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September 2012

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Subject:
From:
"One, Jeff S" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 18 Sep 2012 13:37:11 +0000
Content-Type:
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Dear Ramachandra,

If your eye drops are multi-dose does it contain a preservative?  If yes, you should have anti microbial effectiveness testing studies in addition to sterility testing.  The AET studies (USP <51>)would provide data that bioburden can remain static or below the originally challenged levels over your 28 day period.

Regards,
Jeff One

> Dear Sir,
>
> I need more clarification on the below sentence.
>
> Basically, you do a "simulated" dispensing and check for sterility (TAMC)
> at
> the end.    I would recommend doing intermediate counts on the individual
> samples as well.
>
> As the eye drop formulation is sterile, do I need to check sterility or
> bio-burden at the end and intermittently?
>
>
> Thank you for the guidance document.
>
> Regards,
> Ramchandra
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List
> [mailto:[log in to unmask]] On Behalf Of Scott Sutton
> Sent: Friday, September 14, 2012 11:04 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] In-use stability testing
>
> Ramchandra,
>
> Sure - I did CMC filings for many years in ophthalmics and continue to
> consult in this area - let me take a try at this question.
>
> My personal believes at what are appropriate were published in the article
> In-use Shelf-Life Testing-What Data are Required and When?; with Brian
> Matthews and Danny Dunn. Regulatory Affairs Journal   9:728-733. 1998.
> http://bit.ly/SlcTxc
>
> However, the relevant guidance document is from EMEA Note for Guidance on
> In-Use Stability Testing of Human Medicinal Products - it can be
downloaded
> at
>
>
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
> 09/09/WC500003475.pdf
>
> Basically, you do a "simulated" dispensing and check for sterility (TAMC)
> at
> the end.    I would recommend doing intermediate counts on the individual
> samples as well.
>
> Let me know if you need more info
>
> Scott
> =========
> Scott Sutton, Ph.D.
> Microbiology Network, Inc.
> Consultation and training in contamination control & lab operations
> http://www.microbiol.org
> + 585-594-8273 (office)
> +1 585-298-0767 (global cell)
> [log in to unmask]
> Twitter - @microbiologynet
>
>
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List
> [mailto:[log in to unmask]] On Behalf Of Ramchandra Tallu
> Sent: Friday, September 14, 2012 4:19 AM
> To: [log in to unmask]
> Subject: [PMFLIST] In-use stability testing
> Importance: High
>
> Dear Forum Members,
>
>
>
> We are designing in-use stability study protocol for one of our Eye Drop
> formulation product.
>
>
>
> In this regard I am referring EMEA guide "NOTE FOR GUIDANCE ON IN-USE
> STABILITY TESTING OF HUMAN MEDICINAL PRODUCTS" dated 1 March 2001.
>
> As per this guide, appropriate physical, chemical and microbial properties
> of the product susceptible to change during use should be monitored.
>
>
>
> My question is which test parameters are studied during in-use stability
> testing for microbial properties and at what interval?  The product is
> sterile and to be used within 28days after opening.
>
>
>
> Share your valuable comments.
>
>
>
>
>
> Regards,
>
> Ramchandra
>
>
>
>
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> The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
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> 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.
>
>
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>
> "The Information in this Dossier/email is proprietary, confidential and
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> ------------------
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> 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.


Disclaimer :-

"The Information in this Dossier/email is proprietary, confidential and
  legally privileged. It is intended solely for the Addressee. Access to
  this Dossier/email by anyone else is unauthorized. If you are not the
  intended recipient, any action taken or omitted to be taken in reliance
  on it, in any form of reproduction, dissemination, copying, disclosure,
  modification, distribution and/or publication of this Dossier/Email is
  strictly prohibited. If you receive this Dossier/Email in error, please
  notify us immediately by telephone on 022-30451500/30451200. Please also
  destroy and
  delete the message immediately from your computer".

WARNING: - "Computer viruses may be transmitted via email. The recipient
  should check this email and any attachments for the presence of viruses.
  The company accepts no liability for any damage caused by any virus
  transmitted by this email."
** Message has been scanned by Emergic MailServ **

------------------
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.

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