
> Testing is performed as per USP <61>.
> Is there an approach of considering the limits on the active raw
> materials/volume of WFI used to formulate/validated filter SAL or is it
> simply based on trending alone?
>
> Thanks
>
> Alison Berman, MFS
> Supervisor
> Quality Control - Microbiology
>
> [AMR_Logo_for Email Signatures_19DEC]
>
> O 631.924.4000 ext. 379
> [log in to unmask]<mailto:[log in to unmask]>  \\
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------------------
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Steris - http://www.sterislifesciences.com/

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

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

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

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


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