F
Frodeno
Due to some project team issues I have had to take over a project to validate a sterilization process for a class IIb product. All of the dose verification activities have been completed and as I read the standard the information seems to be in good shape (the VDmax 25 method was used). However, I am a bit confused about the requirement from the standard (ISO 11137) for maximum dose establishment . Will an auditor expect so see complete product performance data including packaging repeated at the max dose ? it seems that this would be required according to the standard. Also, does this mean that shelf life would have to be repeated after max dose irradiation ? In some respects this ssems to be more of a design verification activity than process validation. Although there is a lot of information out there on establishment of the minimum dose there appears to be very little regardind the maximum dose. So if anyone could help me out with understanding the requirements for max dose it would be greatly appreciated. Also, can any of this be rationalised rather than fully tested.
Thanksin advance.
Thanksin advance.