There are many proven methods to validate radiation doses for all compounded drugs and pharmaceutical drugs. Each uses product bioburden enumeration to quantify the concentration of all live microorganisms. The effective dose for radiation sterilization and dose audits can be pinpointed through bioburden enumeration.
Additionally, each method uses a bioburden organism resistance sterility test or verification dose resistance experiment to ensure accuracy. The size, scope, and expected timeline of the sterilization job determine which method will ultimately be the best.
A typical validation study can furnish results in 10 to 12 weeks because of sequential microbiological testing, though the timeline and the cost hinge on the complexity and size of the tested products. Before scheduling a sterilization validation, manufacture additional samples for the entire validation study. Read more >
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