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November 2018

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Subject:
From:
Vijay Kishore <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 14 Nov 2018 21:42:43 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (184 lines)
Dear Rob,

Since the final stage of DP is solid, same should be considered and for
quantity, total filled i.e active and excipients should be considered.
So by considering solids, if the cake weight is more than 100mg, 10 vials
per membrane and if cake weight is 100 mg or less, 20 vials should be used
for testing.

Thanks,
Vijay Kishore.

On Wed 14 Nov, 2018, 8:42 PM suresh kumar <[log in to unmask]
wrote:

> Dear rob ,
>
> The lyophilized  product come under the category of dry powders , for
> sterility analysis consider  fill volume of vial ( entire quantity ).As per
> the USP the fill volume less than 10g  ,sterility shall be tested for 20
> vials ( 10 vials /media )  and greater than or equal to 10g sterility test
> shall be performed 6 vials ( 3 vials /media ).The product is anitibiotic
> the testing concentration should not exceed 3g /media .
>
> On Wed, Nov 14, 2018 at 2:56 AM Rob E Warburton <
> [log in to unmask]> wrote:
>
> > A colleague recently contacted me about the number of containers to be
> > tested in the sterility test, and we have had a discussion about how to
> > interpret Table 2 in USP <71>. I would greatly appreciate some additional
> > feedback from the PMF list.
> >
> > The material to be sterility tested is a drug product (DP) that is
> > manufactured, filled and lyophilized.  The volume used to reconstitute
> the
> > lyo vial/DP is 5mL and the amount of active in the DP is 10 mg/vial.
> >
> > When using USP <71> Table 2 for determining the quantity to test, the
> > discussion centered around the following:
> >
> >
> > *       Should the liquids part of the table be used taking into account
> > the volume used for reconstitution or should the solids part of the table
> > be used as this is a lyo product.
> >
> > *       If using the solids, is the quantity per container column the
> > total quantity of materials (active + excipients) or is the quantity per
> > container referring to only the quantity of active (drug substance) in
> the
> > vial?
> >
> > The answer to those questions would determine if 10 vials per media is
> > tested or 20 vials per media is tested.
> >
> > Thanks,
> > Rob
> >
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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.
>

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