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November 2019

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Subject:
From:
Bob Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 Nov 2019 16:25:18 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (254 lines)
Scott is correct about in-house isolates...

Per PDA TR 70, “Fundamentals of Cleaning and Disinfection Programs for
Aseptic Manufacturing Facilities”:

“Selection of organisms should be based on the type of environmental
isolates recovered from the facility (environmental isolates are
preferred); however, if facility isolates are not available ATCC cultures …
representing facility isolates are acceptable until facility isolates can
be obtained.”

PDA TR 13, “Fundamentals of an Environmental Monitoring Program”, states:

“It is recommended to periodically review challenge testing of the selected
sanitizers, disinfectants, and sporicides if representative new isolates
are routinely recovered in the environmental monitoring program.  This
supports the effectiveness of the sanitizer, disinfectant, or sporicide on
new contaminants discovered in operations.”

We have myriad regulatory and compendial examples on our website regarding
the requirement to use in-house isolates in D/E testing:
https://cryologics.com/resources/bibliography/.

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

On Thu, Nov 14, 2019 at 8:30 AM Post, Scott <[log in to unmask]> wrote:

> A D/E study using site environmental isolates would be needed.  You may be
> able to leverage the Steris studies to justify not performing a study with
> the ATCC organisms.
>
> Scott
>
> -----Original Message-----
> From: Tony Cundell <[log in to unmask]>
> Sent: Wednesday, November 13, 2019 4:52 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Vesphene/ LpH-more coupon studies?
>
> NOTICE: This message originates from an external source.
> ________________________________
>
> A good question.
>
> A change of the formulation that includes the elimination of an active
> ingredient may require a disinfectant effective study using coupons and a
> follow-up in-situ study.
>
> Have Steris published any studies supporting this formulation change?
>
> The product information states:
>  The LpH III Disinfectants are specifically formulated for
>
> the routine disinfection of hard, non-porous surfaces.
>
> The LpH III Disinfectants are processed and
>
> packaged in a variety of options to meet your specific
>
> application needs. At a use dilution of rate of 0.8%
>
> v/v (1:128), the LpH III Disinfectants kill a broad
>
> spectrum of common bacteria and fungi. The acidic
>
> LpH III Disinfectant formulation can be used alone or
>
> in rotation with the Vesphene® III Disinfectants. These
>
> products have an extensive documentation package
>
> to meet your validation objectives and are supported
>
> by the STERIS Technical Services team for
>
> individualized application and validation assistance.
>
>
> The EPA registration includes the following:
>
>
> Broad spectrum efficacy against
>
> bacteria, fungi, and viruses using
>
> AOAC protocols
>
> On Wed, Nov 13, 2019 at 4:19 PM PICKERING Brian <
> [log in to unmask]>
> wrote:
>
> > Hello All-with Steris discontinuing the current formulations of
> > phenolic disinfectants LpH II and Vesphene II in favor of new
> > formulations Vesphene III and LpH III which do not contain PTAP
> > (p-tert-Amylphenol), do folks see the need to re-execute coupon
> > disinfection efficacy studies or can these new formulations (which are
> > very similar to originals) be qualified in-situ only?
> > Thank you
> >
> > Brian Pickering
> > Associate Director-QC| Microbiology, RM
> > O: (508) 370-5156 | C: (508) 963-3682
> > www.lfb-usa.com<http://www.lfb-usa.com/>
> > [cid:image001.jpg@01D29105.CA5619B0]
> >
> >
> > ------------------
> > The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated
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> > supported by our sponsors as a service to the scientific community.
> >
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> > 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/
> >
> > Steris - http://www.sterislifesciences.com/
> >
> > Charles River Laboratories - http://www.criver.com/
> >
> > Veltek Associates, Inc - http://www.sterile.com
> >
> > Microbiologics, Inc. - http://www.microbiologics.com
> >
> > BD Industrial Media - 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.
> >
>
>
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
> ------------------
> 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/
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - 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/
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - 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/

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

Charles River Laboratories - http://www.criver.com/

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

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

BD Industrial Media - 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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