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November 2019

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 13 Nov 2019 16:52:11 -0500
Content-Type:
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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]
>
>
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> 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
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-- 
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.

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