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November 2019

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Subject:
From:
Robert Ryan <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 15 Nov 2019 09:07:59 +0000
Content-Type:
text/plain
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text/plain (119 lines)
In pharma, and for the reasons given this is not expected., validation of your current method would be more valuable.

In medical devices there is a view point that they should be.

You should check which is applicable to you.

Oh and if you get an 80% recovery (well done you), you should divide by 0.8 for your correction factor.

In truth this just adds more variability to your already variable result but make sure you understand what type of material/environment this is applicable to.

Robert Ryan


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Evangelia Georgiadou
Sent: 14 November 2019 14:51
To: [log in to unmask]
Subject: [PMFLIST] Cleaning validation recovery

Dear forum members

After performing a microbiological recovery study for the rinsing and swabbing cleaning validation methods do we have to use the recovery rate result of the study in the routine c.v. calculations?

For example if we have recovery of 80% do we need to multiply the routine results by 0.8?

Thank you all.

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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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