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.
------------------
The PMFList (https://clicktime.symantec.com/3MN3MSbWHb5DtsrGdL2kpis6H2?u=http%3A%2F%2Fmicrobiologynetwork.com%2Fpmflist.asp) is operated from The Microbiology Network (https://clicktime.symantec.com/3XUpmHUwNeN9DZkGzVDexJZ6H2?u=http%3A%2F%2Fmicrobiologynetwork.com) 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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]
Science Advisory Board https://clicktime.symantec.com/35uKScbfKu1u7q5YwtaoTXf6H2?u=https%3A%2F%2Fwww.scienceboard.net%2F
Steris - https://clicktime.symantec.com/3LZbtYxay25p1gQEUcFaPWB6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F
Charles River Laboratories - https://clicktime.symantec.com/39WJ5KCc28qMRveCy4hTK8T6H2?u=http%3A%2F%2Fwww.criver.com%2F
Veltek Associates, Inc - https://clicktime.symantec.com/3TLoMFYeoM8mmwGQpzbbc6D6H2?u=http%3A%2F%2Fwww.sterile.com
Microbiologics, Inc. - https://clicktime.symantec.com/39EYaTXwLY34enTK1hLxZkQ6H2?u=http%3A%2F%2Fwww.microbiologics.com
BD Industrial Media - https://clicktime.symantec.com/3Mpk6swKToCA8hEqgEUR8uY6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F
Boston Analytical https://clicktime.symantec.com/3PwEpx8Fs1rhvjSFXeS6uEE6H2?u=http%3A%2F%2Fwww.bostonanalytical.com%2F
Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3JwfqcFrk5FTHKVEusRJHUH6H2?u=http%3A%2F%2Fwww.acciusa.com%2F
=================================
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.
External Email
Disclaimer:
This e-mail and any files transmitted with it are confidential
and intended solely for the use of the individual or entity to
whom they are addressed. If you should not have received this
email, please delete it without printing and let us know. We do
not accept any liability for any errors or omissions which
occur as a result of transmission nor for any virus or other
harmful code which may be attached or embedded.
This email was sent from Thornton & Ross Ltd. Telephone
01484 842217, Fax 01484 847301
Thornton & Ross Ltd Registered Office:
Linthwaite, Huddersfield, HD7 5QH
Registered in England No: 185947
http://www.thorntonandross.co.uk
______________________________________________________________________
This email has been scanned by the Symantec Email Security.cloud service.
For more information please visit http://www.symanteccloud.com
______________________________________________________________________
------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) 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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]
Science Advisory Board https://www.scienceboard.net/
Steris - http://www.sterislifesciences.com/
Charles River Laboratories - http://www.criver.com/
Veltek Associates, Inc - http://www.sterile.com
Microbiologics, Inc. - http://www.microbiologics.com
BD Industrial Media - http://www.bd.com/ds/
Boston Analytical http://www.bostonanalytical.com/
Associates of Cape Cod, Inc. - http://www.acciusa.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.
|