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November 2018

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No regulatory policy that states these options. But this is standard
practice and you can justify each scientifically. And there is really no
reason to perform method suitability two times (in the lab and in the
isolator). Michael 

From:  The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> on behalf of derek freeman
<[log in to unmask]>
Reply-To:  The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]>
Date:  Monday, November 5, 2018 at 6:00 PM
To:  <[log in to unmask]>
Subject:  Re: [PMFLIST] Sterility Suitability -  Baceriostasis / Fungistasis

Hi All,
I would like to thank everyone for their feedback, it has been most helpful
in fleshing out the available options.

Chris
Partial processing was being considered but there have been some potential
issues raised as to the need to have a comparable / equivalent qualified
pump set up in the lab to that integrated within the sterility test isolator
unit. This was the reason for asking if post media fill - direct spiking of
canisters could be justified. The distance-involved is 200 - 300m, but
avoiding trafficking partially processed canisters around key sensitive site
locations is as much an issue as distance.


Michael,
Yes a specific protocol for VHP ingress into packaging is already in place.
In relation to Stage 2 (Isolator-based) testing, I would usually stick with
the defined test material as it would likely present the  greater recovery
challenge, at the same time I do see that using a less aggressive surrogate
might increase the potential of recovering adventitious contaminants and
providing a greater asepsis challenge, given that Stage 1 has already
established recovery with product. Is there any documented regulatory stance
emerging on this?


By and large, I'm in favor of the two stage approach as advocated by Tony
Cundell & Michael Miller, as it seems a simpler& cleaner approach.

Anyway, thanks again to all

Best Regards

Derek


________________________________
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> on behalf of Knutsen, Chris
<[log in to unmask]>
Sent: 05 November 2018 18:14
To: [log in to unmask]
Subject: Re: [PMFLIST] Sterility Suitability - Baceriostasis / Fungistasis

Derek
What do you mean by some distance?   Could you consider not doing the final
flush and then doing the final flush spiked with the challenge organisms in
the other facility?

Sent from my iPhone

Chris Knutsen
ABO Microbiology

>  On Nov 5, 2018, at 10:56 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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