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Sterilisation Validation - VDmax for e-beam

J

jampot

#1
Hello
We are considering using e-beam to terminally sterilise a medical device and I wondered if the VDmax method (previously applied to substantiate 25kGy gamma for a different device) can be used to validate this particular sterilisation process?

Any other guidance on the use of e-beam would be appreciated

Thanks in advance
Jampot
 
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Al Rosen

Staff member
Super Moderator
#2
This is not an area that I'm an expert in, but I would think you would have to validate the sterilization process of each device unless they are similar enough to be considered a family. Hopefully someone with the experience in this will comment.
 
M

Microbe

#3
Like Al, I'm not an expert on e-beam, but if you look at ISO11137-2:2006 - Sterilisation of health care products - radiation - part 2 establishing the sterilisation dose it does quote the VDmax method.

Regards

Microbe
 
K

Kees Fremery

#4
When you look at the scope if the ISO 11137-1 you can see that it covers Gamma radiation and also e-beam.
Using e-beam you do have to consider the transference of radiation sources. This is depending on your product. See 8.4 of ISO11137-1
If you want to make use of the data of the first validation you can find guidance in part 2, chapter 4.4

I hope this helps you.

With kind regards,
Kees Fremery
 
V

vinodashri

#5
Hello

I have a question. We have validated our product using e beam sterilization. Now we want to consider Gamma sterilization and validate our product. Once we finish validating, Can we alternate between e beam and gamma sterilization for the same product? Since we have validated in both methods, can we use both methods alternately for sterilizing our products.

Please let me know.

Thanks
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi,

I believe the best way to handle (and control) it would be as 2 different products, that you could then sell as equivalents to clients who were made aware.

Cheers,
Ronen.
 
K

Kees Fremery

#7
If you have validated both e-beam and gamma you can switch for sterilization between the two techniques. The condition however is that you perform Dose Audits on both gamma and beam. I think this only applies to the verification experiment and the Bioburden is covering both.
 
C

csterling

#8
Hello

I would like feedback on the following scenario:

For e-beam sterilization, it is acceptable to do a verification dose with sterilization provider -X- and then, the dose mapping with another sterilization provider -Y- with the intention to use sterilization provider -Y- for routine sterilization processing.

:thanx:
 
V

vinodashri

#9
Thank you all. Do we have to repeat shelf life testing when we shift from e-beam to gamma sterilization methods? Or can we use the same accelerated aging and shelf life results for gamma as well. Only the sterilization method is changing, the product and the packaging remains the same. Please let me know.
 
C

csterling

#10
Hello All

I have another question:

We are using e-beam sterilization. The product was validated using VDmax 25.
Let say that the average bioburden of the product when validated was 3.5cfu and then after a couple of dose audits the average bioburden is 10.5cfu....

Could we say that no actions are needed because according to the standard for an average bioburden of 3.5 using 25kGys the bioburden could go up to 220cfus?

Thanks in advanced.
 
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