To the best of my knowledge it require to study sample hold time
validation.This is to be performed by spiking sample with 100 cfu reference
cultures and EM and water isolates.Thereafter recovery of organisums is to
be find out.Acceptece criteria as per pharmacoepia.
Sample is to be kept at 2 - 8 degree temp. and hold time study is to
performed.
Regards,
Priyal pradeep Tarwadi
On Wed, May 13, 2015 at 12:19 PM, e-mail brianmatthews <
[log in to unmask]> wrote:
> I would have thought that​ there is also a risk that microorganisms could
> multiply in some products if the testing is delayed too long (unless
> refrigerated storage is used - and has been validated as not affecting
> organism viability).
>
> Regards,
>
> Brian Matthews.
>
>
> On 6 May 2015 at 04:25, Girdhari Lal Yadav <[log in to unmask]> wrote:
>
> > Dear Cristian Gonzalez
> >
> > As per my experience, you can keep bioburden samples in refrigerator
> (i.e.
> > 2-8 degree celsius) upto 5 hours. I will revert back to you with
> reference
> > detail for the same
> >
> >
> > Regards
> > Girdhari
> >
> >
> >
> > -----Original Message-----
> > From: Pharmaceutical Stability Discussion Group [mailto:
> > [log in to unmask]] On Behalf Of Crystal Booth
> > Sent: Wednesday, April 29, 2015 9:55 PM
> > To: [log in to unmask]
> > Subject: Re: [PSDGLIST] Bioburden Holding Time
> >
> > Hi Cristian,
> >
> > This is a current regulatory hot topic. You are expected to understand
> > your product and if your method can recover microorganisms accurately if
> > they are present. If you let the sample sit too long, there is a
> potential
> > for microorganisms to die off or adhere to the sampling container and go
> > undetected.
> >
> > Kind regards,
> > Crystal Booth, M.M
> >
> > > On Apr 23, 2015, at 4:39 PM, Gonzalez, Cristian-1 (Ext) <
> > [log in to unmask]> wrote:
> > >
> > > Hi,
> > > I just want to know if there are any guide or regulation related to
> > Bioburden Holding time. In a previous experience we received a bioburden
> > samples and never had a due date to put the test (holding time).
> > >
> > > Appreciate your help!!
> > >
> > > Cristian Gonzalez
> > > Microbiology
> > > [log in to unmask]<mailto:
> [log in to unmask]
> > >
> > > Tel. 919-577-5372
> > >
> > >
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> The nature of this service is to provide a medium for communication. The
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> Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
> and
> Ultra Low Storage Chambers with Complete Validation, Maintenance &
> Calibration
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
> http://www.StabilityEnvironments.com
> High quality controlled environmental walk-in rooms and reach-in
> chambers
> Full installation, validation and spare parts also available
>
> Hardy Diagnostics - http://www.HardyDiagnostics.com
> Provides a complete selection of laboratory and microbiology supplies
> for the clinical, industrial, and molecular biology research
> communities.
>
=================================
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
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Hardy Diagnostics - http://www.HardyDiagnostics.com
Provides a complete selection of laboratory and microbiology supplies
for the clinical, industrial, and molecular biology research communities.
|
