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ISO 11137 - Verification dose audit for VD max method

M

muzammil21ad

#1
Hi All,

I need one help with respect to verification dose audit for VD max method, we are validating our gamma sterilization process, i face problem with respect to verification dose audit, my gamma subcontractor have dose range starting at 9kGy only but my bio burden is less so the verification dose according to table 9 of 11137 is 7.5kGy,
so please let me know how i should complete my verification dose audit with this type of challenge

:thanx:
 
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Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

This looks like a fairly complex issue, but can someone help with this question?

Thank you very much!
 
B

brianthermophilus

#3
If that's your only dose option and your bioburden is lower, I would run your samples through 9kgy and perform material & packaging assessments to confirm that your product may withstand a higher dose. Nothing wrong with a higher dose as long as your product can handle it.
 
M

muzammil21ad

#4
If that's your only dose option and your bioburden is lower, I would run your samples through 9kgy and perform material & packaging assessments to confirm that your product may withstand a higher dose. Nothing wrong with a higher dose as long as your product can handle it.


Thanks for your comments, this is verification dose to have confidence on my sterility not material compatibility excersise


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pkost

Trusted Information Resource
#5
I would suspect using a higher dose will make the validation ineffective - from recollection the dose is low enough to give a an SAL of 1x10^-2....The subsequent sterilisation tests are sufficiently powered establish the SAL is validated....if you use a higher verification dose then the sterility tests will not be sufficiently powered

I think it is permitted to carry out the VDmax study at any facility, it does not have to be the main site of sterilisation - if you can find somewhere that operates at 7.5kGy, that may be a solution
 
Last edited:
M

muzammil21ad

#6
I think doing dose mapping with 2 different other sources will give you different uncertainty and sterilizing agent characteristics , i am not sure if standard allow me to do ths because i am not as much expert than you may be pls correct me if i am wrong, if it is ok thn my prblm is solved


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pkost

Trusted Information Resource
#7
From my understanding, the dose setting is to demonstrate that the the 25kGy is sufficient to give an SAL of 10-6...25kGy is the same regardless of equipment used; the sterilising agent is gamma radiation...it's consistent

Dose mapping is different as it demonstrates that the entire load receives a dose of 25kGy...I suspect that this may need to be carried out in the intended sterilising facility, but I'm not sure.

The lab that is conducting the validation for you should be able to answer these questions and provide more qualified guidance!
 
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