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November 2018

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Subject:
From:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 5 Nov 2018 11:03:50 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (154 lines)
Derek,

You can separate two needed validations:
1. Method suitability for the product, in which the inoculum would be added
to the final rinse.
2. Demonstration that residual VHP does not interfere with the sterility
testing inside your isolator.
No. 1 can be done outside the isolator.

No. 2 requires you to perform your sterility test in the isolator, using
worse case conditions (maximum exposure to consumables, longest to filter
time, etc.). You can use a surrogate material (e.g., sterile WFI) instead of
product at this point. Then perform growth promotion studies on the final
media to demonstrate organisms will grow under your worse case exposure
conditions.

Separately, you should have done VHP residual studies on your packaging
(e.g., product containers/vials, again, using a surrogate material, and on
consumables) using an analytical method for VHP.

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 11:21 AM
To:  <[log in to unmask]>
Subject:  [PMFLIST] Sterility Suitability -  Baceriostasis / Fungistasis

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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------------------
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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