PMFLIST Archives

September 2012

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Dr.Rajyavardhan Arya" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 18 Sep 2012 22:58:08 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (394 lines)
 Dear all,
              I think there is no requirement of sterility hold time
study. you can perform sterility at any time if fellowed the storge
condition as per product requirement.
                 regards
On 9/15/12, jaideep katarey <[log in to unmask]> wrote:
> Dear All
>
> There are different conditions for sterility testing ,like when u r
> performing the test in-house in the lab so u can proceed the test with
> in 4 hrs. but when send the sample to out-side lab (it's required some
> time for 3rd party products) generally it's take 5-6 days and there is
> no such conditions.
>
> So hold time study shall be perform.
>
>
> Thanks
> Jaideep Katarey
> India.
>
>
> On 9/12/12, Esteban Fuentes <[log in to unmask]> wrote:
>> I agree with the recommendation of processing the sample immediately.
>> Some products are so aggressive with an eventual residual contamination,
>> even without preservatives.  The product storage requirements could be
>> different from the microorganisms survival requirements (into the
>> product).
>> This holding time requires validation.
>>
>> Esteban
>>
>> 2012/9/9 Sanjay Dwivedi <[log in to unmask]>
>>
>>> Dear All,
>>>
>>> Sterility test can be performed any time provided the samples are stored
>>> at proper storage temperature as per product storage requirements
>>>
>>> Regards,
>>> Sanjay Dwivedi
>>> Panacea Biotec Limited
>>> India
>>>
>>>
>>> ________________________________
>>>  From: Bill Gardner Jr <[log in to unmask]>
>>> To: [log in to unmask]
>>> Sent: Friday, 7 September 2012 12:56 AM
>>> Subject: Re: [PMFLIST] Time between sampling and sterility testing
>>>
>>> The sterility test sample hold time should be backed by recovery
>>> studies.
>>>
>>> Bill Gardner
>>> On Sep 5, 2012, at 9:06 AM, Anne Booth wrote:
>>>
>>> > I recommend testing sterility samples as soon as possible after
>>> > exposure
>>> to
>>> > the sterilant. I usually state same day or within 4 hours.  The intent
>>> is to
>>> > capture any live or injured organisms before they have a chance to die
>>> off.
>>> > I don't recommend freezing or waiting days before testing.
>>> >
>>> > Anne F. Booth
>>> > Booth Scientific Inc.
>>> > 120 Kindy Forest Drive
>>> > Hendersonville, NC 28739
>>> > 828-891-7485/cell: 828-216-3157
>>> >
>>> > -----Original Message-----
>>> > From: The Pharmaceutical Microbiology Forum Email List
>>> > [mailto:[log in to unmask]] On Behalf Of Sansoe Emmanuelle
>>> > Sent: Wednesday, September 05, 2012 11:03 AM
>>> > To: [log in to unmask]
>>> > Subject: [PMFLIST] Time between sampling and sterility testing
>>> >
>>> > Dear Forum Members,
>>> >
>>> > Would you know if there are any recommendations for a maximum time
>>> > limit
>>> to
>>> > observe between the time where samples for sterility testing are taken
>>> and
>>> > the time the sterility testing is performed on those samples? Is it
>>> > acceptable to wait 5 days (4 days at 2-8  C and 1 day or overnight at
>>> room
>>> > temperature) before the samples get analysed?
>>> >
>>> > Your inputs will be greatly appreciated.
>>> >
>>> > Many thanks & regards,
>>> >
>>> > Emmanuelle
>>> >
>>> > ------------------
>>> > The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
>>> > The
>>> > Microbiology Network (http://microbiol.org) and supported by our
>>> sponsors
>>> > (http://microbiol.org/sponsor.htm) 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.
>>> >
>>> > Accugenix - http://www.accugenix.com
>>> >
>>> > American Type Culture Collection - http://www.atcc.org
>>> >
>>> > BD Diagnostic Systems - http://www.bd.com/ds/
>>> >
>>> > Biolog - http://www.biolog.com
>>> >
>>> > Biomerieux - http://industry.biomerieux-usa.com
>>> >
>>> > EMD Millipore -  http://bit.ly/Udi4CP
>>> >
>>> > MicroBioLogics, Inc. - http://www.microbiologics.com
>>> >
>>> > Pall - http://www.pall.com
>>> >
>>> > NovaTek International - http://www.ntint.com
>>> >
>>> > Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>>> >
>>> > 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.
>>> > -----
>>> > No virus found in this message.
>>> > Checked by AVG - www.avg.com
>>> > Version: 2012.0.2197 / Virus Database: 2437/5250 - Release Date:
>>> > 09/05/12
>>> >
>>> > ------------------
>>> > The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
>>> > The Microbiology Network (http://microbiol.org) and supported by
>>> > our sponsors (http://microbiol.org/sponsor.htm) 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.
>>> >
>>> > Accugenix - http://www.accugenix.com
>>> >
>>> > American Type Culture Collection - http://www.atcc.org
>>> >
>>> > BD Diagnostic Systems - http://www.bd.com/ds/
>>> >
>>> > Biolog - http://www.biolog.com
>>> >
>>> > Biomerieux - http://industry.biomerieux-usa.com
>>> >
>>> > EMD Millipore -  http://bit.ly/Udi4CP
>>> >
>>> > MicroBioLogics, Inc. - http://www.microbiologics.com
>>> >
>>> > Pall - http://www.pall.com
>>> >
>>> > NovaTek International - http://www.ntint.com
>>> >
>>> > Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>>> >
>>> > 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://microbiol.org/PMFList_info.htm) is operated from
>>> The Microbiology Network (http://microbiol.org) and supported by
>>> our sponsors (http://microbiol.org/sponsor.htm) 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.
>>>
>>> Accugenix - http://www.accugenix.com
>>>
>>> American Type Culture Collection - http://www.atcc.org
>>>
>>> BD Diagnostic Systems - http://www.bd.com/ds/
>>>
>>> Biolog - http://www.biolog.com
>>>
>>> Biomerieux - http://industry.biomerieux-usa.com
>>>
>>> EMD Millipore -  http://bit.ly/Udi4CP
>>>
>>> MicroBioLogics, Inc. - http://www.microbiologics.com
>>>
>>> Pall - http://www.pall.com
>>>
>>> NovaTek International - http://www.ntint.com
>>>
>>> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>>>
>>> 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://microbiol.org/PMFList_info.htm) is operated from
>>> The Microbiology Network (http://microbiol.org) and supported by
>>> our sponsors (http://microbiol.org/sponsor.htm) 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.
>>>
>>> Accugenix - http://www.accugenix.com
>>>
>>> American Type Culture Collection - http://www.atcc.org
>>>
>>> BD Diagnostic Systems - http://www.bd.com/ds/
>>>
>>> Biolog - http://www.biolog.com
>>>
>>> Biomerieux - http://industry.biomerieux-usa.com
>>>
>>> EMD Millipore -  http://bit.ly/Udi4CP
>>>
>>> MicroBioLogics, Inc. - http://www.microbiologics.com
>>>
>>> Pall - http://www.pall.com
>>>
>>> NovaTek International - http://www.ntint.com
>>>
>>> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>>>
>>> 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://microbiol.org/PMFList_info.htm) is operated from
>> The Microbiology Network (http://microbiol.org) and supported by
>> our sponsors (http://microbiol.org/sponsor.htm) 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.
>>
>> Accugenix - http://www.accugenix.com
>>
>> American Type Culture Collection - http://www.atcc.org
>>
>> BD Diagnostic Systems - http://www.bd.com/ds/
>>
>> Biolog - http://www.biolog.com
>>
>> Biomerieux - http://industry.biomerieux-usa.com
>>
>> EMD Millipore -  http://bit.ly/Udi4CP
>>
>> MicroBioLogics, Inc. - http://www.microbiologics.com
>>
>> Pall - http://www.pall.com
>>
>> NovaTek International - http://www.ntint.com
>>
>> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>>
>> 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://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
> our sponsors (http://microbiol.org/sponsor.htm) 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.
>
> Accugenix - http://www.accugenix.com
>
> American Type Culture Collection - http://www.atcc.org
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Biomerieux - http://industry.biomerieux-usa.com
>
> EMD Millipore -  http://bit.ly/Udi4CP
>
> MicroBioLogics, Inc. - http://www.microbiologics.com
>
> Pall - http://www.pall.com
>
> NovaTek International - http://www.ntint.com
>
> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>
> 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.
>


-- 
Dr. Rajyavardhan Arya
Sr. Executive, Quality
Biological E. Ltd.
Dehradun (U.K.)

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

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

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

EMD Millipore -  http://bit.ly/Udi4CP

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

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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.

ATOM RSS1 RSS2