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September 2012

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Fri, 14 Sep 2012 17:42:12 +0000
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Hello Ramchandra,

There are several different microbial tests that might be performed depending on the product type.  A few of the more common tests are sterility testing to assure that sterility was maintained during the aging process, preservative testing if your product contains a preservative,  package integrity tests (both physical and microbial), toxicity test as percentages in key components may shift, and other tests as assessed by your product needs.  

Regards,



Tonya M. Morris, B.S. SM(NRCM), ASQ CQA
Pharmaceutical Section Leader


p: 801 290 7849
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www.nelsonlabs.com
6280 South Redwood Rd. SLC, UT 84123
At Nelson Laboratories, we believe in The Science of Success(tm)




-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Ramchandra Tallu
Sent: Friday, September 14, 2012 2:19 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
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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