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May 2020

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 28 May 2020 20:02:07 -0400
Content-Type:
text/plain
Parts/Attachments:
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Dear Zoey,

It depends upon the active ingredient that is present in the product
formulation.  ASTM E2315 is a method for assessing the antimicrobial
activity of a product by using a time-kill method in which you determine
the percent of reduction in a specified time period.  However, ASTM E2315
cannot be used by itself to justify that a product has antimicrobial
activity by the Tentative OTC Drug Monograph for Antimicrobial Topical
Product Formulations.

If your product contains alcohol as the active ingredient (e.g. 60=70%
concentration) and used in a hand rub product formulation, you would use
ASTM E2755 - Standard Test Method for Determining the Bacteria-Eliminating
Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of
Adults

All other actives in hand sanitizers will need to be tested by ASTM
E1174 - Standard
Test Method for Evaluation of the Effectiveness of Health Care Personnel
Handwash Formulations.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

On Thu, May 28, 2020 at 7:20 PM Zhang, Zongyu <[log in to unmask]> wrote:

> For hand sanitizers, do you use the same contact times as what is said at
> ASTM 2315 (15 seconds, 30 seconds and 1min)?
> If we want to evaluate antibacterial lotion or antiseptic lotion, what
> contact time would you suggest? Thanks.
>
> Zoey Zhang
> Senior Scientist, Inolex
> [log in to unmask]
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List On Behalf Of
> Czaplicki, Mary
> Sent: Thursday, April 23, 2020 10:20 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Hand sanitizer testing
>
> Sam,
>
> Hand sanitizers are regulated by the FDA as Over the Counter (OTC) drug
> products. (The EPA regulates surface disinfectants as antimicrobial
> pesticides.)
>
> Hand sanitizers can be evaluated using in vitro methods such as Time Kill
> (ASTM 2315) and in vivo methods including ASTM 2755.
>
> Kind Regards,
>
>
> Mary Czaplicki, M.S.
> Microbiology Scientist II – Research and Development GOJO Industries, Inc.
> [log in to unmask]
>
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Claire Briglia
> Sent: Wednesday, April 22, 2020 2:33 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Hand sanitizer testing
>
> Are you using an EPA registered product?  All antimicrobials with label
> claims legally need to have EPA registration.  EPA provides guidance on the
> required testing.
>
> Bacillus spores thrive in alcohol.
>
>
> Claire Fritz Briglia
> Principal
> Email: [log in to unmask]
> Phone: 814-218-5921
> www.vederesolutions.com
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of sam taba
> Sent: Wednesday, April 22, 2020 11:04 AM
> To: [log in to unmask]
> Subject: [PMFLIST] Hand sanitizer testing
>
> Dear Forum, hope you are all well & safe,
>
> What test would you recommend to evaluate the effectiveness of alcohol
> based hand sanitizer?
> Any references?
>
> Would it be acceptable using strains from USP51 plus Bacillus ATCC6633 to
> determine the effectiveness? using 30 sec and 1 min intervals
>
> thanks for your valued input
>
> Best regards
>
> Sam T
>
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> Veltek Associates, Inc - http://www.sterile.com
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> Microbiologics, Inc. - http://www.microbiologics.com
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> 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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> ------------------
> The PMFList is supported by our sponsors as a service to the scientific
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> Please take a second to visit our sponsors' web sites and say thank you
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> If your company would be interested in sponsoring this community, please
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>
>
> 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
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> Please take a second to visit our sponsors' web sites and say thank you
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>
>
> 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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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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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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