PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Girish Raotole <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 13 Jul 2020 21:51:52 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (130 lines)
Is there any documents refering your suggested practice Tony sir ?????

On Thu, 9 Jul 2020, 21:10 Tony Cundell, <[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]> 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
> >
> > ------------------
> > 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.
> >
>
>
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [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]
>
>
>
> 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.

ATOM RSS1 RSS2