PMFLIST Archives

August 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:
Bob Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 1 Aug 2020 15:04:23 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (157 lines)
There is an excellent article, "Environmental and Personnel Monitoring
Programs—A Risk-Based Case Study of Cutibacterium acnes", by Ed Tidswell
and Kenneth Boone, published in the recent PDA Journal of Pharmaceutical
Science and Technology:
https://journal.pda.org/content/74/4/408.abstract?etoc

Bob Westney
Director of Quality and Operations
Cryologics, Inc.
www.Cryologics.com

On Thu, Jul 9, 2020 at 7:04 PM Timothy Cser <[log in to unmask]>
wrote:

> Hi Reuben.  I think you probably need to create your internal
> justification.  Was this mandated by a regulator?  If so, you should
> probably ask why.  Was there an organism or set of organisms you can’t
> recover?
>
> Using two temperatures is very common so that’s not an issue. You’d
> probably need to show you can recover something like Cutibacterium acnes
> (previously Propionibacterium acnes) in addition to the 5 classical USP
> organisms.  That’s just one example, you may choose other relevant
> environmental samples but I know C acnes is one of the more difficult to
> recover EM contaminants.
>
> Tim Cser
> MilliporeSigma
> MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany
>
>
> > On Jul 9, 2020, at 6:53 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 -
> https://clicktime.symantec.com/3Erq7pGfrSd3CgY2aJn9CVg6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F
> >
> > Charles River Laboratories -
> https://clicktime.symantec.com/32KCmZKJgTJLjFYf5PanMSG6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
> >
> > Veltek Associates, Inc -
> https://clicktime.symantec.com/367g9KXWC9DQkLTZPztmJwF6H2?u=http%3A%2F%2Fwww.sterile.com
> >
> > Microbiologics, Inc. -
> https://clicktime.symantec.com/3GBTuwd4iNZ4JLW3mY2ULP26H2?u=http%3A%2F%2Fwww.microbiologics.com
> >
> > BD Industrial Media -
> https://clicktime.symantec.com/3USbnYjDuTWPadhNdJMRyrB6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F
> >
> > Associates of Cape Cod, Inc. -
> https://clicktime.symantec.com/3JhnVh7236gYpMitxjts4JH6H2?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.
>
>
> This message and any attachment are confidential and may be privileged or
> otherwise protected from disclosure. If you are not the intended recipient,
> you must not copy this message or attachment or disclose the contents to
> any other person. If you have received this transmission in error, please
> notify the sender immediately and delete the message and any attachment
> from your system. Merck KGaA, Darmstadt, Germany and any of its
> subsidiaries do not accept liability for any omissions or errors in this
> message which may arise as a result of E-Mail-transmission or for damages
> resulting from any unauthorized changes of the content of this message and
> any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its
> subsidiaries do not guarantee that this message is free of viruses and does
> not accept liability for any damages caused by any virus transmitted
> therewith.
>
>
>
> Click http://www.merckgroup.com/disclaimer to access the German, French,
> Spanish and Portuguese versions of this disclaimer.
>
> ------------------
> 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