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Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 13 Jul 2020 23:40:17 +0000
Content-Type:
multipart/related
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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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> >

> >

> >

> > 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

> >

> >

> > =================================

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> > The specific statements and endorsements of individuals

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> >

>

>

> --

> 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

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> Please take a second to visit our sponsors' web sites and say thank

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> 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.

>



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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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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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