Mochizuki0124
Explorer
Does anyone here have experience with these labs and the testing they offer? I've noticed a few groups beginning to use them.
Sterigenix and MZ Biolabs
- Thread starter Mochizuki0124
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shirasu893
Explorer
I got a COA back from SteriGenix today for the "Extended Panel" run on the R60 sample I submitted. That panel covers M/P, identity confirmation, Endos, Sterility, and Heavy Metals — at $350, it struck me as an unbelievably good deal. Still, I have nothing to go on when judging whether the numbers they report are accurate or not. The sample arrived with them on July 27, and on August 4 they sent me a link to the finished COA.
One thing that puzzled me was the sterility finding, listed as "Bacterial Growth (Accelerator): No Growth." That was reassuring, but August 4 was just 8 days after they received the sample, while their Extended Panel description says the sterility assay is USP <71> (14-day membrane filtration). So I wrote to them asking about this apparent mismatch. No response so far.
Earlier I had asked SteriGenix how their endotoxin assay is run. With Jano, if the first assay comes back out of range and the customer wants something more precise than Jano's estimate of the out-of-range EU/vial value, a fresh sample is required. SteriGenix told me they do successive dilutions using the original sample until the assay lands inside the accuracy range of the current run — which looks to me like the right way to handle it.
One thing that puzzled me was the sterility finding, listed as "Bacterial Growth (Accelerator): No Growth." That was reassuring, but August 4 was just 8 days after they received the sample, while their Extended Panel description says the sterility assay is USP <71> (14-day membrane filtration). So I wrote to them asking about this apparent mismatch. No response so far.
Earlier I had asked SteriGenix how their endotoxin assay is run. With Jano, if the first assay comes back out of range and the customer wants something more precise than Jano's estimate of the out-of-range EU/vial value, a fresh sample is required. SteriGenix told me they do successive dilutions using the original sample until the assay lands inside the accuracy range of the current run — which looks to me like the right way to handle it.
AngieHolmes
Explorer
MZ Biolabs, sure — I know the name but haven't placed an order; they're noted on a list of mine. As for Sterigenix, that one's unfamiliar to me. What information do you have? With demand being what it is, I figure additional labs will appear, so the challenge becomes sorting the trustworthy operations from the ones that won't last . . .