Biocomp / bioburden for new MFR

nealster75

Registered
Greetings. Molded plastic parts from MFR A, biocomped, steriled val'd, all is good.
If switching, or adding MFR B, at another location / facility, using the same material, I think I can justify my way out of biocomp, but what kind of bioburden testing would be required / smart to do to show equivalence? (Or maybe i should just say, is bioburden sufficient to show equivalence?)
Thank you in advance.
 

planB

Super Moderator
Bioburden is determined by the number and resistance of viable microorganisms. Thus, these two characteristics have to be evaluated when you want to demonstrate equivalency in a risk-assessment activity, what impact a potentially changed bioburden might have on your final product.

Thereby, your mode of sterilization might be a factor: in case your sterilization validation approach is bioburden based (typical for irradiation sterilization), you may want to repeat elements of your sterilization validation; this is typically not always necessary in case you employ a biological-indicator (BI) based approach (typical for ethylene oxide or steam sterilization).

HTH,
 
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