Hi!
I'm Arianna, QA of a sterile implantable manufacturer.
I should set the frequency of bioburden determination on dm sterilised by EtO, dry heat and gamma rays.
Regarding gamma rays, the ISO 11137-1 sets the frequency at 3 months. For the other two, I have not found anything.
Do you know if there are any specific ISOs? Or do I just write a rationale for the fixed frequency? And if so, which parameters should I choose in your opinion?
I'm sorry for all these questions, but our NB gave us a non-compliance during the surveillance visit and I have trouble justifying the frequency of 6 months rather than a year!
Thank you so much!
I'm Arianna, QA of a sterile implantable manufacturer.
I should set the frequency of bioburden determination on dm sterilised by EtO, dry heat and gamma rays.
Regarding gamma rays, the ISO 11137-1 sets the frequency at 3 months. For the other two, I have not found anything.
Do you know if there are any specific ISOs? Or do I just write a rationale for the fixed frequency? And if so, which parameters should I choose in your opinion?
I'm sorry for all these questions, but our NB gave us a non-compliance during the surveillance visit and I have trouble justifying the frequency of 6 months rather than a year!
Thank you so much!