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November 2018

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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 5 Nov 2018 11:22:22 -0500
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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From:
Tony Cundell <[log in to unmask]>
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Derek,

The intent is that inoculation must occur as part of the final rinse prior
to media fill to ensure that all potential  inoculum  / membrane / product
residue interactions are captured.

You can conduct the suitability testing in the microbiology lab not the
sterility suite as with an enclosed membrane filtration canister these is a
low change of media contamination. You can confirm the growth in the media
is due to the suitability test organisms.

Tony

On Mon, Nov 5, 2018 at 10:51 AM derek freeman <[log in to unmask]>
wrote:

> Just a quick question to canvass  opinion;
>
> Currently have a requirement to  conduct suitability testing for
> sterility  (membrane filtration),  but the Sterility Test Suite is located
> some distance from the lab facility.  To remediate, logistics /
> bio-contamination risk issues,  the plan is to conduct  the  "final spiking
> step"  of the canisters with low level inoculum of the appropriate  type
> cultures, within the laboratory.
>
> All prior handling steps, decontamination, reconstitution, filtration and
> initial rinses  will take place within the qualified Sterility Test
> Isolator to capture variation during decontamination and handling.
>
> The issue relates to the final inoculation step. Keeping in mind that the
> harmonised method  for MF refers to
> adding  "an inoculum of a small number of viable microorganisms (not more
> than 100 cfu) to the final portion of the sterile diluent used to rinse the
> filter".
>
> 1)  whether it would be permissible to add the inoculum directly to the
> media filled canisters (under controlled conditions) or is it the intent
> that inoculation must occur as part of the final rinse prior to media fill
> to ensure that all potential  inoculum  / membrane / product residue
> interactions are captured?
>
> 2)  if the intent is such would it be acceptable to firstly conduct a full
> Suitability Testing  program under controlled lab conditions (i.e. but not
> employing the actual Sterility Test Isolator or associated equipment) in
> order to demonstrate recovery (absence of bacteriostasis / fungistasis)
> and then run a second series using  the defined equipment (the Sterility
> Test Isolator) but with the amendment of a final (lab-based)  direct
> inoculum of the prior processed and  media filled canisters?
>
> Thanking you in advance for your feedback,
>
> Best Regards
> Derek
>
>
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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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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/

Sartorius https://promotions.sartorius.com/real-heroes

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

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

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

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

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

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

BD Diagnostic Systems - 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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