Gamma Irradiation - Multiple doses to achieve the Dose range

[Balachander]

Hi,

We have some of our products sterilized by Gamma and its been validated using VDmax22.5 with 3.1 aug dose setting at the moment with Min dose = 25.6 Kgy and Max dose= 50Kgy. The sterilizer provider wants to update the spec due to costing issues now. He is suggesting from now on that they will irradiate our products in their regular medical category with at least 25 kGy as ref point (usually it is above) and in case of need they will "top-up" the dose with another irradiation in our 5-15 kGy category. Meaning if they dont achieve the min dose, they will provide another dose.

I just want to know if this is acceptable without doing any re-validation.?

will there any issues with the products in case of 2 doses (multiple doses to achieve the dose range?

He is suggesting to change the product spec and having a rationale as to why this is acceptable. He confirmed that we will achieve the min dose this way and the sterilization certificate will include all details.

Let me know the thoughts of this group.

Thanks !

 

[planB]

Yes, this is acceptable since applied doses are additive, see also ISO 11137-1, section A.10.11, that applies to deviation, but is transferable to your situation: