Hi all,
I have a question about the ISO 11137 standard regarding the reason of doing the dose audit always with the Vdmax 25 originally obtained.
If the production to carry out the substantiation of 25 kGy dose is very clean (bioburden average 0,15) the Vdmax 25 is very low (0,9 kGy according table 9 ISO 11137-2). Then all the sterilization dose audits are carried out with an initial very low Vdmax 25 (0,9 kGy). In this situation there is a probable risk to get positives results in the sterility tests, if the bioburden increases (bioburden average 1,00), with inconvenient consequences.
In this case what do you do?
1. A documented factor of security to increase the initial bioburden average?
2. Modify the Vdmax 25 when you get a higher bioburden?
With these bioburden it does not make much sense, if some positives sterility tests are got, to carry out a confirmatory sterilization dose audit or to conclude that the sterilization dose of 25 kGy is not adequate.
What is your opinion?
Thanks in advance!!
I have a question about the ISO 11137 standard regarding the reason of doing the dose audit always with the Vdmax 25 originally obtained.
If the production to carry out the substantiation of 25 kGy dose is very clean (bioburden average 0,15) the Vdmax 25 is very low (0,9 kGy according table 9 ISO 11137-2). Then all the sterilization dose audits are carried out with an initial very low Vdmax 25 (0,9 kGy). In this situation there is a probable risk to get positives results in the sterility tests, if the bioburden increases (bioburden average 1,00), with inconvenient consequences.
In this case what do you do?
1. A documented factor of security to increase the initial bioburden average?
2. Modify the Vdmax 25 when you get a higher bioburden?
With these bioburden it does not make much sense, if some positives sterility tests are got, to carry out a confirmatory sterilization dose audit or to conclude that the sterilization dose of 25 kGy is not adequate.
What is your opinion?
Thanks in advance!!