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Subject:
From:
Frank Settineri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 6 Mar 2020 18:43:20 +0000
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A work around the 10 CFU/100 mL "prefiltration" bioburden is to insert a 0.45 um filter AFTER the compounding tank and take the bioburden sample after the filter.  If starting with a relatively clean process a bioburden of 10 CFU/100 mL can be readily achieved.  
Downstream, two, 0.22 um filters would need to be used as sterilizing filters. To summarize three filters are required: a 0.45 um filter (for bioburden reduction) and duplicate 0.22 um filters for sterilization.
I've personally used this setup and recommended it to clients; US, European and ROW agencies have accepted it. 
Sincerely,

Frank Settineri 
Veracorp LLC 
Sparta, New Jersey 
908-499-5540 
www.veracorp.biz 
http://www.linkedin.com/in/veracorp

Strengthening Businesses, Strengthening Lives
 

    On Friday, March 6, 2020, 01:21:20 PM EST, Tony Cundell <[log in to unmask]> wrote:  
 
 Chris has supplied a useful EMA guidance document.

A distinction must be made between bioburden control during downstream
processing and bulk solution prior to sterile filtration.

The EMA NMT 10 cfu/100 mL limit is extremely conservative as a challenge to
a sterilizing filter or control a bioburden that may add bacterial
endotoxins to the product. Also it the limit for WFI.

A sterilizing filter validation requirement is > 10^7 CFU per sq. cm of
filter area. Given the surface area of cartridge filter and the volume of
the bulk product and bioburden would easily be 2-3 magnitudes higher, i.e.
10 or 100 cfu/mL.

In terms of downstream processing, most companies have a
bioburden-reduction filtration after each major processing step and may
maintain the product at 2-8 degree C to limit bacterial growth.

On Fri, Mar 6, 2020 at 11:22 AM Knutsen, Chris <
[log in to unmask]> wrote:

> For the pre-sterile filtration bioburden specification, see the EMEA "Note
> for Guidance on Manufacture of the Finished Dosage Form" on page 5/6.  It
> states that, for most situations, NMT 10 CFU/100 mL is acceptable.  You
> should get a copy of this guidance for your records.
>
>
> Chris Knutsen, PhD
> Technical Fellow| Microbiology Center of Excellence
> Analytical Strategy and Operations
>
> Office +1 732-227-5375
> Mobile +7 609-751-8362
>
> Bristol Myers Squibb
> 1 Squibb Drive
> New Brunswick, NJ 08903
>
> bms.com / LinkedIn / Twitter / Facebook / Instagram
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Berman, Alison
> Sent: Wednesday, March 4, 2020 5:34 PM
> To: [log in to unmask]
> Subject: [PMFLIST] In-Process Bioburden Limits
>
> [Use CAUTION when opening links/attachments]
>
> 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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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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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]



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/

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]



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/

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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