Can anyone define difference between Gamma Validation and dose audits
We have just completed/about to complete Gamma Validation including Bioburden determination, Dose verification, Sterility test and Dose Mapping (in progress) using the VD max25 method
What is the frequency for dose audits using VD max25 method:
1. Do I need to perform whole gamma validation exercise for every three months, which means Bioburden determination, dose verification and sterility test, dose mapping
or
I can just do bio-burden determination of 10 samples and sterility test for 10 samples every three months. Once I get enough history on bio-burden then I can perform Gamma Validation on annual basis.
or
I have to do bio-burden determination of 10 samples, dose verification of 10 samples and sterility test of the samples irradiated using verification dose
2. We have routine three month bio-burden monitoring program for other devices. (This product is not a family type product)
3. Average Bio-burden we determined for initial 3 batches is 50 CFU as part of this gamma validation exercise
4. VDmax25 method is choice of method as we will be manufacturing devices as per customer requirements for e.g. one batch in every 6 months
Sorry my questions sound bit confusing, as I am very much confused to get the basics clear
We have just completed/about to complete Gamma Validation including Bioburden determination, Dose verification, Sterility test and Dose Mapping (in progress) using the VD max25 method
What is the frequency for dose audits using VD max25 method:
1. Do I need to perform whole gamma validation exercise for every three months, which means Bioburden determination, dose verification and sterility test, dose mapping
or
I can just do bio-burden determination of 10 samples and sterility test for 10 samples every three months. Once I get enough history on bio-burden then I can perform Gamma Validation on annual basis.
or
I have to do bio-burden determination of 10 samples, dose verification of 10 samples and sterility test of the samples irradiated using verification dose
2. We have routine three month bio-burden monitoring program for other devices. (This product is not a family type product)
3. Average Bio-burden we determined for initial 3 batches is 50 CFU as part of this gamma validation exercise
4. VDmax25 method is choice of method as we will be manufacturing devices as per customer requirements for e.g. one batch in every 6 months
Sorry my questions sound bit confusing, as I am very much confused to get the basics clear