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October 2019

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Subject:
From:
"Langley, Shannon" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 25 Oct 2019 18:12:43 +0000
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Gabrielle,
I would not add more interim reads that necessary.  More handling of media fill units by personnel just increases the opportunity for something to go wrong in the sample handling process that may increase the chance for a positive unit.  Seems it adds more risk and you could end up spending your time investigating a positive that was not really related to your aseptic processing but would be difficult to prove with data.  At most, perhaps a risk evaluation that justifies your current read program that includes your sites typical flora and their growth pattern/robustness.

Thanks,
Shannon Langley
Sr. Laboratory Manager
Aseptic Processing 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Gabrielle Melancon
Sent: Thursday, October 24, 2019 1:26 PM
To: [log in to unmask]
Subject: [PMFLIST] Sterility Reads for Media Fills

Good Morning, 

 
Does anyone have experience with performing sterility readsfor media fills/aseptic process simulations outside of a 7 day interim read and a 14 day final read? What is you reasoning/justification for needing to do theseadditional reads? 

 I received a recommendation this week to perform morefrequent interim reads of media fill vials with the justification being thatthere could be growth observed in the vial and the organism could then die-off and be re-absorbed intothe TSB resulting in a negative growth observation during the 7 or 14 day read.

 I will admit, I have not heard of a situation where a turbid vialwill turn clear even if the nutrients have been used up and the organism hasdied in the vial. 

Additional input is greatly appreciated, Gabrielle

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