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July 2020

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Subject:
From:
Girish Raotole <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 14 Jul 2020 21:22:17 +0530
Content-Type:
text/plain
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What is the heading of that guidance ???
Is it journal/annexure/PDF???

On Tue, 14 Jul 2020, 18:53 Timothy Cser, <[log in to unmask]>
wrote:

> Hi Girish.  This is from the FDA Guidance for Industry Aseptic Processing:
>
>
>
> [cid:image001.jpg@01D65934.48953DC0]
>
>
>
> Sincerely,
>
>
>
> Tim Cser
>
> MilliporeSigma
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Girish Raotole
> Sent: Monday, July 13, 2020 9:22 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Media Fill temperature
>
>
>
> Is there any documents refering your suggested practice Tony sir ?????
>
>
>
> On Thu, 9 Jul 2020, 21:10 Tony Cundell, <[log in to unmask]<mailto:
> [log in to unmask]>> wrote:
>
>
>
> > Reuven,
>
> >
>
> > Ironically it is more challenging to justify a change than justifying
>
> > the original procedure.
>
> >
>
> > My first exposure to media fills was with large volume parenterals and
>
> > we incubated the media fill at controlled room temperature for 14 days
>
> > in product storage and inspection area as we had no walk-in
>
> > incubators, The incubation conditions were justified by industry
>
> > practice and growth promotion testing.
>
> >
>
> > The regs suggest any temperature between 20- 35 degree C that is
> justified.
>
> > My opinion incubation at 28 degree C for 14 days may be optimal.
>
> >
>
> > Tony
>
> >
>
> > On Thu, Jul 9, 2020 at 9:51 AM Reuven Baum <[log in to unmask]<mailto:
> [log in to unmask]>> wrote:
>
> >
>
> > > We previously incubated media fills at 20-25C for 14 days.
>
> > > We intend to change to 20-25C for 7 days followed by 30-35C for 7 days.
>
> > >
>
> > > What level of justification is needed for this change ?
>
> > > Is a risk assessment enough ?
>
> > > Do we need to do a study with microorganisms  ?
>
> > >
>
> > >
>
> > > Reuven
>
> > > QC Microbiologist
>
> > > Isotopia
>
> > >
>
> > > ------------------
>
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> > > please contact [log in to unmask]<mailto:
> [log in to unmask]>.
>
> > >
>
> > >
>
> > >
>
> > > Steris -
>
> > > https://clicktime.symantec.com/35ZvvQDekhrid9XRmUKo7Hr6H2?u=http%3A%<
> https://clicktime.symantec.com/35ZvvQDekhrid9XRmUKo7Hr6H2?u=http%3A%25>
>
> > > 2F%2Fwww.sterislifesciences.com%2F
>
> > >
>
> > > Charles River Laboratories -
>
> > > https://clicktime.symantec.com/3Rk4PwqcARcshCHhQiDKTPy6H2?u=https%3A
>
> > > %2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
>
> > >
>
> > > Veltek Associates, Inc -
>
> > > https://clicktime.symantec.com/3QYiHUC8EfDfoWyrZUrAAWS6H2?u=http%3A%<
> https://clicktime.symantec.com/3QYiHUC8EfDfoWyrZUrAAWS6H2?u=http%3A%25>
>
> > > 2F%2Fwww.sterile.com
>
> > >
>
> > > Microbiologics, Inc. -
>
> > > https://clicktime.symantec.com/3GEZ7NXWZgoGWFSBFBY4yWm6H2?u=http%3A%<
> https://clicktime.symantec.com/3GEZ7NXWZgoGWFSBFBY4yWm6H2?u=http%3A%25>
>
> > > 2F%2Fwww.microbiologics.com
>
> > >
>
> > > BD Industrial Media -
>
> > > https://clicktime.symantec.com/3G3dm3RrPXaAGGHn1QQqXHR6H2?u=http%3A%<
> https://clicktime.symantec.com/3G3dm3RrPXaAGGHn1QQqXHR6H2?u=http%3A%25>
>
> > > 2F%2Fwww.bd.com%2Fds%2F
>
> > >
>
> > > Associates of Cape Cod, Inc. -
>
> > > https://clicktime.symantec.com/3GAgzicLDn1H5poEFjzocsb6H2?u=http%3A%<
> https://clicktime.symantec.com/3GAgzicLDn1H5poEFjzocsb6H2?u=http%3A%25>
>
> > > 2F%2Fwww.acciusa.com%2F
>
> > >
>
> > >
>
> > > =================================
>
> > > 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
>
> > > PMF or the sponsors of the list.
>
> > >
>
> >
>
> >
>
> > --
>
> > Tony Cundell, Ph. D.
>
> > Consulting Microbiologist
>
> > Email: [log in to unmask]<mailto:[log in to unmask]>
>
> > Phone: 914 725-3947
>
> > Cell: 914 841-0074
>
> >
>
> > ------------------
>
> > The PMFList is 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]<mailto:
> [log in to unmask]>.
>
> >
>
> >
>
> >
>
> > Steris -
>
> > https://clicktime.symantec.com/35ZvvQDekhrid9XRmUKo7Hr6H2?u=http%3A%2F
>
> > %2Fwww.sterislifesciences.com%2F
>
> >
>
> > Charles River Laboratories -
>
> > https://clicktime.symantec.com/3Rk4PwqcARcshCHhQiDKTPy6H2?u=https%3A%2<
> https://clicktime.symantec.com/3Rk4PwqcARcshCHhQiDKTPy6H2?u=https%3A%252>
>
> > F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
>
> >
>
> > Veltek Associates, Inc -
>
> > https://clicktime.symantec.com/3QYiHUC8EfDfoWyrZUrAAWS6H2?u=http%3A%2F
>
> > %2Fwww.sterile.com
>
> >
>
> > Microbiologics, Inc. -
>
> > https://clicktime.symantec.com/3GEZ7NXWZgoGWFSBFBY4yWm6H2?u=http%3A%2F
>
> > %2Fwww.microbiologics.com
>
> >
>
> > BD Industrial Media -
>
> > https://clicktime.symantec.com/3G3dm3RrPXaAGGHn1QQqXHR6H2?u=http%3A%2F
>
> > %2Fwww.bd.com%2Fds%2F
>
> >
>
> > Associates of Cape Cod, Inc. -
>
> > https://clicktime.symantec.com/3GAgzicLDn1H5poEFjzocsb6H2?u=http%3A%2F
>
> > %2Fwww.acciusa.com%2F
>
> >
>
> >
>
> > =================================
>
> > 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 PMF or the
>
> > sponsors of the list.
>
> >
>
>
>
> ------------------
>
> The PMFList is 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]<mailto:
> [log in to unmask]>.
>
>
>
>
>
>
>
> Steris -
> https://clicktime.symantec.com/35ZvvQDekhrid9XRmUKo7Hr6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F
>
>
>
> Charles River Laboratories -
> https://clicktime.symantec.com/3Rk4PwqcARcshCHhQiDKTPy6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
>
>
>
> Veltek Associates, Inc -
> https://clicktime.symantec.com/3QYiHUC8EfDfoWyrZUrAAWS6H2?u=http%3A%2F%2Fwww.sterile.com
>
>
>
> Microbiologics, Inc. -
> https://clicktime.symantec.com/3GEZ7NXWZgoGWFSBFBY4yWm6H2?u=http%3A%2F%2Fwww.microbiologics.com
>
>
>
> BD Industrial Media -
> https://clicktime.symantec.com/3G3dm3RrPXaAGGHn1QQqXHR6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F
>
>
>
> Associates of Cape Cod, Inc. -
> https://clicktime.symantec.com/3GAgzicLDn1H5poEFjzocsb6H2?u=http%3A%2F%2Fwww.acciusa.com%2F
>
>
>
>
>
> =================================
>
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> discussions are not necessarily those of the PMF or the sponsors of the
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> ------------------
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> Please take a second to visit our sponsors' web sites and say thank you
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> If your company would be interested in sponsoring this community, please
> contact [log in to unmask]
>
>
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> 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 PMF or the sponsors of the
> list.
>

------------------
The PMFList is 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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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 PMF or the sponsors of the list.

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