H
Hondo812
Hi,
I have a few questions.
I have a fairly new product and need to determine the bioburden limit. Most of what I have read indicates I am supposed to use historical data to set these limits (ala SPC?). But what if I don't have any historical data for product "X"? How do I specify a limit in that case?
Also, how do I co-relate the data from my sterilization qual that indicates "populations" to bioburden data in "CFU's"? Is there some sort of conversion factor at play here?
All answers are appreciated, correct ones more so.
I have a few questions.
I have a fairly new product and need to determine the bioburden limit. Most of what I have read indicates I am supposed to use historical data to set these limits (ala SPC?). But what if I don't have any historical data for product "X"? How do I specify a limit in that case?
Also, how do I co-relate the data from my sterilization qual that indicates "populations" to bioburden data in "CFU's"? Is there some sort of conversion factor at play here?
All answers are appreciated, correct ones more so.