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March 2016

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Subject:
From:
pradeep tarwadi <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Sun, 6 Mar 2016 21:33:22 +0530
Content-Type:
text/plain
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text/plain (117 lines)
Hi Muma,

USP <1116> clearly stated that < 5 per garment means it is to be consider
whole Garment bio load therefore sum of cfu from different sampling
location is to be considered.
I agree with example given by Isaac.

From,
Pradeep Tarwadi,Ahmedabad

On Fri, Mar 4, 2016 at 9:40 AM, isaac addala <[log in to unmask]> wrote:

> Hi Muma
>
> Our practice is individual location less than 3cfu, all locations should
> not exceed 5cfu. Less than 0 cfu  per Gloved finger dabs on 90mm
> neutralizer add plate l.
>
> Example
> If a personal monitoring sample recover’s one cfu in all location six
> location then the result is failed.
> If the recovery is one c f u on gown at three different locations or one
> location he passes the limit.
> Finger dabs less than zero cfu
>
> This our practice please correct me if I am wrong.
> Isaac
>
> Sent from Outlook Mail<https://go.microsoft.com/fwlink/?LinkId=550987>
> for Windows 10 phone
>
> From: MUMA M<mailto:[log in to unmask]>
> Sent: 03 March 2016 22:20
> To: [log in to unmask]<mailto:
> [log in to unmask]>
> Subject: [PSDGLIST] Reg personnel monitoring
>
> Hello all,
>
> As Per USP chapter 1116, the personnel sampling limit of gown/garment is 5
> cfu/garment.
>
> If i have 6 different sampling locations on the garment..if i get 1 colony
> per plate i.e., 6 colonies for 6 plates..i.e, 6 colonies per garment..
>
> My question is whether we have to count individual colonies per plate
> (complies) or count the total garment counts 5 cfu/garment (does not
> comply)..
>
> Thanks
> MUMA
>
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> 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 PSDG, or the sponsors of the list.
>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
> Microbiology Network (http://www.microbiol.org) 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.
>
> BahnsonEnvironmental Specialties - http://www.eschambers.com/
>    Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
> and
>    Ultra Low Storage Chambers with Complete Validation, Maintenance &
> Calibration
>
> Cincinnati Sub-Zero - http://www.cszindustrial.com/
>    Provides a large selection of environmental chambers from benchtop,
> reach in to walk-in
>     rooms along with chambers for freeze/thaw, temperature cycling
> applications.
>

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
   Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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