Sterility and Bioburden Testing - LAL passed under 0.5EU/mL

#1
What may be the reason for Bioburden to come in high with Gram positive cocci and then for Sterility results to come in high (fail) with Gram positive rods?

LAL passed under 0.5EU/mL.
 
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planB

Super Moderator
#2
Cleslie,

could you be a little more specific:

Which sterilization method do you employ?
What level of bioburden did you encounter?
After which validation activity did you encounter the failed sterility test on how many samples out of what overall number of samples?

Side note: Bioburden and bacterial endotoxins (which can be tested via an LAL test) are typically not correlated. This is why you typically test for both of them for devices in blood contact during their intended use.
 
#3
Cleslie,

could you be a little more specific:

Which sterilization method do you employ?
What level of bioburden did you encounter?
After which validation activity did you encounter the failed sterility test on how many samples out of what overall number of samples?

Side note: Bioburden and bacterial endotoxins (which can be tested via an LAL test) are typically not correlated. This is why you typically test for both of them for devices in blood contact during their intended use.
Hi planB,

A steam sterilization method was used
Bioburden came in at 99 CFU (limit is 100)
Sterility test was performed after sterilization on 20 random samples. 8 out of 20 samples came back with growth
 

planB

Super Moderator
#4
Cleslie,

did you employ biological indicators during your validation? If yes, which one and were they inactivated (e.g. in half cycle approach)?
What are your full cycle parameters? Which SAL are you aiming at? Which validation guidelines are you following?
 
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