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March 2020

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Subject:
From:
Dina Monsen <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 4 Mar 2020 09:56:49 -0500
Content-Type:
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Thank you for your response Tim.  I have added some clarity...

For full accountability of the media, we collect the media used to prime the
fill needles (to get rid of any air in the lines).  This is not done for
routine manufacturing.  At a previous company, the MHRA gave us an
observation for not collecting this material.  The media was collected into
translucent sample cups.  We were able to see turbidity by day 7.  We
subcultured on Day 7 and returned it to incubation.  Was it necessary to
return it?  Its not going to get more or less positive.

If this fill needle was truly contaminated, I would expect to see at least
every 4th vial as positive (4 filling needles).  We didn't see any during
the day 7 transfer.

The footage showed an issue with the sampling with the likely source of the
contamination (glue from the sampling cup tamper evident sticker).  Do you
think that coupled with this not being a routine production step is
sufficient justification to not repeat (we filled about 5300 vials).

Thank you
Dina


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> On Behalf Of Timothy Cser
Sent: Tuesday, March 3, 2020 5:17 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Positive aseptic simulation sample

Hi Dina.  I think we need some clarification.  If you have a positive purge
sample, how would you know before day 7 or 14? Are  you're testing a purge
sample because you think it was contaminated by the sample cup or it's just
part of your SOP?  Either way, you still have a positive because the process
wasn't aseptic.  That being said, depending on the size of your media fill,
there is some wiggle room where you can investigate 1 positive sample if you
have more than 5000 units.  An investigation is called for and you should
"consider" another media fill.  Above 10,000 units you can have one positive
but will definitely need to investigate, however you don't have to
invalidate the run.  I have customers who don't follow this and will always
redo the media fill if anything is ever positive, regardless of size.

In this case you're suggesting you have video proof of external
contamination so that should help with the root cause.  In my mind, you
should clean and re-run the media fill because the process wasn't aseptic
and that's the point of the entire exercise, even if you don't "technically"
have any positive vials.  Imagine yourself in front of an FDA inspector
trying  to justify your answer to get an idea if you feel comfortable with
your decision.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> On Behalf Of Dina Monsen
Sent: Monday, March 2, 2020 12:57 PM
To: [log in to unmask]
Subject: [PMFLIST] Positive aseptic simulation sample

If you have a positive purge sample during an aseptic simulation, can it be
pulled from incubation on the day of transfer and not incubated the full 14
days?  Also, if the vials are all negative, does the fill needle purge
sample being positive effect the results of the media fill (camera footage
shows that it was likely the sample cup).



Thank you!

Dina

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