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February 2016

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Subject:
From:
Nilesh Shah <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 23 Feb 2016 10:24:34 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (224 lines)
Dear Forum Members,
Thanks Tim Sir.
Please clarify.
1. What will be sample volume to be sucked for Grade A area.
    As per calculation 689.65 liter per location. As per Tim Sir
presentation Volume for grade B area is 6.9 litres= 7
    litres per location.

2. Also Minimum sampling volume is 1000 litres then is it necessary to
convert sample (counts per 28.3 litres) to
    counts per cubic meter?

Thanks,

Nilesh

9820919185






On Mon, Feb 22, 2016 at 6:36 PM, Ely, Gordon <[log in to unmask]>
wrote:

> The Institute of Environmental Sciences and Technology (IEST) is the
> Secretariat for ISO/TC209. They offer technical sessions and tutorials to
> help people navigate the changes in these two revised standards (published
> Dec. 15, 2015). IEST was actually offering these classes and sessions for
> the last couple years to help those using cleanrooms to prepare for the
> changes. For more information, please see the website (www.iest.org) or
> feel free to contact me. I am the Technical VP of the Contamination Control
> Division of IEST.
>
> Gordon M. Ely, RM/SM (NRCM), ASQ CQA
> Senior Technical Specialist
> WuXi AppTec
> 1265 Kennestone Circle
> Marietta, GA 30066
> 1-770-514-0262
> 1-888-847-6633, ext. 3272
> [log in to unmask]
> US.wuxiapptec.com
> www.wuxiapptec.com
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Tim Sandle
> Sent: Sunday, February 21, 2016 6:04 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Cleanroon Standards - ISO 14644-1 and 2
>
> Hello,
> I recently presented a webinar on the revised standard. I have put the
> slides on-line, which may be of interest. They can be found here:
> https://www.researchgate.net/publication/292984427_ISO_14644_-_Revised_Cleanroom_Standard
> Tim Sandle
>
>     On Sunday, 21 February 2016, 22:14, Bittu Dave <[log in to unmask]>
> wrote:
>
>
>   Dear all, I came across  the site (
> http://www.iso.org/iso/catalogue_detail?csnumber=53394) that indicates
> that  the International Cleanroom Standards (ISO 14644-1 & 2) have been
> updated, these changes affect the requirements for the classification
> testing and monitoring of ALL cleanrooms. The classification testing
> standard has significant changes and includes the requirements for the
> development of a “Monitoring Plan” based upon risk assessment.
> A risk based approach to environmental monitoring is emphasized in the new
> ISO standard and the current EU Annex 1.  I am looking for the further
> information with regards to this and the risk based approach  for
> environmental  monitoring and limits apply now. If someone has this
> information to share , that would be greatly appreciated.
>
> Best wishesBittu.
>
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> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
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> Please take a second to visit our sponsors' web sites and say thank you
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> Accuratus Lab Services http://www.accuratuslabs.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Analytical Research Labs - http://arlok.com/
>
> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Steris - http://www.sterislifesciences.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
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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 PMF, or the sponsors of the list.
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> 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.
>
> Accuratus Lab Services http://www.accuratuslabs.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Analytical Research Labs - http://arlok.com/
>
> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Steris - http://www.sterislifesciences.com/
>
> Veltek Associates, Inc - http://www.sterile.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.

Accuratus Lab Services http://www.accuratuslabs.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

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

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

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